FDA approves first generic versions of Suboxone for opioid dependence

Scott Gottlieb

The FDA has approved the first generic versions of Suboxone sublingual film for the treatment of opioid dependence, according to a press release.

Suboxone (Indivior) is a combination of buprenorphine and naloxone.

This approval is part of the FDA’s focus to advance the development of new treatments for opioid dependence, as well as encourage their widespread use through the approval of generic versions of medication-assisted treatment (MAT), according to the release. The agency plans to improve the efficiency and to tackle developmental barriers of the generic drug approval process to lower drug prices and promote access to safe, effective generic medicines in the U.S.

“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” FDA Commissioner Scott Gottlieb, MD, said in the release. “When coupled with other social, medical and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence.”

Common adverse effects of Suboxone sublingual film include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema. Buprenorphine and naloxone sublingual film products may only be prescribed when the clinician has Drug Addiction Treatment Act certification and should be used as part of a complete treatment plan that also includes counseling and psychosocial support, according to the release.