KemPharm, Inc. (NASDAQ:KMPH) announced that a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration (FDA) has been scheduled for May 5, 2016, to review KemPharm’s New Drug Application (NDA) for KP201/APAP, its lead investigational drug candidate for the short-term management of acute pain.
According to the news:
KP201/APAP is a combination of KP201, KemPharm’s prodrug of hydrocodone (benzhydrocodone hydrochloride), and acetaminophen (APAP), which is being developed as an abuse-deterrent immediate release prodrug of hydrocodone bitartrate/APAP. The Company’s NDA for KP201/APAP was accepted and granted priority review by the FDA in early February 2016. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 9, 2016.
Travis C. Mickle, Ph.D., President and CEO of KemPharm stated:
The Advisory Committee meeting is an important step forward in the review process for KP201/APAP. We look forward to discussing the data submitted as part of our NDA filing with the Advisory Committee members and continuing to work with the FDA through the review process.
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