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FDA Approves Cassipa for Opioid Addiction Treatment

FDA news release; 2018 Sep 7

The US Food and Drug Administration FDA) recently approved Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) 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 is manufactured by Teva Pharmaceuticals USA Inc., headquartered in North Wales, PA.

Dosage/administration: 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. These products may only be prescribed by Drug Addiction Treatment Act (DATA)-certified prescribers.

Adverse effects: Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia (numbness), glossodynia (burning mouth), oral mucosal erythema (inflammation of oral mucous membrane), headache, nausea, vomiting, hyperhidrosis (excessive sweating), constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema (accumulation of fluid causing swelling in lower limbs).


FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence. [news release]. North Wales, PA: Teva Pharmaceuticals USA Inc. September 7, 2018. Accessed September 10, 2018.