logo
  

FDA Panel Fails To Back Abuse-deterrent Properties Of KemPharm's Pain Pill

The FDA panel vote on KemPharm Inc's (KMPH) Apadaz, an investigational abuse-deterrent product candidate for the short-term management of acute pain, has come as a dampener for the company.

The FDA panel voted 16 to 4 recommending that Apadaz should be approved for its proposed indication of the management of acute pain that requires an opioid and voted 18 to 2 against inclusion of abuse deterrent labeling for the product.

The FDA's final decision is set for June 9, 2016.

Commenting on the FDA panel's recommendation, Travis Mickle, President and CEO of KemPharm said, "While it is inevitable that there will be different points of view when evaluating new molecular entities with abuse-deterrent properties, we will continue to work collaboratively with the FDA to complete the review process of Apadaz.

Trading of KMPH was halted during the day on Thursday ahead of the FDA panel review. In after-hours, the stock plunged 57.56% to $6.65.

For comments and feedback contact: editorial@rttnews.com

Follow RTT