Rabeprazole |
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Contraindications -Hypersensitivity to this agent, other PPIs omeprazole, lansoprazole, pantoprazole, esomeprazole ; , or any component of the drug product. Precautions - Prior to initiating therapy for suspected gastric ulcer, malignancy must be ruled out, as alleviation of symptoms may delay diagnosis of malignancy. - Caution in severe hepatic dysfunction; dosage reduction should be considered. - A reduction of serum vitamin B 12 levels may occur occasionally in the following situations: patients with Zollinger-Ellison syndrome who experience sustained achlorhydria while receiving long-term therapy with PPIs, during treatment of patients with poor diets, and possibly in the elderly. Periodic monitoring of vitamin B 12 levels is recommended in these patients. - No data available regarding safety and efficacy in children. - As with administration of other PPIs, gastric enterochromaffin-like cell hyperplasia secondary to hypergastrinemia may occur with rabeprazole therapy; however, no clinically important increases in these cells have been detected following long-term therapy with PPIs, and this effect has not been associated with dysplastic, neoplastic, or adenomatoid changes. - Fundic gland polyps, which are visualized during endoscopy and are believed not to be of clinical significance, have been reported in patients receiving long-term therapy with PPIs; controversy exists as to the cause of these polyps, and further study is necessary to evaluate the role of administration of PPIs as a causative factor. - Report any unexpected or serious adverse reactions to Health Canada's adverse drug reaction monitoring program toll free telephone 1-866-234-2345, toll free fax 1-866-678-6789.
Expend? Similarly, should ESTIMATED IMPACT OF DETAILING CHANGES Janssen pull back on its rabeprazole Aciphex ; FOR HEALINEX promotion to increase Exhibit 1 efforts on its antipsychotic, risperidone Risperdal ; ? Est. Est. Revenue Let's look at a hypothetiEst. Change in Change cal example to understand Change Initial Rxs across Factors in the data and logic these % Change in Number Share 4 Months Factors in Patient companies will need to folin Detailing of Details Change Physician Persistence ; Persistence ; low. Note: The figures + 10% 300 0.35% 2, 000 used in the following exNo Change No Change 0.25% 6, 200 7, 000 ample have been drawn -10% -300 0.00% 0 ##TEXT## from real-life analyses, although the scenario itself FOR PAINAWAY has been fictionalized. ; ExExhibit 2 emplar Pharmaceuticals is Overall Est. Est. Revenue about to get a big break for Change in Change its flagship product, Change Est. Initial Rxs Factors Factors in Healinex, an anti-infective. % Change in Number Share in Physician Patient It's main competitor, in Detailing of Details Change Persistence ; Persistence ; Curitall Co., is expecting + 30% * 300 0.50% 2, 7, 000 FDA approval to market a new product in another No Change No Change 0.00% 0 ##TEXT## therapeutic category. If its -30% -300 -0.50% -2, 580 -7, 000 past behavior is any indication, Curitall will draw 20% * Note that shifting 300 details for Painaway makes for a greater of its detailing resources percentage change than for Healinex because Exemplar normally plans fewer details for Painaway. away from Healinex's market for a month in order to SOURCE: ImpactRx support its new product launch. That will automatically increase the share of physician attention that Exemplar's Healinex earns in its class. A quick analysis with data that links promotion to prescribing shows that, if Examplar doesn't change any of its behavior, Healinex should realize a windfall of 6, 200 additional prescriptions over four months. But such a simple analysis misses out on the real opportunity that Curitall's new product launch offers. Exemplar could, for example, shift additional resources to Healinex and thus force a larger gain while Curitall cannot readily respond. Or it could follow Curitall's lead and divert some of its resources to another product, Painaway, an analgesic, while maintaining Healinex's overall share of physician attention. Or it could vary the amount of detailing effort it shifts under either scenario, adjusting the dials for any number of permutations. To select the most profitable option, Exemplar must assemble various facts about Healinex's market and that of Painaway. Specifically, Exemplar must determine for both products. Offered teachings as undisputed, the submissions are insufficient to sustain a judgment by clear and convincing evidence that the ordinary skilled person would have made the particular combination alleged of lansoprazole, the '431 patent, and the Brandstrom article, reasonably expecting rabeprazole to result. Specifically, defendant's submissions fall far short of sufficiency to prove the usage Teva claims would have been made of the '726 patent.4 The critical material facts are not in dispute. Eisai agrees that the prior art would include references extant as of November 13, 1986. P. Mem. 7; D. Mem. 4. ; For the purposes of its motion, Eisai concedes that the person of ordinary skill in the relevant art should be defined as Teva contends; 5 that the scope of the prior art covers the three items cited by Teva, the '726 patent, the '431 patent, and the Brandstrom article; and that lansoprazole's structure differs from rabeprazole's only by its trifluoroethyoxy OCH2CF3 ; substituent at the 4-position of the pyridine ring, where rabeprazole bears a methoxypropoxy OCH2CH2CH2OCH3 ; substituent. P. Reply Mem. 4, n.3; see D. Mem. 8 for more detailed description of substituents. ; Eisai has.
Determination of rabeprazole
Note: All patients must be on a proton pump inhibitor lansoprazole, omeprazole, pantoprazole sodium, rabeprazole sodium ; . If any new epigastric pain develops, ulceration should be expected and sucralfate should be started. Upper endoscopy should be performed as clinically directed. Capecitabine and Bevacizumab with Concurrent Radiation Agent Capecitabine refer to Appendix VI ; + Bevacizumab Dose 825 mg m2 5 mg kg Route po IV Schedule q 12 hours Monday through Friday on radiation days On days 1, 15, and 29 of chemoradiation and pantoprazole. Giles, with rabeprazole domperidone combination much gravity. Goods Services: fresh fruit, fresh greens and fresh vegetables. Conditions of registration: Registration gives no right to the exclusive use of the word 'Fruta' when used apart from the mark. Trade Mark No: Filing Date: 38999 22 Apr 2003 Priority Date and dicyclomine.
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Analysis of healing or prevention was not possible in most head-to-head trials, due to the small numbers of older patients. However, two trials did assess the impact of age, gender and race on the incidence of adverse effects.6, 126 There were no differences between PPIs omeprazole, rabeprazole, esomeprazole ; based on these characteristics. In addition, the effect of age on eradication rates was evaluated.175 This study found higher eradication rates among patients older than 50 years compared to patients younger than 50, but comparison of PPIs was made. In trials comparing a PPI to another drug, the same general statements can be made, but a few findings deserve comment. Studies of healing NSAID-induced ulcer, and prevention of NSAID-induced ulcer included more women than men with the proportion of women ranging from 62 to 67%, and 64 to 83%, respectively. This is most likely due to the greater prevalence of women in the diseases requiring long-term NSAID treatment. However, no gender-based analyses were presented. Genotype The PPIs are all metabolized, largely by the CYP2C19 and CYP3A4 liver enzymes. This enzyme is estimated to be deficient in 3% of white and African Americans, and 17-25% of Asians. This results in a significantly longer half-life, although clinically significant accumulation of these drugs has not been shown. While dose adjustments are not required, and adverse effect profiles of the drugs do not differ, there is some evidence that lower doses may be effective in these populations, 168, 216 and that rapid metabolizers may have a higher failure rate in eradicating H. pylori163, 171, 217 and esophagitis healing.218 Results of subgroup analysis found no effect by race in one study of esomeprazole and lansoprazole in healing erosive esophagitis5. A small study n 80 ; found no statistically significant differences in ulcer healing rate at 8 weeks between rabeprazole 10 mg a day and omeprazole 20 mg a day among patients with differing CYP2C19 genotypes.128 Adverse events were few and were not analyzed by genotype. A trial of omeprazole in Japanese patients with recurrent esophagitis found no differences in efficacy or safety by genotype.219 Older patients also metabolize PPIs more slowly, resulting in significantly higher drug levels and half-lives. However, accumulation has not been shown, and dose adjustments are not recommended. One re-analysis of data from two trials of omeprazole versus either ranitidine or cimetidine for reflux esophagitis examined differences in effects in those age 65 or older compared to under age 65.220 In this analysis, there were no differences in healing rate or in symptom resolution at 4 and 8 weeks, with slightly higher proportion of older patients both healed and symptom-free. Withdrawals due to adverse events were higher in the older group, 7.6% versus 2.5%. This was not a comparative trial, and similar data are not available for other PPIs. Pregnancy A multicenter, prospective cohort study enrolled 410 pregnant women who had sought counseling after exposure to omeprazole N 295 ; , lansoprazole N 62 ; , or pantoprazole N 53 ; between 1992 and 2001.221 Details of exposure were collected during pregnancy before pregnancy outcome was known, and followup was performed in the neonatal period. A control. 2f. Date of Birth DD MMM YY and albuterol. Most of the time the will take blood because here is no way to fool a blood testing ually i would give you some recipe.
Buy cheap Rabeprzzole onlineRabeprazole sodium suppresses gastric acid secretion by the specific inhibition of the H + K ATPase enzyme proton pump ; at the secretory surface of the gastric parietal cell thereby blocking the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus. Animal studies indicate that after administration, rabeprazole sodium rapidly disappears from both the plasma and gastric mucosa and salbutamol. Zhou L, Zhang Q, Stein C and Schfer M 1998 ; Contribution of opioid receptors on primary afferent versus sympathetic neurons to peripheral opioid analgesia. J Pharmacol Exp Ther 286: 1000-1006.Maastricht 2-2000 Consensus Report suggests a quadruple therapy based on bismuth 120 mg, q.i.d. ; , tetracycline 500 mg, q.i.d. ; , metronidazole 500 mg, t.i.d. ; and antisecretive agent PPI, b.i.d. ; for a minimum of 7 d [12]. Further trials have shown that replacing the proton pump inhibitor and the bismuth compound of the quadruple therapy by RBC also achieves good results, with an eradication rate ranging between 57%-95% [36-39]. The failure of second line quadruple therapy is associated with its discontinuation because of the high incidence of side effects 6%-68% ; [40]. Low compliance for the high number of pills to be taken each day also affects the clinical results [24] . However, in second-line regimens, new combination of drugs has been used. A triple therapy with the combination of levofloxacin, rabeprazole and tinidazole or amoxicillin has been proposed as an alternative to Maastricht [41]. This protocol shows an eradication rate higher than 90% compared to quadruple therapies given for 7 d 63% ; with a lower incidence of side effects [42]. Rifabutin has been shown to have a good eradication rate 87% ; , if administered at a high dose 300 mg ; in combination with amoxicillin and PPI, as compared to quadruple therapy [43-47]. Rifabutin shows an important side effect mielotoxicity ; [46]. Wong et al [43] showed that a combination of levofloxacin, rifabutin and rabeprazole has a high efficacy with an eradication rate 90% [43]. Furazolidone is also used to replace metronidazole in quadruple therapy [48-51]. Different in vivo studies have confirmed the efficacy of regimens containing a high-dose furazolidone [200 mg, b.i.d.] as the second-line therapy in patients with metronidazole-resistance [48-51]. Many other combinations have been used [31] with various rates of success. Bacterial eradication may fail in up to 40% of cases after the suggested second-line regimens. As a consequence, to treat patients who have already undergone the first- and second-line therapies is a common challenge and fluticasone.
| Rabeprazole no prescriptionAs the months progressed, i started having anxiety issues again, never happened before ; , had severe cystic acne always had good skin ; , bloating to the point that i looked the way i did when i was 5 months pregnant, headaches every single day, extreme fatigue, blurry vision, complete inability to concentrate, mental fog, insomnia and my libido was in the toilet.Aciphex rabeprazole sodium ; Tablets * Alamast pemirolast potassium ophtha lmic solution ; Axert almotriptan malate ; Tablets Betimol timolol ophthalmic solution ; Bicitra sodium citrate and citric acid oral solution, USP ; Concerta methylphenidate HCl ; Tablets Ditropan oxybutynin chloride ; Tablets and Syrup Ditropan XL oxybutynin chloride ; Extended ReleaseTablets Duragesic fentanyl transdermal system ; CII Elmiron pentosan polysulfate sodium ; Capsule s Flexeril cyclobenzaprine HCl ; Tablets Floxin ofloxacin ; Tablets Grifulvin V griseofulvin ; Tablets Grifulvin V griseofulvin oral suspension ; Suspension Haldol haloperidol ; Decanoate Injection Haldol haloperidol ; Injection Levaquin levofloxacin ; Tablets Monistat-Derm miconazole nitrate cream 2% ; Mycelex clotrimazole ; Troche Neutra -Phos oral sodium and potassium phosphate mixture ; Neutra-Phos-K oral potassium phosphate mixture ; Pancrease pancrelipase ; Capsules Pancrease MT pancrelipase ; Capsules PolyCitra Syrup tricitrates oral solution ; PolyCitra LC tricitrates oral solution ; PolyCitra -K potassium citrate and citric acid for oral solution, USP ; PolyCitra -K Crystals potassium citrate and citric acid for oral solution ; Quixin levofloxacin ophthalmic solution ; Regranex becaplermin ; Gel 0.01% Reminyl galantamine HBr ; Tablets Reminyl galantamine HBr ; Oral Solution Renova tretinoin emo llient cream ; Retin -A tretinoin ; Cream, Gel, Liquid, or Micro Risperdal risperidone ; Tablets Risperdal risperidone ; Oral Solution Risperdal risperidone ; M-TABTM Spectazole econazole nitrate ; Cream Sporanox itraconazole ; Capsules Sporanox itraconazole ; Oral Solution Terazol terconazole ; 3 Vaginal Cream or Suppositories Terazol terconazole ; 7 Vaginal Cream Tolectin DS tolmetin sodium ; Capsules Tolectin tolmetin sodium ; Tablets Topamax topiramate ; Tablets Topamax topiramate ; Sprinkle Capsules Ultram tramadol hydrochloride ; Tablets UltracetTM tramadol hydrochloride acetaminophen ; Tablets Urispas flavoxate HCl ; Tablets Vermox mebendazole ; Tablets and dexamethasone. Only prior-art reference that specifically taught the use of a methoxypropoxy 4-position substituent. Teva Mem. 30; Reddy Mem. 34. ; Eisai repeatedly highlighted this particular feature of rabeprazole in its submissions to examiner Fan at one point indicating it was a basis for "novelty" and thus rendered any contradictory information material, defendants urge. Teva Mem. 28. ; While the ethyl homolog rejections from the relevant period do not specifically mention methoxypropoxy, defendants presumably although not explicitly aver that Fan, if alerted to the substance of the ethyl homolog rejections, could have uncovered this detail of Byk Gulden on her own. Such a discovery could have formed the basis of an obviousness rejection of rabeprazole, defendants allege. Teva Mem. 28. ; Eisai does not dispute that Byk Gulden teaches a methoxypropoxy at the pyridine ring's 4-position, but it protests that the prior-art disclosure encompasses "over 30 billion possible compounds." P. Mem. 34, emphasis in original. ; It charges that it is "pure hindsight for [defendants] to create a compound by starting with rabeprazole and making numerous choices out of the multiple paths possible in this enormous disclosure." Id.; see id. at 33 n.23 for undisputed description of Byk Gulden's methoxypropoxy disclosure. ; Moreover, Eisai points out, Byk Gulden does not offer examples of any actual proton-pump inhibiting compounds featuring a methoxypropoxy at the 4-position of the pyridine ring, but merely discloses the possibility of the substitution. Id. at 34-35; P. Reply Mem. 12-13. ; Defendants do not dispute this characterization. Further, Eisai uncontestedly submits that the '013 patent application examiners did not themselves identify Byk Gulden's specific mention of methoxypropoxy until 1996, after Eisai had elected to exclude the ethyl homolog from that application's claims and many years after the '552 patent had issued. P. Mem. 36, citing Killworth Decl. 84-86; see. |
In certain instances herbs can be used as strong medicines, especially when concentrated and mixed with other substances; however, the intent of herbs is to provide food for health.
Nor has Eisai proved the lack of a genuine issue as to its intent in not disclosing the copendency of the '013 patent application to the rabeprazole examiner. Besides disputing the materiality of the information, Eisai submits that its patent attorney and others involved in the '552 patent application simply did not believe that their disclosure duty covered information from a "later-filed" application. P. Reply Mem. 20; P. Mem. 43-44; Killworth Decl. 101. ; Plaintiffs do not counter defendants' argument see, e.g., Teva Mem. 33 ; , that, at the least, Eisai was put on notice of a potentially important overlap between the separate applications claiming homologs when Fan wrote in her first rejection of rabeprazole, "[prior] art compounds are homologs of the claimed compounds rendering the claimed compounds unpatentable." '552 File History at DRLRAB 292-93. ; Eisai instead protests that "there is no allegation that Eisai tried to `steer' the '013 patent application to a different examiner from the rabeprazole application." P. Reply Mem. 26. ; But such "smoking gun" evidence of deception is not required. A reasonable factfinder need not accept protestations of ignorance where the materiality of the nondisclosure is great. Here, Eisai has neither diminished the degree of materiality nor offered exonerating evidence such that a reasonable factfinder could not infer that it intended to deceive rabeprazole's examiner by withholding the fact of the '013 patent application's co-pendency. Case law strongly supports the conclusion that the failure to disclose material co-pending applications is powerful evidence of intent to deceive. The patentee in Dayco only escaped summary judgment of inequitable conduct by showing that it had actually disclosed the fact of co-pendency in one of the concurrent prosecutions. The court there ruled that the disclosure in one application left at least a triable issue as to the accused's intent to deceive the PTO. 329 and salmeterol. Mediated 1 -hydroxymidazolam formation were investigated in HLM. Pantoprazole showed a stronger inhibitory effect Ki 22 M ; midazolam 1 -hydroxylation than omeprazole Ki 42 M ; , esomeprazole Ki 47 M ; , and rabeprazole Ki 51 M ; The IC50 of lansoprazole was over 200 M. The pattern of inhibition was established to be competitive by fitting the data to different inhibitory models. Omeprazole and its enantiomers showed similar inhibitory effects on the production of the 1 -hydroxylated metabolite of midazolam. Again, the inhibitory potency of rabeprazole thioether to CYP3A4 activity in HLM was about 3-fold higher than that of its parent compound. Discussion In this study, we investigated the inhibitory effects of the five currently available PPIs i.e., omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole ; on four human P450 enzymes CYP2C9, 2C19, 2D6 and 3A4 ; using human liver microsomal preparations to assess their potential of interaction with coadministered drugs that are metabolized by these enzymes. Several pharmacokinetic studies have been performed on the five PPIs in healthy Smephenytoin EMs and PMs Table 1 ; . After therapeutically repeated doses, the range of maximum plasma concentration of each PPI in EMs was 1 to 5 M, with omeprazole and pantoprazole in the low and high ends, respectively. In PMs, the range was 2 to 10 M, with rabeprazole and pantoprazole in the low and high ends, respectively. The ratio of the mean AUC values in PMs versus EMs was about 1to 2-fold for esomeprazole, 2- to 5-fold for rabeprazole, and about 5-fold for omeprazole, lansoprazole, and pantoprazole, indicating considerable variation in drug exposure between EMs and PMs for the five compounds Table 1 ; . Because the Ki values determined in our study for certain P450 enzyme and PPI combinations are in the same order of magnitude as the plasma levels encountered in vivo, this might point to the potential of DDIs for any of the five PPIs during multidrug treatment. PPl drug-drug interactions in vivo have been reviewed thoroughly Andersson, 1996; Steinijans et al., 1997; Jungnickel, 2000; Andersson et al., 2001a; Gerson and Triadafilopoulos, 2001; Fuhr and Jetter, 2002; Vanderhoff and Tahboub, 2002 ; , and conclusions have been drawn that no clinically relevant DDIs exist for this class of compounds. However, the potential of possible clinical interactions is not fully explored for all PPIs [e.g., rabeprazole Fuhr and Jetter, 2002 ; ], and the population under study may also influence the conclusion of clinical studies Chong and Ensom, 2003 ; e.g., most of the rabeprazole studies were performed in Japanese men ; . Several in vivo DDI studies claim a significant inhibition of CYP2C19 by omeprazole, [e.g., the ability of omeprazole to inhibit diazepam clearance in humans Gugler and Jensen, 1985; Ishizaki et al., 1995 ; ]. This seems to be due to the fact that CYP2C19 plays a major role in the primary metabolism of both omeprazole and diazepam. In a study on genotyped subjects Andersson et al., 1990 ; , the diazepam-omeprazole drug interaction could be attributed to.
After a year, i was down to 2 a day, and after another few months, down to 1 a day.
27 . Gerson L, Robbins A, Garber A, Hornberger JTG. A cost-effectiveness analysis of prescribing strategies in the management of gastroesophageal reflux disease. J Gastroenterol 2000; 95: 397-407 Goeree R, O'Brien BJ, Blackhouse G, Marshall J, Briggs A, Lad R. Costeffectiveness and cost-utility of long-term management strategies for heartburn. Value Health 2002 Jul; 5 4 ; : 312-28. 29 . Bate CM, Green JR, Axon AT, Murray FE, Tildesley G, Emmas CE, et al. Omeprazole is more effective than cimetidine for the relief of all grades of gastrooesophageal reflux disease-associated heartburn, irrespective of the presence or absence of endoscopic oesophagitis. Aliment Pharmacol Ther 1997 Aug; 11 4 ; : 755-63. 30 . Dehn TC, Shepherd HA, Colin-Jones D, Kettlewell mg, Carroll NJ. Double blind comparison of omeprazole 40 mg od ; versus cimetidine 400 mg qd ; in the treatment of symptomatic erosive reflux oesophagitis, assessed endoscopically, histologically and by 24 h monitoring. GUT 1990 May; 31 5 ; : 509-13. 31 . Bochenek WJ, Mack ME, Fraga PD, Metz DC. Pantoprazole provides rapid and sustained symptomatic relief in patients treated for erosive oesophagitis. Aliment Pharmacol Ther 2004 Nov 15; 20 10 ; : 1105-14. 32 . Kovacs TO, Wilcox CM, DeVault K, Miska D, Bochenek W. Comparison of the efficacy of pantoprazole vs. nizatidine in the treatment of erosive oesophagitis: a randomized, active-controlled, double-blind study. Aliment Pharmacol Ther 2002 Dec; 16 12 ; : 2043-52. 33 . Armstrong K, Schwartz JS, Fitzgerald G, Putt M, Ubel PA. Effect of framing as gain versus loss on understanding and hypothetical treatment choices: survival and mortality curves. Med Decis Making 2002 Jan; 22 1 ; : 76-83. 34 . Farley A, Wruble LD, Humphries TJ. Raebprazole versus ranitidine for the treatment of erosive gastroesophageal reflux disease: a double-blind, randomized clinical trial. Raberprazole Study Group. J Gastroenterol 2000 Aug; 95 8 ; : 1894-9. 35 . Bardhan KD, Hawkey CJ, Long RG, Morgan AG, Wormsley KG, Moules IK, et al. Lansoprazole versus ranitidine for the treatment of reflux oesophagitis. UK Lansoprazole Clinical Research Group. Aliment Pharmacol Ther 1995 Apr; 9 2 ; : 145-51. 36 . Frame MH. Omeprazole produces significantly greater healing of erosive or ulcerative reflux oesophagitis than ranitidine. The Italian Reflux Oesophagitis Study Group. Eur J Gastroenterol Hepatol 1991; 3 7 ; : 511-7. 37 . Havelund T, Laursen LS, Skoubo-Kristensen E, Andersen BN, Pedersen SA, Jensen KB, et al. Omeprazole and ranitidine in treatment of reflux oesophagitis.
Pump inhibitors such as omeprazole, rabeprazole and lansoprazole, which are used to treat a form of acid reflux disease. Amine drugs also include compounds commonly used for pain relief, antidepressants, and amphetamines such as Ritalin. Dermatrends is currently working with pharmaceutical partners to bring its technology to consumers. Dermatrends Inc is a privately held medical research and development company based in Minneapolis, MN, with scientific laboratories in San Diego, CA. DURECT Announces Positive Clinical Results With Its ORADUR TM ; Sustained Release Oral Gel-Cap Technology PR Newswire via NewsEdge Corporation: CUPERTINO, Calif., July 6 -- DURECT Corporation Nasdaq: DRRX ; announced the advancement of its ORADURTM sustained release oral gel-cap technology formerly referred to as the SABERTM oral gel-cap technology ; with positive human clinical results for RemoxyTM. Remoxy is a novel long-acting oral formulation of oxycodone based on DURECT's ORADUR technology under development by Pain Therapeutics, Inc., which is targeted to decrease the potential for drug misuse or abuse. On June 29, 2004, Pain Therapeutics announced the results of studies conducted in human volunteers in the United Kingdom to confirm Remoxy's anti-abuse properties and to assess the drug's pharmacokinetics. Ultrasound could be used to get drugs to tumors - Drug Delivery NewsRxCancer via NewsEdge Corporation: 2004 JUL 6 -- Ultrasound scans might be most familiar for getting a peek at a developing fetus, but the technology could also be used to treat cancer. A partnership between the University of California UC ; Davis, Siemens Medical Systems and ImaRx, Inc., funded by a U.S. National Cancer Institute grant, will study ways to deliver drugs to tumors using focused ultrasound. The plan is to put cancer-fighting drugs into tiny capsules that are injected into the bloodstream and can be steered to a tumor using ultrasound. Once there, the capsules target the tumor through antibodies or other molecules coating the capsule surface. They can also be burst open with a focused pulse of ultrasound. "The idea is to locally concentrate the drug, " said Katherine Ferrara, professor and chair of biomedical engineering at UC Davis and principal investigator on the grant. Many cancer drugs have toxic side effects. By concentrating the drug capsules in the tumor, the total dose of drug affecting the rest of the body can be reduced, she said. UC Davis researchers led by Ferrara will carry out preclinical studies on the system. Siemens Medical Systems will design and build the imaging equipment, including developing ways to direct pulses of ultrasound to a threedimensional volume. ImaRx, Inc., of Tucson, Arizona, makes the capsules for drug delivery. QLT to broaden with acquisition of Atrix CHEMICAL BUSINESS NEWSBASE CHEMICAL AND ENGINEERING NEWS, June 30: Biotechnology company QLT is to acquire Atrix Laboratories in a share and cash transaction valued at 5 M. QLT has one approved drug, Visudyne. Atrix has Eligard leuprolide acetate ; , approved for prostate cancer, and also brings with it the Atrigel sustained-release drug delivery system. Two other Atrix products are expected to reach the market in 2005: a sustained-release version of Eligard, and Atrisone, a topical acne product. Atrix had sales of M in 2003 and has strategic alliances with companies including Pfizer, Novartis, and Aventis. It is expected to be profitable in 2004. Although QLT says it has branched out into dermatology, oncology, and urology, industry observers say the company is under pressure in its core area of ocular disease because of new drugs under development at Eyetech Pharmaceuticals, Genentech, and elsewhere. OctoPlus Grants SurModics Access to Two Biodegradable Polymer Families for Medical Device Applications PR Newswire via NewsEdge Corporation: LEIDEN, The Netherlands, June 29 -- OctoPlus, a drug delivery and development company, announced today that it has granted SurModics, Inc. Nasdaq: SRDX ; , a leading provider of surface modification and drug delivery solutions to the medical device industry, an option to acquire an exclusive license to two novel classes of biodegradable polymers for use in the site specific delivery of drugs from medical devices. The agreement is an important step for OctoPlus to accelerate the proliferation of its proprietary polymer platforms, through SurModics, in the development of drug eluting medical devices, for example, drug eluting stents. The two polymer families covered under this agreement are PolyActive TM ; and OctoDEX TM ; , which are currently under pre-clinical and clinical evaluation by OctoPlus for use as pharmaceutical drug delivery products. PolyActive TM ; is a biodegradable multiblock polymeric drug delivery system based on two well-known polymers. Its biodegradability, extensive safety record and tunable release properties make it an excellent choice for the controlled release of proteins and hydrophobic small molecule drugs. In particular, PolyActive TM ; has been used in thousands of patients as part of two FDA approved products, and has an existing FDA Master File. OctoDEX TM ; is a delivery system for the controlled release of proteins and large particles such as liposomes and antigens and is based on cross-linked dextran microspheres. OctoPlus recently reported successful completion of Phase I studies for a sustained release formulation of human growth hormone based on OctoDEX TM ; . DURECT Corporation and NeuroSystec Corporation Announce Exclusive Agreement to Develop Treatments for Certain Inner Ear Disorders Including Tinnitus PR Newswire via NewsEdge Corporation : CUPERTINO, Calif., and VALENCIA, Calif., June 21 -- DURECT Corporation Nasdaq: DRRX ; and NeuroSystec Corporation "NeuroSystec" ; , a privately held company located in Valencia, CA, announced the signing of an exclusive agreement to develop, market and sell products for the treatment of certain inner ear disorders including chronic tinnitus ringing in the ears ; . Under the agreement, DURECT granted to NeuroSystec exclusive worldwide rights to develop and commercialize products designed for the treatment of tinnitus and to improve post-operative recovery and tolerance of surgical implantation of cochlear devices using specified DURECT proprietary drug treatment methods and drug delivery technologies to deliver precise doses of appropriate medications directly to the middle or inner ear. "DURECT's portfolio of innovative otologic drug treatment methods and drug delivery technologies and the groundbreaking tinnitus research already conducted by DURECT and its collaborators provide a compelling reason to believe that we will one day be able to offer an effective treatment for the millions of patients in the US and abroad who suffer constantly with this debilitating disease, " stated Alfred E. Mann, Chairman of NeuroSystec. "Tinnitus is truly an unmet medical need affecting millions of people. We are very excited to work with DURECT to develop the first promising therapy under this agreement, " added Dr. Stephen McCormack, President and CEO of NeuroSystec. "Alfred Mann brings to this collaboration his impressive track record of vision and success at other companies he has founded such as Advanced Bionics, Minimed, Pacesetter, and Mannkind. We are delighted to have the opportunity to collaborate on such an innovative and meaningful venture with Mr. Mann, Dr. McCormack and their team at NeuroSystec, " stated Felix Theeuwes, Chairman and Chief Scientific Officer of DURECT. "This collaboration demonstrates the strengths of DURECT's pharmacological research capabilities, as well as the breadth of applications for DURECT's drug delivery technologies, and we anticipate will create products that will offer hope to millions of tinnitus sufferers around the world, " added James E. Brown, DVM, President and CEO of DURECT. Antares Pharma Announces DPT Laboratories, Ltd. is Preferred Supplier of Transdermal Gel Technologies PR Newswire via NewsEdge Corporation : EXTON, Pa., June 16 -- Antares Pharma Inc. OTC Bulletin Board: ANTR ; and DPT Laboratories, Ltd. today announced a letter agreement between the companies whereby DPT will become the preferred development and manufacturing organization for Antares Pharma's transdermal gel products for clients referred to DPT by Antares Pharma. Commenting on this agreement, Dr. Roger G. Harrison, CEO and President of Antares Pharma, said, "Initiation of this agreement. H2 receptor antagonists are no longer the drugs of choice for patients with ZES, even if they have actually been proven effective in alleviating the symptoms and healing ulcers in gastrinomas. Ranitidine is the drug of choice among the H2 antagonists, due to its low side effects and its limited interaction with other drugs. However, despite the first excellent results, long-term studies have shown that the use of these drugs is limited by many factors such as poor control of the gastric acid hypersecretion and sometimes the need for high and frequent doses of the drug[60]. The pharmacological basis of these observations is unknown, even if various possibilities have been suggested, such as a diminished bioavailability due to reduced absorption, an altered metabolism of the drug with increased excretion, the development of tachyphlaxis and the hypersecretory state itself[61]. The poor effectiveness of H2 antagonists is usually evident in ZES associated with severe gastroesophageal reflux, MEN 1 with hyperparathyroidism and partial gastric resection[62]. Proton pump inhibitors Omeprazole, the first proton pump inhibitor available, belongs to a new class of drugs which has proven to be safe and effective in controlling gastric hypersecretion in patients with ZES and has completely substituted the use of H2 antagonists. The PPIs commonly used are omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole[63]. These drugs show differences in pharmokinetics and pharmodynamics, but it is not always clear, if these fine variations have clinical importance[64]. Initial therapy The goal of ZES therapy is to obtain improvement of the symptoms and healing of the ulcers by controlling the gastric hypersecretion. Various studies have shown that a reliable criterion for the control of the hypersecretion is the reduction of the BAO below 10 mEq h in the hour preceding the next administration of the drug in cases of uncomplicated ZES and below 5 mEq h in cases of ZES associated with MEN 1, gastro-esophageal reflux disease or in patients undergoing a partial gastrectomy[2, 65]. Using the acute upward dose titration method, widely accepted for establishing the initial dosage of omeprazole, some studies have demonstrated that the average dosage of omeprazole capable of controlling gastric hypersecretion in the majority of patients is between 60 and 100 mg of the drug per day[66]. The only reliable parameter able to demonstrate the absence of damage to the mucosa is the level of acid inhibition when the "steady state" has been reached; therefore, the BAO must be measured every 3-4 wk and the patient should be evaluated by endoscopy and acid secretion analysis at intervals from 3 to 6 and, successively, from 6 to 12 mo. The objective of the therapy is not achlorhydria, but a BAO between 1 and 10 mmol h; if complete inhibition of the acid hypersecretion is seen, the dosage of omeprazole should be reduced by 50% and the patient should be re-evaluated. If the BAO is greater than 10 mmol h, the dosage of the PPI should be increased gradually and, for doses of omeprazole over 60 mg or equivalent doses of another PPI ; , it would be advisable to and buy pantoprazole. A. Caos et al. 5abeprazole for the prevention of pathologic and symptomatic relapse of erosive and ulcerative gastroesophageal reflux disease. Gastroenterology 1999; 116: A132.
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