FDA Approves First Generic Version of Suboxone for Opioid Dependence

The FDA has approved the first generic version of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence. The approval comes with potential to increase access to these treatments for those with opioid use disorder.

As the nation grapples combatting the opioid epidemic, the FDA has voiced its commitment to improving access to prevention, treatment, and recovery options for those with opioid use disorder, including through approval of generics.

“The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are available to the patients who need them,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “That includes promoting the development of better drugs, and also facilitating the market for entry of generic versions of approved drugs to help ensure broader access.”

The film is applied under the tongue and serves as a medication-assisted treatment (MAT)—a comprehensive approach combining FDA-approved medications (methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. Regular adherence to MAT with buprenorphine has been shown to reduce opioid withdrawal symptoms, as well as the desire to use opioids. According to the Substance Abuse and Mental Health Services Administration, those receiving MAT treatment for opioid use disorder cut their risk of mortality from all causes in half.

Gottlieb also highlighted the importance of addressing the stigma surrounding opioid replacement therapy for those treating their addiction. “They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids. When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence,” he said.

The approval comes as part of the FDA’s continued efforts to promote drug competition in order to lower drug prices and expand access to generic treatments for patients. In June 2017, the FDA announced that it was seeking to spur innovation by allowing for accelerated approvals of generic drugs without competitors as part of its Drug Competition Action Plan.

Just yesterday, the Senate Judiciary Committee voted 16 to 5 to advance the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act). Under the act, a generic developer can bring civil action against an innovator drug company if it refuses to make available enough samples of a product for testing.