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FDA Approves New Dosage of Buprenorphine/Naloxone Sublingual Film

September 11, 2018
The approval of Teva’s Cassipa boosts agency’s medication-assisted treatment efforts

A PPM Brief

FDA has approved1 Cassipa (buprenorphine and naloxone) sublingual film from Teva Pharmaceuticals (North Wales, PA), offering a new dosage strength for the maintenance of opioid dependence of up to 16 mg/4 mg.

FDA notes that Cassipa can only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers, and should be used as part of a complete treatment plan that includes counseling and psychosocial support; in addition, the medication should only be used after patient induction and stabilization up to a dose of 16 mg of buprenorphine using another marketed product.1 Adverse events commonly observed include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.

“The FDA recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This streamlined approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment,” said FDA Commissioner Scott Gottlieb, MD. “We’ve taken a number of steps to advance the development of new FDA-approved treatments for opioid dependence and encourage health care professionals to ensure patients are offered an adequate chance to benefit from these therapies.”

Teva Pharmaceuticals had submitted an abbreviated approval pathway for Cassipa that relied partly on FDA’s finding of safety and effectiveness for suboxone sublingual film to support its approval, providing Cassipa-specific pharmacokinetic data to establish the drug’s safety and efficacy for its approved uses.1

Last updated on: October 11, 2018
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FDA Approves First Generic Versions of Suboxone Sublingual Film
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