FDA Approves New "Abuse-Deterrent" Oxycodone — Physician’s First Watch

Medical News |
July 25, 2014

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."

Reader Comments (1)

JAMES RECHT Physician, Psychiatry, Community Clinic

Another distressing example of what happens when we put profits before people. This is a stupid drug. It serves no purpose other than to generate income for those who sell it. It will be marketed as safer than oxycodone. It's not. Now let's be clear. This stupid and dangerous new drug will not cause iatrogenic addiction because fools try to inject or snort it, no. Instead, it will cause iatrogenic addiction because individuals suffering from pain (and depression and anxiety and life problems) will become addicted to it via the oral route. Because they and their doctors will believe (or tell themselves) that it's "abuse deterrent." Then, when their physical dependence has worsened to the point at which stronger opiates are required, they will find heroin, because heroin is (and remains) everywhere. Are we going to get real about treating addiction, people? Or are we going to keep dispensing this lethal nonsense? Clinicians have a choice to make here.

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