FDA Approves New Opioid Dependence Drug Dosage

The FDA has approved a new dosage of buprenorphine and naloxone sublingual film in the form of Cassipa (16 milligrams/4 milligrams). The combination is also available various other strengths and versions.

The approval came through an abbreviated pathway in which a new drug may rely on the FDA’s finding that a previous drug was safe or effective so long as such a connection is justified. The approval of Cassipa relied, in part, on the safety and effectiveness data for Suboxone sublingual film.

Cassipa is intended for use with psychosocial support and counseling and should only be used after patient induction and stabilization up to a dose of 16 milligrams of buprenorphine using another marketed product.

The most common adverse events associated with buprenorphine and naloxone sublingual film are oral hypoesthesia, glossodynia, oral mucosal erythema, headache, nausea, vomiting, hyperhidrosis, constipation, insomnia, and pain and peripheral edema.

—Michael Potts

Reference:

FDA. FDA approves new dosage strength of buprenorphine and naloxone sublingual film as maintenance treatment for opioid dependence [press release]. September 7, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm619864.htm.