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 agency said in a news release.
Both buprenorphine and naloxone have been approved previously for this purpose.
"Opioid replacement therapy can be an important part of effective treatment," said FDA Commissioner Dr. Scott Gottlieb. "Opioid use disorder should be viewed similarly to any other chronic condition that is treated with medication."
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 numbness, burning mouth, inflammation of the mouth's mucous membrane, headache, nausea, vomiting, excessive sweating and constipation.
Cassipa is produced by Teva Pharmaceuticals USA, based in New Jersey. Its parent company is located in Israel.
Visit the U.S. Food and Drug Administration.