Pozen Inc. (Nasdaq: POZN) has submitted a New Drug Application (NDA) to the FDA for marketing approval of MT 300 for the acute treatment of migraine headaches.
MT 300 is designed to provide long-lasting pain relief for patients needing a convenient injectable therapy for severe migraine. It is being developed as a new, improved formulation in a convenient pre-filled syringe that is suitable for at-home use.
“I am pleased that we have filed the MT 300 NDA on time and completed a challenging set of goals for 2002, including our earlier submission of a Marketing Authorization Application in the U.K. for our first-line oral migraine therapy, MT 100,” John R. Plachetka, chairman, president, and chief executive officer of Pozen, said in a statement. “Not only is this submission the first step to bringing an alternative, convenient injectable migraine product to many sufferers, but I am particularly proud of our team of dedicated scientists who achieved this milestone for Pozen.”
Based in Chapel Hill, Pozen is a pharmaceutical development company building a portfolio of products with commercial potential in select therapeutic areas. Its initial focus is on developing products for migraine therapy.