Clarification on Braeburn's CAM2038/Brixadi/Buvidal

Abstract

In our recent article “Sublocade: Why a placebo arm?” (see ADAW, March 11), we referred to the investigational medication CAM2038, an injectable (weekly subcutaneous depot) form of buprenorphine that is competing with Sublocade in the buprenorphine market. To make the terminology clear, the name of the investigational medication, developed by Braeburn in partnership with Camurus (Braeburn's European partner), is Brixadi. In Europe and Australia, however, the product is approved and marketed by Camurus under the trade name Buvidal. The Food and Drug Administration (FDA) granted tentative approval to Brixadi in December 2018, but Sublocade has exclusivity. “Brixadi's clinical development program was designed with input from the FDA,” said Sonnie Kim, Pharm.D., Braeburn vice president and head of medical affairs, in an email to ADAW. CAM2038 was found effective in Phase 2 research (see ADAW, June 26, 2017). The most recent results were published in JAMA Internal Medicine (https://jamanetwork.com/journals/jamainternalmedicine/article‐abstract/2681061). We regret any confusion. For more information, go to www.braeburnrx.com.