FDA Panels Back Apadaz Approval, Reject Abuse-Deterrent Label

Two FDA advisory committees recommended the FDA approve KemPharm’s opioid pill Apadaz, even though they rejected an abuse-deterrent label for the candidate.

The candidate, a combination of benzhydrocodone and acetaminophen, was backed 16-4 last week by the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

However, the product did not fare as well when the question turned to whether it qualifies as abuse deterrent, with the committees recommending 2-18 that the FDA not approve the designation. Panelists were not convinced by a study KemPharm performed that showed slightly reduced levels of potency when the pill is crushed, which many abusers do to snort the drug.