CONCLUSIONS: In certain cancer patients with strong pain, Pharmacy achieved good pain control with fewer side-effects than morphine. The non-opioid mode of action may result in a different spectrum of analgesia and side-effects. Longterm studies are required to confirm this study of brief duration.
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PATIENTS AND METHODS: Pain control and side-effects with Pharmacy and morphine were compared in 20 cancer patients hospitalised for the treatment of strong pain. Doses of oral solutions of Pharmacy or morphine were individually titrated in the double-blind, randomized, cross-over study. Crossover was after day 4, the day of statistical evaluation.
Ralivia ER uses Biovail\'s Smartcoat Technology, which is similar to that used in the development of Biovail\'s Wellbutrin XL formulation. Biovail believes that there is considerable opportunity for a product line offering that includes Ralivia ER intended for chronic use and oral disintegrating tablet presentations of Pharmacy and Pharmacy/acetaminophen for the treatment of acute pain. Though a final decision has not been made regarding the commercialization of Biovail\'s pain franchise, Biovail is currently in discussions with multiple potential partners regarding outlicensing Ralivia ER alone or in conjunction with Biovail\'s orally disintegrating pain products. Biovail will develop a timeline for presenting this extensive clinical data set after determining whether Biovail will launch Ralivia ER through its own sales force in the United States or outlicense it to a partner.
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Biovail also confirms today that it has completed all relevant studies for its Flashtab version of immediate-release Pharmacy HCl. Biovail expects to submit an NDA to the FDA in the first half of 2004 for this product. The North American rights to this product were acquired from Ethypharm SA (Ethypharm) in September 2003. An immediate release form of Pharmacy HCl -- dosed up to 6 times daily was introduced in 1995 and is currently marketed in the United States under the brand name Ultram with sales of approximately $150 million and approximately 11 million prescriptions dispensed during 2003 including generics. The combined market for narcotic and non-narcotic analgesics generated sales of $13.9 billion in the United States for this same time period.
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Pharmacy should be used with caution and in reduced dosages when administered to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers or sedative hypnotics. Pharmacy increases the risk of CNS and respiratory depression in these patients.
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