Pozen Inc. (Nasdaq: POZN) has submitted a Marketing Authorization Application to the Medicines Control Agency in the United Kingdom for MT 100, an oral tablet designed for first-line migraine therapy.
Once approved in the U.K., Pozen says it will seek approval in other European countries through the European Union Mutual Recognition Procedure with the U.K. acting as the Reference Member State. The procedure allows other European countries to grant national approvals based on recognition of the findings of the Medicines Control Agency in the U.K.
“This submission marks an important first step in the evolution of migraine care,” John R. Plachetka, chairman, president, and chief executive officer of Pozen. “The data submitted in this application demonstrates that MT 100’s dual action combination therapy produces excellent therapeutic results. We believe MT 100 may represent the best entry-level therapy for migraine sufferers and may provide a clear alternative to triptans, potent agents that should be reserved for severe migraine attacks.”
Pozen, based in Chapel Hill, has completed all planned Phase III trials for MT 100. The company says the drug has consistently demonstrated its effectiveness in treating migraine pain and associated symptoms with less risk of cardiovascular side effects than leading products on the market today.
Pozen Inc.: www.pozen.com