The U.S. Food and Drug Administration (FDA) said Thursday that it has approved Indivior’s Sublocade, the first monthly injectable buprenorphine product for the treating opioid use disorder (OUD), also known as opioid addiction. The treatment is approved for patients who have initiated treatment with transmucosal buprenorphine-containing products.

Buprenorphine is the primary form of treatment for opioid addiction in the U.S. However, until recently it was only approved to administer as a tablet or film that dissolves in the mouth, or as an implant.

Sublocade is expected to provide a new treatment option for patients in recovery, such as reducing the burden of taking medication daily as prescribed. The agency also advised patients to use Sublocade as part of a complete treatment program that includes counseling and psychosocial support, also known as medication-assisted treatments (MAT).

A total of 848 adults with a diagnosis of moderate-to-severe OUD, who began treatment with buprenorphine or naloxone sublingual film, a film absorbed under the tongue, participated in the two clinical studies, randomized and open-label, to evaluate the safety and efficacy of Sublocade.

Results indicated that Sublocade-treated patients had more weeks without opioid-positive urine tests or self-report of opioid use, and a higher proportion of patients had no evidence of illicit opioid use throughout the treatment period, compared to the placebo group.

"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,” FDA Commissioner Scott Gottlieb said. “Everyone who seeks treatment for opioid use disorder deserves the opportunity to be offered the treatment best suited to the needs of each patient, in combination with counseling and psychosocial support, as part of a comprehensive recovery plan.”

Gottlieb went on to say, “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.”

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