FDA Approves New "Abuse-Deterrent" Oxycodone

By Kristin J. Kelley

The FDA has approved a new abuse-deterrent treatment for severe pain — oxycodone hydrochloride and naloxone hydrochloride extended-release tablets marketed as Targiniq ER.

Approval was based on data from a clinical trial of some 600 patients with chronic low back pain, in addition to in vitro and in vivo abuse liability studies. Postmarketing studies will be done to assess the risks for abuse, addiction, hyperalgesia, and overdose with long-term use (over 12 weeks). Nausea and vomiting are the most common side effects.

The opioid analgesic deters abuse via injection and snorting, but it doesn't completely prevent it. Naloxone, which is used to treat opioid overdose, blocks the euphoric qualities of Targiniq ER when crushed. The drug can still be abused when taken orally.

Due to Targiniq ER's abuse potential, the FDA says, "it should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated or would be otherwise inadequate to provide sufficient pain management."