Pfizer's abuse-resistant painkiller ALO-02 is to be assessed by the US and Food and Drug Administration.
The drug giant is seeking approval for ALO-02 as a potential treatment for pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The misuse of prescription opioids remains a serious and persistent issue in the US; according to the National Survey on Drug Use and Health, nearly 10 million adults in the country reported prescription pain reliever use for non-medical purposes in 2012, highlighting the scope of the problem.
Pfizer is hoping that its drug will go some way to address this - ALO-02 uses technology which should discourage tampering associated with prescription opioid misuse and abuse. It consists of extended-release oxycodone pellets that surround a sequestered core of naltrexone; when the pellets are crushed, the naltrexone is released to counteract the effects of oxycodone.
Data from a Phase III trial in 2012 showed that Pfizer’s drug is as safe as other opioids on the market, the most common side effects being headache, nausea, vomiting and constipation.