FDA Clears First Generic Versions of Suboxone Sublingual Film


The US Food and Drug Administration (FDA) has approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film for the treatment of opioid dependence, which may increase access to treatment, the agency said.

Mylan Technologies Inc and Dr. Reddy’s Laboratories SA received approval to market buprenorphine and naloxone sublingual film in multiple strengths.

“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 a news release.

Buprenorphine and naloxone sublingual film should be used as part of medication-assisted treatment (MAT), which combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies, for patients with opioid use disorder (OUD), the FDA advises.

Adverse events commonly observed with buprenorphine and naloxone sublingual film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema. These products may only be prescribed by Drug Addiction Treatment Act (DATA)–certified prescribers.

“Improving access to prevention, treatment and recovery services, including the full range of MAT, is a focus of the FDA’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,” the agency said.

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The FDA is also focusing its efforts on decreasing exposure to opioids and preventing new addiction by encouraging more appropriate prescribing; supporting the treatment of those with OUD and promoting the development of improved as well as lower cost forms of MAT; fostering the development of novel pain therapies that may not be as addictive as opioids, and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products.

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