FDA Okays Once-Monthly Buprenorphine Shot for Opioid Use Disorder

Megan Brooks

December 01, 2017

The US Food and Drug Administration (FDA) has approved the first and only once-monthly injectable buprenorphine formulation for the treatment of adults with moderate to severe opioid use disorder.

Buprenorphine extended-release (Sublocade, Indivior PLC) is administered subcutaneously. It is intended for patients who have begun treatment with a transmucosal buprenorphine-containing product and whose dose of that drug was adjusted after initiation of treatment and who have been receiving that adjusted dose for a minimum of 7 days.

According to prescribing information, the recommended dose of Sublocade is two monthly initial doses of 300 mg followed by 100 mg monthly maintenance doses. Increasing the maintenance dose to 300 mg monthly may be considered for patients for whom the benefits outweigh the risks.

Sublocade is a Schedule III controlled substance and should only be administered by a healthcare provider in conjunction with a complete treatment program that includes counseling and psychosocial support.

The FDA's Psychopharmacologic Drugs Advisory Committee recommended approval of Sublocade earlier this month, as reported by Medscape Medical News.

"In the Opioid Blockade Study, Sublocade achieved complete blockade of drug-liking effects for a full month in most patients. Sublocade is the first and only therapy that, at steady state, delivers buprenorphine at a sustained rate of at least 2 ng/mL over a 1-month period," Indivior CEO Shaun Thaxter said in a news release.

In the clinical trials, the overall safety profile for Sublocade was consistent with the known safety profile of transmucosal buprenorphine, except for injection site reactions, which were reported in 16.5% of patients. The most common adverse reactions (≥5% patients) included constipation, nausea, vomiting, abnormal liver enzymes levels, headache, sedation, and somnolence.

The Sublocade label contains a boxed warning stating that "serious harm or death could result if administered intravenously." It is only available through a restricted risk evaluation and mitigation strategy (REMS) program. Healthcare settings and pharmacies that order and dispense Sublocade must be certified in this program and comply with the REMS requirements.

Sublocade is expected to be available in the United States in the first quarter of 2018, the company said.

"With the approval today of a monthly formulation of the drug buprenorphine for the treatment of opioid use disorder, patients have access to a new and longer-acting option for the treatment of opioid addiction," FDA Commissioner Scott Gottlieb, MD, said in a statement.

"There are three drugs approved by the FDA for the treatment of opioid addiction: buprenorphine, methadone, and naltrexone. All three of these treatments have been demonstrated to be safe and effective in combination with counseling and psychosocial support. Everyone who seeks treatment for an opioid use disorder should be offered access to all three options. This allows providers to work with patients to select the treatment best suited to a patient's individual needs," said Dr Gottlieb.

According to federal data from the Centers for Disease Control and Prevention, since 1999, the number of overdose deaths involving opioids (including prescription opioids and heroin) quadrupled. From 2000 to 2015, more than half a million people died from drug overdoses. Currently, 91 Americans die every day from an opioid overdose.

With so many people currently addicted to opioids, the FDA is devoting "equal vigor to efforts to support the availability of lifesaving treatment to those most in need today," Dr Gottlieb said.

"This includes steps to encourage the development of new forms of MAT [medication-assisted treatment] and better formulations of the existing, approved drugs. The more widespread adoption of MAT, coupled with relevant social, medical, and psychological services, has the highest probability of being the most effective of all available treatments for opioid addiction," he added.

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