KemPharm Receives Complete Response Letter for Acute Pain Candidate

The FDA has rejected KemPharm’s application for its abuse-deterrent, short-term acute pain management candidate Apadaz.

Company President and CEO Travis Mickle said the clinical-stage drugmaker is evaluating the points raised in the agency’s complete response letter and that it intends to request a meeting with the agency to determine the next steps.

Company spokesman Jim Heins declined further comment.