SYNTEX/P&G OTC NAPROXEN CLINICAL STUDIES IN PROGRESS
SYNTEX/P&G OTC NAPROXEN CLINICAL STUDIES IN PROGRESS, the two firms noted in a release announcing the Sept. 19 signing of a definitive joint venture agreement. "Additional studies required to gain marketing approval [for OTC naproxen] are under way," the companies said. The agreement establishes a 50-50 joint venture company to market an OTC formulation of naproxen and other OTC drugs for pain and inflammation. The joint venture agreement also includes P&G's OTC acetaminophen/phenyltoloxamine product, Percogesic, which is marketed by the firm's Rich-Vicks subsidiary. Called Procter-Syntex Health Products Company, the joint venture will operate out of Rich-Vicks' facilities in Wilton, Connecticut. The company will be managed by a committee consisting of an equal number of representatives from Syntex and Procter & Gamble. In March, when the agreement-in-principle was first announced, the firms noted that Syntex had been meeting with FDA to discuss the type of studies necessary for an OTC formulation of the nonsteroidal anti-inflammatory agent naproxen. Syntex indicated that one aim of the clinical program would be to identify the appropriate strength for an OTC product. Upjohn and Boots, in seeking approval for an OTC strength of ibuprofen, conducted studies with a strength that was half the lowest approved dosage. Syntex' prescription brand of naproxen, Naprosyn, is marketed in 250, 375 and 500 mg. tablets. In addition, P&G and Syntex noted that "separate agreements have also been signed which may lead to further collaboration on prescription drug products and/or additional OTC products," most likely in the pain and inflammation areas. Syntex indicated that the agreements provided for potential future collaboration on agents currently in the early research stages.
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth