FDA rules benzhydrocodone and acetaminophen (Adapaz) application not ready for approval yet.
The FDA has rejected KemPharm Inc’s benzhydrocodone and acetaminophen (Adapaz), a potential abuse-deterrent treatment for acute pain.
KemPharm Inc received a complete response letter that stated the application was not ready for approval in its present form, and the letter offered guidance on the deficiencies the administration found.
“After last week’s amendment request, a complete response letter from the FDA was received for the Apadaz NDA [new drug application],” said Travis C. Mickle, PhD, president and CEO of KemPharm, in a press release. “We are currently evaluating the points raised in the CRL [complete response letter] and intend to request an end of review meeting with the agency to determine the pathway forward for Apadaz.”
The Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA met back in May 2016 to review and vote on Apadaz. By a vote of 16 to 4, the committee decided that Apadaz should be approved for its proposed indication. However, the committee voted 18 to 2 against the inclusion of abuse-deterrent labeling.
“We continue to believe in the value of our prodrug technology as a platform for developing prescription opioids with abuse-deterrent properties,” said Dr. Mickle, at the time of the meeting.