Generic Sublingual Opioid Dependence Treatment Gets FDA Approval

The US Food and Drug Administration (FDA) has approved the first generic version of Suboxone (buprenorphine and naloxone) sublingual film for use in the treatment of opioid dependence.

The film is applied under the tongue as part of medication-assisted treatment (MAT) for patients with opioid use disorder. MAT combines approved medications such as methadone, buprenorphine, or naltrexone with counseling and other behavioral therapies to treat opioid dependence.

“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,” said FDA Commissioner Scott Gottlieb, MD in a statement.

The use of buprenorphine in MAT reduces opioid withdrawal symptoms as well as the desire to use opioids by decreasing the attractive effects of other opioids. Patients receiving medication-assisted treatment for opioid abuse disorder halve their risk of death from all causes, according to the Substance Abuse and Mental Health Services Administration.

The FDA recently cleared a neurostimulation device, Drug Relief, as a non-narcotic option for relief from opioid withdrawal symptoms. The wearable device sends electrical pulses through fine needles in the ear to reduce symptoms including anxiety, agitation, depression, nausea, and opiate cravings, and increase comfort and mobility for the patient.

“The FDA is also taking new steps to address the unfortunate stigma that’s sometimes associated with the use of opioid replacement therapy as a means to successfully treat addiction,” said Gottlieb. “Patients addicted to opioids who are eventually treated for that addiction, and successfully transition onto medicines like buprenorphine, aren’t swapping one addiction for another, as is sometimes unfortunately said. They’re able to regain control of their lives and end all of the destructive outcomes that come with being addicted to opioids.”

The FDA seeks to encourage the broader use of MAT by approving generic versions of the treatment options. Through its Drug Competition Action Plan, the agency seeks to improve the efficiency of the generic drug approval process and address the challenges to generic drug development.

“When coupled with other social, medical, and psychological services, medication-assisted treatments are often the most effective approach for opioid dependence,” said Gottlieb.