Biopharmaceutical company Horizon Pharma Inc. has modified the Duexis (ibuprofen/famotidine) Marketing Authorization Application (MAA) submission to the National Procedure in the United Kingdom to include the recently approved Valeant Pharmaceuticals manufacturing site in Laval, Quebec (previously owned and operated by sanofi-aventis), which is used as the primary site to manufacture Duexis for the United States market.
The MAA was originally submitted through the Decentralized Procedure in October 2010 with the United Kingdom as the Reference Member State, and subsequently withdrawn so that it could be updated by incorporating principally the approved manufacturing site in Canada to streamline the review process and avoid a post-approval variation. Horizon Pharma anticipates a decision on the updated MAA in the second half of 2012. Duexis is approved and currently available in the United States.
Duexis, a proprietary single-tablet combination of the NSAID ibuprofen and the histamine H2-receptor antagonist famotidine, is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers, which in the clinical trials was defined as a gastric and/or duodenal ulcer, in patients who are taking ibuprofen for those indications. The clinical trials primarily enrolled patients less than 65 years of age without a prior history of gastrointestinal ulcer. Controlled trials do not extend beyond 6 months.
Horizon Pharma, Inc. is a biopharmaceutical company that is developing and commercializing innovative medicines to target unmet therapeutic needs in arthritis, pain and inflammatory diseases.