Braeburn's Brixadi gets tentative approval
Camurus’ U.S. partner, Braeburn has received tentative approval from the Food and Drug Administration for Brixadi (buprenorphine) extended-release injection for subcutaneous use, in 8 mg, 16 mg, 24 mg, 32 mg (weekly) and 64 mg, 96 mg, 128 mg (monthly) dosage strengths.
The product is for the treatment of moderate-to-severe opioid use disorder, or OUD in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.
"Braeburn remains committed to take appropriate actions with a goal of providing US patients with OUD rapid access to a much needed, innovative long-acting treatment with flexible individualized dosing and potential to reduce the detrimental impacts of the ongoing opioid crisis," Camurus president and CEO, Fredrik Tiberg said. "The US tentative approval follows closely after the regulatory approvals of our weekly and monthly buprenorphine depots, Buvidal, in Europe and Australia and provides additional validation of our innovative FluidCrystal technology."
The product is for the treatment of moderate-to-severe opioid use disorder, or OUD in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine.
"Braeburn remains committed to take appropriate actions with a goal of providing US patients with OUD rapid access to a much needed, innovative long-acting treatment with flexible individualized dosing and potential to reduce the detrimental impacts of the ongoing opioid crisis," Camurus president and CEO, Fredrik Tiberg said. "The US tentative approval follows closely after the regulatory approvals of our weekly and monthly buprenorphine depots, Buvidal, in Europe and Australia and provides additional validation of our innovative FluidCrystal technology."