The Food and Drug Administration (FDA) has approved Cassipa (buprenorphine and naloxone; Teva) sublingual film for the maintenance treatment of opioid dependence.
Cassipa combines buprenorphine, an opioid (partial agonist-antagonist), and naloxone, an opioid antagonist. It is intended for use with a complete plan that includes counseling and psychosocial support. It should only be used after patient induction and stabilization up to a 16mg dose of buprenorphine using another marketed product. The approval of Cassipa was supported by the FDA’s finding of safety and efficacy for Suboxone sublingual film in addition to pharmacokinetic data specific to Cassipa.
Oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema are the most common adverse events associated with buprenorphine and naloxone sublingual film.
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Cassipa will be supplied in 16mg/4mg strength sublingual films and may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.
For more information call (215) 591-3000 or visit FDA.gov.
This article originally appeared on MPR
