The product, which combines benzhydrocodone and acetaminophen, is indicated for the short-term management of acute pain. The FDA rejected KemPharm’s first attempt at regulatory approval for Apadaz in 2016.
Today’s win for KemPharm is also a validation of its prodrug approach, president & CEO Travis Mickle said in prepared remarks.
“KemPharm is first and foremost a prodrug development company,” he said. “The Apadaz approval highlights the value potential that LAT [ligand activated therapy] offers in the discovery and development of proprietary prodrugs that are designed to be differentiated versions of widely prescribed, currently approved drugs, and that can successfully complete the rigorous regulatory process.”
The company’s chief executive also said that the Drug Enforcement Administration plans to classify Apadaz as a Schedule II product, effectively ending KemPharm’s original goal of positioning the product as an abuse-deterrent opioid.
“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. Based on its unique properties, we firmly believe there is a commercial pathway for Apadaz in what is a very high-volume market. We are excited by the opportunity Apadaz offers to patients and for physicians who now have the option of prescribing a differentiated product,” Mickle added.
KMPH shares were trading at $6.60 apiece in mid-afternoon activity today, up 25%.