KemPharm Defends Abuse-Deterrence Evidence in Appeal over CRL for Opioid Apadaz

KemPharm has appealed the FDA’s complete response letter for its opioid Apadaz, contending that the company’s clinical evidence merits an approval with abuse-deterrent claims.

“Apadaz did not meet FDA preferred clinically meaningful endpoints … but we believe it did demonstrate statistically significant differences, compared to an approved non-abuse-deterrent formulation, on measures of abuse deterrence,” Travis C. Mickle, the CEO of KemPharm, said.

The CRL only raised concerns about the company’s clinical evaluation of abuse deterrence, Daniel Cohen, executive vice president of government and public relations for KemPharm said.