Today, the FDA announced the approval of Cassipa, developed by Teva Pharmaceuticals for the maintenance treatment of opioid dependence.
“There’s an urgent need to ensure access to, and wider use and understanding of, medication-assisted treatment for opioid use disorder,” Scott Gottlieb, MD, FDA Commissioner, said in the announcement. “The introduction of new treatment options has the potential to broaden access for patients.”
A sublingual film designed to be applied under the tongue, Cassipa (buprenorphine and naloxone, Teva Pharmaceuticals) contains 16 mg of buprenorphine and 4 mg of naloxone. The FDA approval includes both the brand name and generic versions in various dosage strengths.
The combination of buprenorphine and naloxone was approved through 505(b)(2) pathway, an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act.
According to the release, the medication should be used alongside counseling and psychosocial support as part of a complete treatment plan. Additionally, another marketed product should be used to induct and stabilize patients up to a 16-mg dose before starting buprenorphine and naloxone.
Adverse events may include oral numbness, burning mouth, inflammation of the oral mucous membrane, headache, nausea, vomiting, excessive sweating, constipation, signs and symptoms of withdrawal, insomnia, pain and peripheral edema.
Only Drug Addiction Treatment Act-certified providers can prescribe this medication.
“Opioid replacement therapy can be an important part of effective treatment,” Gottlieb said. “Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication.”
Disclosures: Gottlieb is the FDA Commissioner.