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FDA gives green light for opioid addiction implant

Titan and Braeburn's Probuphine is first implant of its kind to win US approval
Opioid addiction

The first implant treatment for opioid dependence will be launched in the US shortly following FDA approval for Titan Pharma and Braeburn Pharma's Probuphine.

The biannually administered implant provides a constant, low-level dose of buprenorphine, and is intended for use as part of a maintenance treatment programme for patients already stable on low-to-moderate doses of the drug in other forms.

Probuphine is designed to provide some of the euphoric effects of drugs like heroin, and so minimise withdrawal symptoms and the highs and lows associated with opioid misuse.

An estimated 26.4 - 36 million people suffer from opioid use disorder worldwide, with approximately 2.1 million addicted to prescription opioid pain relievers and a further 467,000 hooked on heroin in the US alone.

Probuphine is the first time that an opioid implant has been given a US license, having been recommended for approval by an FDA panel earlier this year after its manufacturers provided further safety information on its insertion and removal.

The drug provides a new long-acting treatment option for patients with opioid use disorder who previously had to rely on daily doses of pills or dissolvable films - a method vulnerable to the resale of prescribed doses.

Commenting on the approval, FDA commissioner Robert Califf said that such an innovative therapy will help patients to regain control over their lives.

He added: “Opioid abuse and addiction have taken a devastating toll on American families. We must do everything we can to make new, innovative treatment options available.”

Probuphine's approval was based on the results of a randomised clinical trial of adults under the age of 65 with a stable opioid dependence.

It found that 63% of patients treated with the Probuphine implant had no evidence of illicit opioid use throughout the six months of treatment.

Nora Volkow, director of the National Institute on Drug Abuse, said: “Scientific evidence suggests that maintenance treatment with these medications in the context of behavioural treatment and recovery support are more effective in the treatment of opioid use disorder than short-term detoxification programmes aimed at abstinence.

“This product will expand the treatment alternatives available to people suffering from an opioid use disorder.”

Article by
Rebecca Clifford

27th May 2016

From: Regulatory

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