FDA Approves Long-Acting Version of Drug for Opioid Use Disorder

The FDA approved an injectable form of the drug buprenorphine for the treatment of moderate-to-severe opioid use disorder.

Marketed under the name Sublocade, the FDA said the drug should be used as part of a complete treatment program that includes counseling and psychosocial support. Sublocade comes in a pre-filled syringe.

Buprenorphine is 1 of 3 drugs currently approved for medication-assisted treatment (MAT) for opioid addiction (the other 2 are methadone and naltrexone).

According to Stat News, Indivior is the first company to gain approval for a monthly injection of buprenorphine. The company currently makes Suboxone, a daily medicine that combines buprenorphine with naloxone.

"Given the scale of the opioid crisis, with millions of Americans already affected, the FDA is committed to expanding access to treatments that can help people pursue lives of sobriety. Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each individual patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan,” said FDA Commissioner Scott Gottlieb, MD. “As part of our ongoing work in supporting the treatment of those suffering from addiction to opioids, the FDA plans to issue guidance to expedite the development of new addiction treatment options.”

The new drug costs $1580 per monthly dose. The older version costs $100 a month, according to Modern Healthcare.

The most common side effects from treatment with Sublocade include constipation, nausea, vomiting, headache, drowsiness, injection site pain, itching (pruritus) at the injection site, and abnormal liver function tests. The safety and efficacy of Sublocade have not been established in children or adolescents less than 17 years of age. Clinical studies of the product did not include participants over the age of 65.