Cassipa Approved to Treat Opioid Dependence
September 7, 2018 – The U.S. FDA has approved Cassipa™ (buprenorphine and naloxone) sublingual film, manufactured by Teva Pharmaceuticals, to provide maintenance treatment of opioid dependence. Cassipa is the first buprenorphine and naloxone sublingual film to be available in a 16mg/4mg dosage strength.
Buprenorphine and naloxone sublingual films like Cassipa are used as components of medication-assisted therapy (MAT) for opioid use disorder (OUD). In MAT, which reduces patients’ risk of mortality by half, treatment combines behavioral therapy and counseling with FDA-approved medications. Cassipa should only be used once a patient has been inducted and stabilized on another FDA-approved buprenorphine product at a dose of up to 16mg.
In its press release announcing the approval of Cassipa, the FDA reiterated its commitment to improving access to OUD treatment, and reducing the stigma surrounding the disease. FDA Commissioner Scott Gottlieb emphasized that opioid replacement therapy is an important part of successful treatment, and that OUD “should be viewed similarly to any other chronic condition that is treated with medication.”
Only doctors certified under the Drug Addiction Treatment Act (DATA) will be able to prescribe Cassipa. Teva has not yet announced launch or pricing plans.