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FDA Approves First Generic Versions of Suboxone Sublingual Film

Agency continues efforts toward medication-assisted treatment

A PPM Brief

FDA announced1 that it has approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence. Mylan Technologies (St. Albans, VT) and Dr. Reddy's Laboratories SA (Hyderabad, India) have received approval to market buprenorphine and naloxone sublingual film in multiple strengths.

The agency said that it is encouraging access and wider use of medication-assisted treatment (MAT) through the approval of generic versions of these products to “promote competition to help reduce drug prices and improve access to safe and effective generic medicines for Americans.” This focus on the full range of MAT is part of the agency’s ongoing work to reduce the scope of the opioid crisis and one part of the US Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. According to the Substance Abuse and Mental Health Services Administration (SAMHSA), individuals receiving MAT often demonstrate dramatic improvement in addiction-related behaviors and psychosocial functioning. In addition, FDA recently approved a new wearable neurotransmitter for the treatment of opioid withdrawal during detox.

“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.

The agency recommends that buprenorphine and naloxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support; these products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers. Adverse events commonly observed with suboxone include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.

Last updated on: June 15, 2018
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