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FDA approves novel form of addiction treatment: A 6-month implant

With effective therapy for opioid addiction in short supply, the Food and Drug Administration on Thursday approved a new option that is both groundbreaking and familiar.

Probuphine — four inch-long rods implanted inside the upper arm — will be the longest-acting therapy on the market.
Probuphine — four inch-long rods implanted inside the upper arm — will be the longest-acting therapy on the market.Read moreBraeburn Pharmaceuticals

With effective therapy for opioid addiction in short supply, the Food and Drug Administration on Thursday approved a new option that is both groundbreaking and familiar.

Probuphine, a six-month implant the size of a matchstick, will be the longest-acting therapy on the market. The medication that it dispenses, buprenorphine, is one of the most common for addiction to pain pills and heroin, currently available only in daily doses.

The new formulation, from Braeburn Pharmaceuticals, a small, Princeton-based company, is intended for people in stable, long-term recovery who have been on low amounts of the oral medication for at least six months.

The company said it would move quickly to manufacture Probuphine and expected to begin shipments within a few weeks. Braeburn plans to build a plant in Durham, N.C.; meanwhile, production is being outsourced to a company in Texas, with packaging by Sharp Packaging Services in Allentown.

Michael Frost, an addiction specialist whose private practice in Conshohocken was one of 23 sites nationwide for the most recent clinical trial, said the implant allowed patients to "start focusing less on my medication and more on other parts of my recovery, personal relationships, going back to school."

Kyle Kampman, a psychiatry professor at the University of Pennsylvania who oversaw another site, said a major advantage was avoiding the daily choice of continuing treatment or getting high. The implanted drug, which contains enough opioid to keep users from going into withdrawal, cannot be diverted for street sales, he said.

Critics have dismissed it as no better than what is available now, usually sold as Suboxone.

The FDA rejected the implant in 2013, mainly for a lack of evidence of its effectiveness. The latest clinical trial was limited to patients already stable in recovery. Those data led an advisory committee in January to vote 12-5 for approval, saying the implant was about as effective as the oral version.

Behshad Sheldon, Braeburn's president and CEO, said in an interview shortly before Thursday's approval that the implant had significant advantages over current versions of the drug. A key one is overdose protection.

Maintenance buprenorphine allows patients to do the long-term behavioral work that is necessary to sustain recovery.

But the temptation to skip a daily dose and do heroin one more time remains even as the body's tolerance declines, creating conditions for an overdose.

"You don't know if a year from now, they are going to break up with a boyfriend and then slip and make a mistake and then die," Sheldon said.

More than 28,000 Americans died of opioid overdoses - prescription painkillers or heroin - in 2014, according to the latest federal data. The vast majority were not in treatment at the time, but the period immediately following abstinence - typically release from prison or rehab - is known to be high risk.

"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 that can help patients regain control over their lives," FDA Commissioner Robert M. Califf said in a statement Thursday. "Today's approval provides the first-ever implantable option to support patients' efforts to maintain treatment as part of their overall recovery program."

The FDA said Probuphine should be used as part of a complete treatment program that includes counseling and psychosocial support.

Braeburn, which is financed largely by the New York-based venture fund Apple Tree Partners, has weekly and monthly injections of buprenorphine in clinical trials.

Probuphine, which uses new technology licensed from Titan Pharmaceuticals of San Francisco, consists of four one-inch-long rods that are implanted under the skin on the inside of the upper arm, providing slow release for six months. It is pronounced Pro-BYOO-feen, for "providing buprenorphine."

There are three main types of medication-assisted treatment, all shown to be more effective than 12-step and other abstinence-based programs.

Naltrexone works by blocking the effects of opioids; patients must be completely free of the opioids before starting or they will experience withdrawal.

Methadone is a replacement opioid but is more powerful than buprenorphine and is dispensed daily under tight controls at clinics. Specially trained physicians can write prescriptions for buprenorphine, but can treat no more than 100 patients.

Buprenorphine is most commonly sold in a tamperproof version called Suboxone that must be dissolved under the tongue. It contains a small dose of naloxone, the emergency overdose-reversal medication. The naloxone is released only if the drug is crushed and abused, sending the body into withdrawal.

About 1.3 million Americans take some daily form of buprenorphine; Braeburn estimates at least one quarter meet the criteria for the implant.

The company has not announced pricing but said it would be "lower than other long-acting medications currently on the market." That could mean up to $6,000 for six months.

Sarah Wilson said her doctors prescribed opioid painkillers after a 2008 car accident but balked at the higher doses she required, so she bought them on the street, leading to addiction.

She was successfully treated with buprenorphine but enrolled in an implant clinical trial near her Jacksonville, Fla., home. The effects of her car crash remain. "Yes, the pain is bad," said Wilson, 40, "but mostly I'm just grateful to be here."

dsapatkin@phillynews.com

215-854-2617 @DonSapatkin