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WYETH-AYERST ORUVAIL ONCE-A-DAY KETOPROFEN NOVEMBER AVAILABILITY

Executive Summary

WYETH-AYERST ORUVAIL ONCE-A-DAY KETOPROFEN NOVEMBER AVAILABILITY is planned following the drug's Sept. 24 approval for management of arthritis symptoms, Wyeth-Ayerst said. Oruvail is an extended-release formulation of the company's nonsteroidal anti- inflammatory drug Orudis (ketoprofen). The NDA (19-816) was filed Dec. 28, 1987 and resubmitted Nov. 4, 1988. The 200 mg once-a-day Oruvail capsules represent "the first nonsteroidal anti-inflammatory drug in an extended-release, once- a-day, pH-dependent dosage form," Wyeth-Ayerst declared. Labeling states that each Oruvail capsule "contains ketoprofen in the form of hundreds of coated pellets. The dissolution of the pellets is pH dependent with optimum dissolution occurring at pH 6.5-7.5. There is no dissolution at pH 1." The drug's dissolution profile suggests that "the administration of antacids or other drugs which may raise stomach pH would not be expected to change the rate or extent of absorption of ketoprofen from Oruvail capsules," labeling states. Oruvail 200 mg can be used in place of the standard Orudis arthritis dose of 50 mg four times a day or 75 mg three times a day, labeling indicates. Oruvail is not recommended for initial dosing in the elderly or in patients with renal or hepatic dysfunction. "Using standard assessments of therapeutic response, there were no detectable differences in effectiveness or in the incidence of adverse events in crossover comparison of Orudis and Oruvail," labeling states. Wyeth-Ayerst's Oruvail database includes 622 treated patients in trials lasting from four to 16 weeks, labeling states. "The use of Oruvail in patients with acute pain is not recommended, since, in comparison to Orudis, Oruvail would be expected to have a delayed analgesic response due to its controlled-release characteristics," labeling states. Wyeth-Ayerst has not disclosed pricing for Oruvail. Four Orudis 50 mg tabs list for $3.17 (direct price) and three 75 mg tabs cost $2.64, according to the Medi-Span prescription pricing guide. Orudis' price was not affected by a Sept. 9 round of price increases for Wyeth-Ayerst, according to Medi-Span. Oruvail's approval comes over two years after the expiration of the Orudis patent in February 1991. However, generic competition to Orudis began only in January with the introduction of Biocraft's ketoprofen ("The Pink Sheet" Jan. 4, T&G-6). Lederle received a ketoprofen ANDA approval in February. Orudis sales in 1991 were $125 mil. ("The Pink Sheet" April 13, 1992, p. 9). Wyeth-Ayerst apparently plans to position Oruvail as a new entrant into the arthritis market rather than promoting it exclusively as a successor product to Orudis. Initial press materials describe the drug as "the newest treatment for arthritis" and point out that it has been "marketed in the United Kingdom for more than 10 years and is currently available in 40 other countries." The materials do not mention Orudis. Wyeth-Ayerst's initial package insert describes Oruvail as "controlled-release" capsules. In keeping with FDA's efforts to adopt uniform USP terminology, the agency's approval letter directs Wyeth-Ayerst to change the language to "extended-release" capsules "at the next printing or within six months of the date of this letter, whichever is sooner."
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