FDA approves Cassipa for opioid dependence


A new dosage strength of buprenorphine and naloxone sublingual film was approved on Sept. 7 by the Food and Drug Administration.

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Cassipa sublingual film, made by Teva Pharmaceuticals, is a 16 mg/4 mg dosage of buprenorphine and naloxone for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual film also is approved in both brand name and generic versions and in various strengths, the FDA said in a press release.

Cassipa should be used as part of a complete treatment plan that includes counseling and psychosocial support and should be used only after patient induction and stabilization up to a dose of 16 mg of buprenorphine using another marketed product. These products may only be prescribed by Drug Addiction Treatment Act (DATA)–certified prescribers.

“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder ... 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,” FDA Commissioner Scott Gottlieb, MD, said in the statement.

He added that “individuals who successfully transition onto medication-assisted treatment are not swapping one addiction for another. Opioid replacement therapy can be an important part of effective treatment. Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication.”

Medication-assisted treatment (MAT) is a comprehensive approach that combines FDA-approved medications (currently methadone, buprenorphine, or naltrexone) with counseling and other behavioral therapies to treat patients with opioid use disorder. Regular adherence to MAT with buprenorphine reduces opioid withdrawal symptoms and the desire to use opioids. According to the Substance Abuse and Mental Health Services Administration, patients receiving MAT for treatment of their opioid use disorder cut their risk of death from all causes in half.

Improving access to prevention, treatment, and recovery services, including the full range of MAT, is part of the Department of Health and Human Services’ Five-Point Strategy to Combat the Opioid Crisis. Last month, the FDA issued draft guidance outlining new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products, building on another draft guidance issued in April outlining the agency’s current thinking about drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation). In June, the agency also approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film in multiple strengths, the statement said.

Cassipa was approved through the abbreviated 505(b)(2) approval pathway and its application relied, in part, on the FDA’s finding of safety and effectiveness for Suboxone sublingual film to support approval. The applicant demonstrated that reliance on the FDA’s finding of safety and effectiveness for Suboxone was scientifically justified and provided Cassipa-specific pharmacokinetic data to establish the drug’s safety and efficacy for its approved uses, according to the FDA.

Adverse events commonly observed with the buprenorphine and naloxone sublingual film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, signs and symptoms of withdrawal, insomnia, pain, and peripheral edema.


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