Teva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) as the maintenance treatment for opioid dependence.
The FDA has approved new dosage strength (16mg / 4mg) of Cassipa (buprenorphine and naloxone) sublingual film. It is also approved in both brand name and generic versions, as well as various strengths.
Medication-assisted treatment (MAT) is a comprehensive approach, which aggregates FDA-approved medications, including methadone, buprenorphine, or naltrexone, with counseling and other behavioral therapies to treat patients with opioid use disorder (OUD).
According to the FDA, Cassipa must be used under complete treatment plan, which includes counseling and psychosocial support.
The treatment must be used after patient induction and stabilization up to a dose of 16mg of buprenorphine using another marketed product.
Some of the adverse events associated with 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) and constipation.
In August this year, the FDA has published issued draft guidance for drug-developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products.
Regular adherence to MAT with buprenorphine will help reduce pioid withdrawal symptoms and the interest to use opioids.