FDA Approves New Dosage of Buprenorphine and Naloxone Film for Opioid Dependence

FDA Approves New Dosage of Buprenorphine and Naloxone Film for Opioid Dependence

The FDA has approved Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. While similar sublingual films – which dissolve under the tongue – already exist for the treatment of opioid dependence, Cassipa introduces a new dosage strength of 16 mg/4mg.

Cassipa should be used as part of a medication-assisted therapy (MAT) program that combines medications with counseling and other behavioral therapies to treat opioid use disorder. Furthermore, Cassipa may only be prescribed after the patient has been stabilized with a different buprenorphine product with a dose no greater than 16mg.

Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids, without causing the cycle of highs and lows associated with opioid misuse or abuse. At proper doses, buprenorphine also decreases the pleasurable effects of other opioids, making continued opioid abuse less attractive.

Adverse effects commonly associated with Cassipa include 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).

For further information, read the FDA News Release.