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Article for: KMPH
CORALVILLE, Iowa, May 05, 2016 (GLOBE NEWSWIRE) — KemPharm, Inc. (KMPH), a clinical-stage specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) reviewed and voted on Apadaz™ (benzhydrocodone hydrochloride and acetaminophen), KemPharm’s investigational abuse-deterrent product candidate for the short-term management of acute pain.
The Committee determined by a vote of 16 to 4 in that Apadaz should be approved for its proposed indication of the management of acute pain that requires an opioid and voted 18 to 2 against inclusion of abuse deterrent labeling for the product.
“We continue to believe in the value of our prodrug technology as a platform for developing prescription opioids with abuse-deterrent properties,” said Travis C. Mickle, Ph.D., President and CEO of KemPharm. “While it is inevitable that there will be different points of view when evaluating new molecular entities with abuse-deterrent properties, we will continue to work collaboratively with the FDA to complete the review process of Apadaz.”
Apadaz is an abuse-deterrent, immediate release (IR) fixed-dose combination product candidate composed of benzhydrocodone hydrochloride (HCl), a prodrug of hydrocodone and benzoic acid, and acetaminophen (APAP). The FDA will consider, but is not bound by, the advisory committees’ recommendations as it continues its review of Apadaz. A target action date of June 9, 2016, has been set by the FDA under the Prescription Drug User Fee Act (PDUFA).
KemPharm is a clinical-stage specialty pharmaceutical company focused on the discovery and development of prodrugs to treat serious medical conditions through its Ligand Activated Therapy (LAT) platform technology. KemPharm utilizes its LAT platform technology to generate improved prodrug versions of FDA-approved drugs in the high need areas of pain, ADHD and other CNS disorders.
Source – Company Press Release
Broad street alerts has not been compensated for the mention of any publicly traded companies in this article nor do we own positions in any of the companies in this article.
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