The FDA approved KemPharm, Inc.’s New Drug Application (NDA) for Apadaz for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Apadaz is an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP).
“The approval of Apadaz is a significant milestone for KemPharm as it creates the opportunity to introduce what we believe is a differentiated product for the short-term management of acute pain,” said Travis Mickle, Ph.D., KemPharm president and chief executive officer. “Based on its unique properties, we firmly believe there is a commercial pathway for Apadaz in what is a very high-volume market.”
Mickle added that the U.S. Drug Enforcement Administration has indicated intent to schedule Apadaz as a C-II product and provide an allocation of the active pharmaceutical ingredient, essentially completing the regulatory process with both agencies and allowing KenPharm to shift its focus towards the product launch.
(Source: KemPharm, Inc.)
Filed Under: Drug Discovery
