FDA approves Pfizer’s abuse-deterrent opioid painkiller
Pfizer has announced that the US FDA has approved Troxyca ER (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Troxyca becomes the first and only oxycodone with oral-abuse deterrent features described in the labelling. The medicine has properties that are expected to reduce abuse when crushed and administered by the oral and intranasal routes.
The extended-release capsules contain pellets that consist of opioid agonist, oxycodone hydrochloride, which surround opioid antagonist, naltrexone hydrochloride. Pfizer indicates that studies have shown that when the pellets are crushed, the sequestered naltrexone is released and is available to counteract the effects of oxycodone.
Rory O’Connor, chief medical officer of internal medicine, at Pfizer, says: “Public health authorities and regulators have encouraged the development of treatments that are more difficult to abuse, yet offer pain relief to appropriate patients when used as indicated. The development of this medication with abuse-deterrent properties is another example of our ongoing commitment to advancing science and the treatment of patients with pain condition.”
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