MT 100
Generic name: metoclopramide hydrochloride and naproxen sodium
Treatment for: Migraine
POZEN's MT 100 To Be Reviewed by Advisory Committee in May 2005
CHAPEL HILL, N.C., --December 21, 2004 - FDA and POZEN Inc. (NASDAQ: POZN) have agreed to present MT 100 to an Advisory Committee for consideration, with particular emphasis on the potential risk of tardive dyskinesia. A tentative date in May has been proposed. This action came as a result of a series of meetings held between the two parties. The FDA stated in a recent memo that it is possible that MT 100 may not be approvable if the benefits of the drug do not, in FDA's opinion, outweigh the risks of MT 100, including the risk of tardive dyskinesia, even if FDA eventually determines that MT 100 meets the efficacy requirements for a combination migraine agent.
MT 100 is a combination of two approved drugs, naproxen sodium and metoclopramide hydrochloride, in a sequential release formulation. POZEN received a not approvable letter from FDA on May 28, 2004 citing a lack of evidence supporting both the efficacy and the safety of the combination product. MT 100 is still under regulatory review in the United Kingdom.
About POZEN
POZEN is a pharmaceutical company committed to developing therapeutic advancements for diseases with unmet medical needs where it can improve efficacy, safety, and/or patient convenience. Since its inception, POZEN has focused its efforts primarily on the development of pharmaceutical products for the treatment of migraine. POZEN is also exploring the development of product candidates in other pain-related therapeutic areas. POZEN has development and commercial alliances with GlaxoSmithKline, Xcel Pharmaceuticals, and Nycomed. The company's common stock is traded on The Nasdaq Stock Market under the symbol "POZN".
For detailed company information, including copies of this and other press releases, see POZEN's website: www.pozen.com.
Posted: December 2004
Related articles
- POZEN Provides Results of FDA Advisory Committee Meeting on MT 100 (Naproxen Sodium and Metoclopramide Hydrochloride) - August 5, 2005
- FDA Sets August 4, 2005 for Advisory Committee Meeting to Consider Tardive Dyskinesia Risk with MT 100 - June 29, 2005
MT 100 (metoclopramide hydrochloride and naproxen sodium) FDA Approval History
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