A U.S. advisory panel recommended approving Teva Pharmaceuticals Industries Ltd’s long-acting opioid painkiller, Vantrela ER, saying data showed it reduces pain and has some abuse-resistant properties.
The drug is designed for use every 12 hours for the management of pain severe enough to require around-the-clock treatment in patients who have not derived enough benefit from other treatments. The panel recommended 14-3 that the drug be approved and largely supported the claim that the painkiller likely deters abuse if swallowed, snorted or injected.
However, most members noted the drug’s abuse-deterrent properties were relatively small, but agreed that there was a place for incremental improvements over existing painkillers.
“The committee’s belief is that the data presented for all three of these routes of administration do show at least a modicum of abuse deterrence,” Dr. Raeford Brown Jr., the panel’s chair said summarizing its views.
The FDA is not obliged to follow the advice of its expert panels but typically does so.
A preliminary FDA review issued on Friday concluded Vantrela ER had abuse-deterrent properties if snorted or injected, but the abuse-deterrent benefit was less clear when the product was swallowed.
The abuse of opioids – a class of drugs that includes heroin and prescription painkillers – has reached epidemic proportions in the United States. The Centers for Disease Control and Prevention (CDC) estimates that 78 Americans die every day from opioid overdose.
Last month officials in Minnesota determined that death in April of musician Prince was due to an accidental overdose of the synthetic opioid fentanyl. Teva’s drug contains an abuse-resistant form of the commonly used opioid hydrocodone.
Analysts at Mizuho Securities USA estimate Vantrela ER could generate annual sales of $130 million by 2020. The drug would compete with Purdue Pharma LP’s once-daily Hysingla ER and Pernix Therapeutics LLC’s Zohydro ER. The panel will discuss Pfizer Inc’s experimental long-acting opioid painkiller, whose proposed trade name is Troxyca ER.