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news.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.
Image: The US FDA’s Center for Drug Evaluation and Research. Photo: courtesy of The U.S. Food and Drug Administration.
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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In August this year, the FDA has published issued draft guidance for drug-developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products.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.
Patients securing MAT for treatment of their OUD cut their risk of death from all causes in half, as per the Substance Abuse and Mental Health Services Administration.
In June this year, the FDA also approved first generic versions of Suboxone (buprenorphine and naloxone) sublingual film in multiple strengths.
FDA commissioner Dr Scott Gottlieb said: “There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder. The introduction of new treatment options has the potential to broaden access for patients.
“For example, the FDA recently described a streamlined approach to drug development for certain medication-assisted treatments that are based on buprenorphine. This streamlined approach can reduce drug development costs, so products may be offered at a lower price to patients and we can broaden access to treatment.”
