The Food and Drug Administration has approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the medication-assisted treatment of opioid dependence.
Medication-assisted treatment (MAT) combines approved medication, such as methadone, buprenorphine, or naltrexone, with counseling and other behavioral therapies to treat opioid use disorders. Suboxone adherence reduces opioid withdrawal symptoms, the desire to use opioid, and the pleasurable effects of opioid use. Patients who receive MAT reduce their risk of death from all causes by about 50%.
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“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 June 14 press release.
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The agency said data from the Substance Abuse and Mental Health Services Administration show that patients who receive MAT as an intervention for opioid use reduce their risk of death from all causes by 50%.
Common adverse events associated with Suboxone include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.
Find the full press release on the FDA website.