Published June 08, 2016
A U.S. advisory panel recommended approving Teva Pharmaceutical Industries Ltd's long-acting opioid painkiller, Vantrela ER, saying data showed it 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 will reduce, though not necessarily prevent, abuse through swallowing, snorting or injecting.
A preliminary FDA review issued on Friday concluded Vantrela ER had properties deterring abuse through snorting or injecting, but the abuse-resistant benefit was less clear when the product was swallowed.
Most panelists on Tuesday noted the drug's abuse-deterrent properties were relatively small, but agreed that there was room 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," said the panel's chair, Dr Raeford Brown Jr, a professor of anesthesiology and pediatrics at the University of Kentucky.
The FDA is not obliged to follow the advice of its expert panels but typically does so.
The panel's discussion comes amid a broader national discussion about how to curb opioid abuse while ensuring the availability of opioids for patients in chronic pain.
The FDA's approval for 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.
On Tuesday, some panelists echoed that concern.
"I'm really concerned about the number of very high dose opioids on the market, and this is just another high-dose drug," said Dr Jeanmarie Perrone, professor of emergency medicine at the University of Pennsylvania.
The drug 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 an accidental overdose of the synthetic opioid fentanyl. Teva's drug contains the commonly used opioid hydrocodone.
Mizuho Securities USA analysts estimate Vantrela ER could generate annual sales of $130 million by 2020, and compete with Purdue Pharma LP's once-daily Hysingla ER and Pernix Therapeutics LLC's Zohydro ER.
On Wednesday, the panel will discuss Pfizer Inc's long-acting opioid painkiller.