FDA Advisors Back Approval of Abuse-Resistant Opioid Painkiller

Vantrela ER would be labeled as an abuse-deterrent product

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and its Drug Safety and Risk Management Advisory Committee have voted 14 to 3 to recommend approval of Vantrela ER (Teva Pharmaceuticals) 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.

Based on the committees’ votes, Teva anticipates that, if Vantrela ER is approved, the label will describe the product’s abuse-deterrent properties, which 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 for Vantrela ER.

Adverse events reported in 5% or more of hydrocodone-treated patients during either the titration or double-blind treatment periods included nausea, constipation, vomiting, headache, somnolence, itching, and dizziness.

The FDA’s approval of drugs it considers effective for treating chronic pain, including cancer pain in children, has been criticized by members of Congress and others who say the last thing the country needs is more-powerful opioids. Some panelists echoed that opinion.

“I'm really concerned about the number of very-high-dose opioids on the market, and this is just another high-dose drug,” Dr. Jeanmarie Perrone, a professor of emergency medicine at the University of Pennsylvania, told Reuters.

Vantrela ER does have some abuse-resistant properties, she added, but patients taking the drug orally “may still feel euphoria just by taking a bigger dose at one time.”

Last week, officials determined that the death of musician Prince in April was due to a self-administered overdose of the synthetic opioid fentanyl. Teva’s drug contains the commonly used opioid hydrocodone.

Sources: Teva Pharmaceuticals; June 7, 2016; and Reuters; June 7, 2016.