Teva’s opioid not abuse-deterrent when taken orally: FDA staff

An experimental, long-acting painkiller made by Teva Pharmaceutical Industries Ltd does not have abuse-resistant properties when taken orally, according to a preliminary review by the U.S. Food and Drug Administration.

The drug, whose proposed trade name is Vantrela ER, did demonstrate resistance to abuse by those seeking to inhale or inject it, the review said.

The review was published on the agency’s website on Friday and comes ahead of a June 7 meeting of outside experts. They will discuss the drug and recommend whether it should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

The panel is being asked to decide whether Vantrela ER should be allowed to claim on its label that it deters abuse. The panel will vote separately on whether it likely deters abuse when swallowed, snorted or injected.

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 agency’s review found that the drug was effective and did not raise any new safety concerns.

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 an opioid overdose.

On Thursday officials confirmed that the musician Prince died from 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 Inc. estimate Vantrela ER could generate annual sales of $130 million by 2020. The drug would compete with Purdue Pharma’s once-daily Hysingla ER and Pernix Therapeutics LLC’s Zohydro ER.

The panel’s discussion comes amid increasing political pressure on the FDA to address the problem of opioid abuse. Earlier this year, after a number of senators threatened to block his nomination as FDA commissioner, Dr. Robert Califf said the agency would reform its process for approving opioids.

In March the FDA announced that short-acting opioids would carry new warnings about the potential for abuse, bringing the labels in line with the warnings on long-acting pills.

On Wednesday the same panel will consider an abuse-resistant painkiller made by Pfizer Inc that combines oxycodone hydrochloride with naltrexone hydrochloride.

(Reporting by Toni Clarke in Washington; Editing by Chris Reese and Cynthia Osterman)

comments powered by Disqus