FDA committees approve ALO-02 capsules

Two U.S. Food and Drug Administration’s (FDA) Advisory committees recently recommended extended-release capsules for ALO-02 from Pfizer.

ALO-02 consists of oxycodone hydrochloride and naltrexone hydrochloride and is currently proposed to manage pain that requires long-term opioid treatment or those that need help on a consistent basis. This tablet was designed to mitigate the risks of opioid abuse if it is misused. If the tablet is crushed the naltrexone acts as a counter to the effects of the oxycodone. Naltrexone is an opioid antagonist and in the capsule it is surrounded by the oxycodone, allowing the extended-release function.

“Pfizer believes the ALO-02 data support approval with abuse-deterrent labeling and we look forward to ongoing discussions with the FDA,” Chief Development Officer of Neuroscience and Pain with Pfizer Inc. Ken Verburg said. “Abuse-deterrent opioids are an important part of a multi-faceted approach to help address the growing abuse epidemic.”

The FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted to approve ALO-02 extended-release capsules with a majority of nine votes. The respective committees also voted to include abuse-deterrent labeling for intravenous and intranasal forms of this medication. Abuse-deterrent labeling was not approved for oral tablets.

The FDA will take the committees’ recommendations into consideration before taking action on the New Drug Application for ALO-02.