MONDAY, Sept. 10, 2018 (HealthDay News) -- Cassipa (buprenorphine and naloxone), a film designed to be placed under the tongue, has been approved to treat opioid dependence, the U.S. Food and Drug Administration said in a news release.
Both buprenorphine and naloxone have been approved previously for this purpose. Cassipa was approved through an abbreviated approval pathway, called the 505(b)(2) pathway.
The newly approved drug duo should be part of a complete treatment plan that includes counseling and psychosocial support to treat people with opioid use disorder. Cassipa may only be dispensed by approved prescribers, the agency said. Side effects of the drugs include oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, and constipation.
"Opioid replacement therapy can be an important part of effective treatment," FDA Commissioner Scott Gottlieb, M.D., said in a statement. "Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication."
Cassipa is produced by Teva Pharmaceuticals USA, based in New Jersey. Its parent company is located in Israel.