Migraine medicine gets the OK from FDA

MONTGOMERY, Ala. The Food and Drug Administration has approved Cambia for the treatment of acute migraine with or without aura in adults.

The privately held specialty pharmaceutical company, Kowa Pharmaceuticals America, developed the drug with its patented Dynamic Buffering Technology to provide patients with fast and effective relief for migraine pain. Clinical trials showed Cambia also helped ease photophobia, phonophobia and nausea, all commonly associated with migraine attacks.

“The approval is the culmination of over three years of effort from our partners at Applied Pharma Research and the internal team at Kowa,” said William Maichle, COO of Kowa Pharmaceuticals America. “Patients and physicians consistently mention rapid pain relief as most important when asked about primary attributes of a migraine medication. We believe Cambia addresses these needs and will be a valuable addition to physicians’ migraine armamentarium.”

KPA holds exclusive U.S. and Canadian marketing rights for Cambia from Applied Pharma Research. In conjunction with Novartis Pharma AG, the current European marketer, KPA and APR are in the final stages of negotiations with a marketing partner and anticipate the drug will launch in the fourth quarter 2009.