Teva Pharmaceutical Industries has announced that the Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 14 to 3 to recommend approval of VANTRELA™ ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. VANTRELA ER is an extended-release formulation of hydrocodone bitartrate with Teva’s proprietary abuse deterrence technology.
The committees also voted:
- 14 to 3 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the oral route of abuse.
- 14 to 3 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the nasal route of abuse.
- 16 to 1 that if approved, VANTRELA ER should be labeled as an abuse-deterrent product by the intravenous route of abuse.
“There remains a need for treatment options that help deter potential abuse while still providing people living with pain access to effective relief options,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are encouraged by the outcome of today’s FDA Advisory Committee meeting and support for labeling as an abuse-deterrent product by the oral, nasal and intravenous routes of abuse. We believe in the potential of both VANTRELA ER and our proprietary abuse deterrence technology.”
Based on the committees’ votes, Teva anticipates, if approved, the label for VANTRELA ER will describe the product’s abuse-deterrent properties that are expected to reduce, but not totally prevent, abuse of the drug when the tablets are manipulated. The FDA is not bound by the recommendations of its advisory committees, but will consider their guidance during the review of the New Drug Application (NDA) for VANTRELA ER.
Adverse events reported in five percent or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included: nausea, constipation, vomiting, headache, somnolence, itching and dizziness.