FDA Approves Kowa’s Cambia for Migraines

migraineKowa Pharmaceuticals America announced that the U.S. Food and Drug Administration has approved Cambia for the treatment of acute migraine headaches in adults. Cambia is a diclofenac-based non-steroidal anti-inflammatory drug (NSAID) combined with potassium bicarbonate. In clinical trials, Cambia not only treated migraine pain, but also the associated symptoms of sensitivity to light, sensitivity to sound, and nausea. The drug provided statistically significant onset of relief of migraine pain within 15 to 30 minutes.

Cambia is designed to fill the large, unmet clinical need for a fast-acting migraine treatment. According to the U.S. Department of Health and Human Services, migraine pain and symptoms affect approximately 29.5 million Americans. In a recent peer-reviewed publication authored by migraine researchers, 70 percent of patients indicated they were unsatisfied with their current treatment. Cambia is approved to treat migraines with or without auras. Patients with auras may see flashing lights, feel numbness in the extremities, or experience sensory disturbances. One in five migraine patients experiences an aura.

Alabama-based KPA is owned by the Kowa Company, a multinational company headquartered in Japan. Other companies developing migraine pain treatments include NatureWell, Vernalis Pharmaceuticals, NeuraLieve, POZEN, and Winston Laboratories.