An experimental, long-acting opioid painkiller from Pfizer Inc showed potential to deter abuse but can be manipulated, according to a preliminary review by the U.S. Food and Drug Administration.
The treatment, whose proposed trade name is Troxyca ER, contains commonly used opioid, oxycodone. The abuse deterrence mechanism relies on incorporation of naltrexone into the drug product pellets. (http://1.usa.gov/1UCIQUI)
The drug 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.
Oxycodone can be selectively extracted from intact pellets by a number of straightforward techniques and certain common solvents appear to be capable of removing naltrexone selectively from crushed pellets, the review said.
The review was published on the agency's website on Monday and comes ahead of a June 8 meeting of outside experts, who 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.