(Reuters) - A long-acting opioid painkiller being developed by Pfizer Inc (N:PFE) has the potential to deter abuse but can be manipulated, a preliminary review by the U.S. Food and Drug Administration showed.
The drug is designed 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 treatment, whose proposed trade name is Troxyca ER, contains commonly used opioid, oxycodone. The abuse deterrence mechanism relies on the incorporation of naltrexone in the drug pellets. (http://1.usa.gov/1UCIQUI)
Troxyca ER is designed such that if the pellets are crushed in an attempt to abuse the painkiller, naltrexone is released to counteract the effects of oxycodone.
The panel is being asked to decide whether the drugmaker should be allowed to claim on the drug's label that it deters abuse. The panel will vote separately on whether it likely deters abuse when swallowed, snorted or injected.
FDA reviewers said in a report published on Monday that oxycodone could be selectively extracted from intact pellets by a number of straightforward techniques and certain common solvents appear to be capable of removing naltrexone from crushed pellets.
However, studies did demonstrate that negligible oxycodone is released from heated Troxyca ER vapor, reducing the likelihood of abuse by those seeking to inhale it, the reviewers added.
The review comes ahead of a June 8 meeting of outside experts, who will recommend whether the drug should be approved. The FDA is not obliged to follow the advice of its advisory panels but typically does.
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.
There is increasing political pressure on the FDA to address the problem of opioid abuse.
Earlier this year, FDA Commissioner Robert Califf said the agency would reform its process for approving opioids after a number of senators threatened to block his nomination as the agency's head.
The CDC recommended in March that doctors prescribe non-opioids, including acetaminophen and ibuprofen, for patients with pain unless they have active cancer or are receiving end-of-life care.
The FDA also 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.