New Dosage of Buprenorphine and Naloxone Sublingual Film

Approved as Maintenance Treatment for Opioid Dependence

The FDA approved Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16 milligrams/4 milligrams) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths.

Cassipa was approved through the (abbreviated) 505(b)(2) pathway on the basis of an application that relied, in part, on the FDA’s finding of safety and effectiveness for Suboxone sublingual film to support approval. The application demonstrated that reliance on the FDA’s finding of safety and effectiveness for Suboxone was scientifically justified and provided Cassipa-specific pharmacokinetic data to establish the drug’s safety and efficacy for its approved uses.

Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support and should only be used after patient induction and stabilization up to a dose of 16 milligrams of buprenorphine using another marketed product. Adverse events commonly observed with the 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.

Source: FDA.gov, September 7, 2018