The US Food and Drug Administration (FDA) has approved an oral, abuse-deterrent, extended-release (ER) formulation of oxycodone hydrochloride and naltrexone hydrochloride (Troxyca ER) for severe pain when other treatment options are not successful or tolerated, according to an announcement from Pfizer.

The capsules, previously known as ALO-02, consist of an ER oxycodone “pellet” that surrounds a naltrexone core. If the medication is crushed, the naltrexone can counteract the oxycodone’s effects.

The official indication is 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.”

It is contraindicated for patients with significant respiratory depression, gastrointestinal obstruction, and severe bronchial asthma in certain situations. The most commonly reported adverse events have included nausea, constipation, and vomiting.

Although the drug was designed to deter abuse, the manufacturer noted in a press release that the product can’t eliminate abuse altogether.

Still, “it is the only oxycodone with oral abuse-deterrent features described in the labeling,” the company notes.

“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,” Rory O’Connor, MD, chief medical officer of internal medicine at Pfizer, said in the release.

Panel Recommendations

Back in June of this year, at a joint meeting of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and its Drug Safety and Risk Management Advisory Committee (DSaRM), panelists voted 9 to 6 for recommending that ALO-02/Troxyca ER be approved.
They also voted 9 to 6 that abuse-deterrent labeling should be included regarding intravenous abuse routes and voted 11 to 4 for labeling about intranasal routes. However, the vote was only 6 to 9 regarding oral route labeling.

Earlier this month, as reported by Medscape Medical News, the AADPAC and DSaRM voted overwhelmingly (18 to 1) for recommending approval of the abuse-deterrent morphine product known as Arymo ER (Egalet Corp) for the same indication.

That hard, dense tablet was designed to make chewing or crushing difficult. In addition, it turns to gel when combined with a liquid to deter injection. At its meeting, the joint panel voted 18 to 1 that Arymo ER should have abuse-deterrent labeling for nasal and intravenous routes and voted 16 to 3 that it should also mention oral abuse deterrence.

A final decision by the FDA for that product is expected in October.