FDA approves a new painkiller
The FDA has OK'd a new Purdue Pharma painkiller—Targiniq ER, which combines the prescription opioid oxycodone and overdose treatment naloxone. The Los Angeles Times explains that naloxone is in the mix to “block the euphoric effects of oxycodone and thus make it less enticing to new addicts.”
Rising prescription opioid abuse has become a major social concern, and lawmakers have gone so far as to ask the FDA to rescind its approval of the painkiller Zohydro, made by Zogenix, because it is easy to abuse.
The FDA notes in its approval that Purdue's latest entry “has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection” and that the drug “can still be abused, including when taken orally... which is currently the most common way oxycodone is abused.”
The LAT points out that this is of particular note because naloxone doesn't work as a buzz kill when the drug is swallowed—it is activated only when the pill is crushed.
Deputy Center Director for Regulatory Programs in the FDA's Center for Drug Evaluation and Research, Douglas Throckmorton, notes in a post on the FDA's Voice blog, “we need to remember that ‘abuse-deterrent' is not the same as ‘abuse-proof' and even abuse-deterrent formulations can be abused and people who take them can overdose and die.”
Throckmorton also highlights that deterrence can take various forms, such as Targiniq's naloxone and Purdue's Oxycontin which is designed so it is difficult to crush or dissolve.
He also writes that products with “abuse-deterrent properties are an important step in the right direction, but there is much work to be done.”