US regulators have approved KemPharm’s New Drug Application for Apadaz, offering an alternative to opioids for the short-term management of acute pain.
Apadaz is an immediate release (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, KemPharm President and CEO.
“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.”