Regulatory Affairs

FDA approves KemPharm’s Apadaz for short-term pain management

PBR Staff Writer Published 26 February 2018

KemPharm has secured approval from the US Food and Drug Administration (FDA) for its opioid painkiller, Apadaz, for the short-term management of acute pain.

The approval is for pain management with Apadaz for no more than 14 days, in patients whose pain is severe enough to need an opioid analgesic, for which alternative treatments are not commonly available.

Apadaz is now the first prodrug of Hydrocodone/Acetaminophen to bag an FDA approval.

The opioid painkiller is an immediate release (IR) combination of KemPharm’s prodrug, benzhydrocodone, and acetaminophen (APAP). 

KemPharm president and CEO Travis Mickle said: “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.”

Apadaz has been developed based on KemPharm’s LAT (Ligand Activated Therapy) prodrug platform. The LAT technology is used by KemPharm to discover and develop prodrugs that are new molecules developed to enhance one or more of the attributes of approved drugs, including susceptibility to abuse, bioavailability and safety.

KemPharm said prodrugs when administered are separated from the ligand by targeted human metabolic processes like those in the GI tract. Through this functionality, the parent drug is released, thereby applying its therapeutic effect.

The company failed to get an approval for Apadaz in 2016 on grounds of possible intranasal abuse, but found success after resubmitting the drug’s New Drug Application (NDA) for review in September 2016.

Mickle added: “In addition to today’s approval, the U.S. Drug Enforcement Administration (DEA) has indicated that it is their intent to schedule Apadaz as a C-II product and will provide an allocation of the Active Pharmaceutical Ingredient (API) consistent with those scheduling provisions. 

“This prompt decision by the DEA essentially completes the regulatory process with both Agencies and allows us to shift our focus towards the product launch.”


Image: FDA Building 51 in Silver Spring, Maryland which houses the Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration/Wikipedia.org.