Kowa Pharmaceuticals America, Inc, (KPA) a privately-held specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Cambia, a diclofenac-based non-steroidal anti-inflammatory drug (NSAID) combined with potassium bicarbonate, for the treatment of acute migraine with or without aura in adults.

Cambia, formulated with KPA's patented Dynamic Buffering Technology (DBT), was specifically developed to address widespread unmet needs among patients by offering fast and effective relief of migraine pain. In randomized clinical trials, Cambia was shown to be effective not only in migraine pain, but also in treating photophobia (sensitivity to light), phonophobia (sensitivity to sound), and nausea commonly associated with migraine attacks. Cambia was also shown to provide statistically significant onset of relief of migraine pain within 15 to 30 minutes.

"The approval is the culmination of over three years of effort from our partners at Applied Pharma Research (APR) and the internal team at Kowa," said William Maichle, chief operating officer of Kowa Pharmaceuticals America, Inc. "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 obtained exclusive US and Canadian marketing rights for Cambia from Applied Pharma Research (APR), a Swiss drug delivery and drug development company, in 2005. The product is currently marketed by Novartis Pharma AG, via a license from APR, under the trademarks Voltfast or Catafast in several European countries. KPA and APR have been granted patents that cover Cambia through 2026. KPA and APR are currently in the final stages of negotiations with a marketing partner and expect Cambia to launch in fourth quarter 2009.

Kowa Company is a privately held multinational company headquartered in Nagoya, Japan. Established in 1894, Kowa is actively engaged in various manufacturing and trading activities in the fields of pharmaceutical, life science, information technology, textiles, machinery and various consumer products.

APR is an independent, international, vertically integrated drug delivery and drug development company in healthcare with registered offices in Switzerland and the US.