KemPharm Inc (NASDAQ:KMPH) reported that the U.S. FDA permitted its New Drug Application for Apadaz™ for the short-term management of acute pain grave enough to need an opioid analgesic and for which other treatments are inadequate. As per the update, Apadaz marks as an immediate release combination of company’s prodrug, acetaminophen and benzhydrocodone.
Travis Mickle, Ph.D., the CEO and President of KemPharm, expressed that the approval of Apadaz marks as an important milestone for company as it creates the prospect to launch what they consider is a differentiated item for the short-term treatment of acute pain. Depending on its innovative properties, they firmly consider there is a commercial course for Apadaz in what marks as an extremely high-volume industry. They are thrilled by the prospect Apadaz provides to patients and for doctors who now have the alternative of prescribing a distinguished product.
Dr. Mickle added that besides today’s approval, the U.S. DEA has suggested that it is their plan to schedule Apadaz as a C-2 product and will offer an allocation of the API consistent with the scheduling provisions. This prompt conclusion by the DEA essentially closes the regulatory procedure with both Agencies and enables them to shift their focus towards the product release.
The CEO of KemPharm expressed that it marks as a validation of company’s groundbreaking LATTM platform and their technological approach to drug advancement. KemPharm is a prodrug development firm. The Apadaz approval showcases the value prospect that LAT™ provides in the development and discovery of proprietary prodrugs that are intended to be differentiated forms of widely prescribed, presently permitted drugs, and that can successfully close the rigorous regulatory procedure.
In the last trading session, the stock price of gained more than 1% to close the day at $5.95. The gains came at a share volume of 197,354 compared to average share volume of 222,212.