FDA Approves New Treatment for Opioid Addiction

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Federal health officials on Thursday approved an innovative new option for Americans struggling with addiction to heroin and painkillers: a drug-oozing implant that curbs craving and withdrawal symptoms for six months at a time.

The first-of-a-kind device, Probuphine, arrives as communities across the U.S. grapple with a wave of addiction tied to opioids, highly-addictive drugs that include legal pain medications like OxyContin and illegal narcotics like heroin. Roughly 2.5 million Americans suffer from addiction disorders related to the drugs, according to federal estimates.

The implant from Braeburn Pharmaceuticals Inc. (Princeton NJ) is essentially a new, long-term delivery system for an established drug, buprenorphine, which has long been used to treat opioid addiction. But its implantable format could help patients avoid dangerous relapses that can occur if they miss a medication dose.

The matchstick-size implant slowly releases a low dose of buprenorphine over six months. Previously the drug was only available as a pill or film that dissolves under the tongue. It is considered a safer, more palatable alternative to methadone, the decades-old standard for controlling opioid addiction.

Probuphine is intended for patients who have already been stabilized on low-to-medium doses of buprenorphine for at least a half year. Braeburn estimates that one fourth, or 325,000, of the 1.3 million patients currently taking buprenorphine meet that criterion. T

The U.S. Food and Drug Administration (FDA) previously rejected Probuphine in 2012, judging the drug’s dose was too low to reliably help the broad range of opioid-addicted patients. Braeburn and partner Titan Pharmaceuticals Inc. (S. San Francisco) resubmitted the product with additional data and it received a positive endorsement from federal advisers earlier this year.

The FDA said Thursday that Probuphine should be used as part of a multipronged addiction treatment program that includes counseling and other forms of support. Doctors who implant the device must also receive special training to safely insert and remove the device.

FDA officials are spotlighting new treatment options for opioid abuse, after weathering heavy criticism for not acting faster to combat the epidemic of addiction and overdose tied to the drugs.

Monday, May 30, 2016 / Vol. 24 / No. 21

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