Braeburn said this week that it won tentative FDA approval for its Brixadi extended-release weekly and monthly buprenorphine injections. The company’s product is designed for the treatment of moderate to severe opioid use disorder in people who have already started treatment with buprenorphine. The FDA acknowledged that Braeburn met all required quality, safety and efficacy […]
Braeburn Pharmaceuticals
Titan, Braeburn end commercialization deal for Probuphine drug-delivery implant
Titan Pharmaceuticals (NSDQ:TTNP) and Braeburn Pharmaceuticals said today that they plan to end a 2012 licensing agreement that gave Braeburn exclusive rights to commercialize Probuphine in the U.S. and Canada. Probuphine, which was developed using Titan’s ProNeura continuous drug-delivery tech, is an implant that can be placed in a patient’s upper arm in an outpatient office […]
Braeburn dealt setback over monthly, weekly opioid abuse therapy
The FDA has issued a complete response letter to Braeburn Pharmaceuticals, denying its application for an investigational weekly and monthly buprenorphine depot injection designed to treat adults with opioid use disorder. The company reported that the dreaded CRL does not request additional clinical studies, but Braeburn did not elaborate as to what sort of additional […]
Braeburn raises $110m for opioid use disorder depot injection
Braeburn Pharmaceuticals has raised $110 million in a mezzanine round of financing led by Wellington Capital. Other investors included Avista Capital Partners, RA Capital Management, Deerfield Management and Apple Tree Partners. The Princeton, N.J.-based company said it plans to use the new funds to support the FDA approval process and commercialization of CAM2038, a weekly […]
Braeburn’s buprenorphine depot wins priority review from FDA
Braeburn Pharmaceuticals said today that the FDA granted priority review to the company’s CAM2038 NDA. The investigational weekly and monthly buprenorphine depot injection was designed to treat adults with opioid use disorder. The regulatory agency is slated to make a decision about CAM2038 by January 10, 2018. “FDA’s acceptance of our NDA for CAM2038 under […]
Braeburn, Camurus seek FDA nod for buprenorphine depot
Camurus AB (STO:CAMX) and Braeburn Pharmaceuticals said today that the companies submitted a new drug application to the FDA for its weekly and monthly buprenorphine depots to treat opioid use disorder. Braeburn also reported that it applied for priority review of its application, which could potentially shorten the company’s path to the market. The NDA submission was supported […]
Titan Pharmaceuticals partners for long-acting antimalarial implant
Titan Pharmaceuticals (NSDQ:TTNP) this month revealed a collaboration with the Walter Reed Army Institute of Research to evaluate the use of its ProNeura drug-delivery technology for the long-term prevention of malaria. The company is already working to develop its implant for an array of applications. Titan president & CEO Sunil Bhonsle told Drug Delivery Business News that this […]
Camarus, Braeburn tout Phase II data for long-acting buprenorphine depot
Camarus AB (STO:CAMX) and Braeburn Pharmaceuticals touted data yesterday from a Phase II trial of its long-acting buprenorphine depot. The 47-patient trial found that CAM2038 blocks the effects of opioids and suppresses withdrawal symptoms in adults with opioid use disorder. The in-patient trial included 5 3-day test sessions to evaluate the patients’ response to randomized […]
Braeburn names former Teva exec as new president, CEO | Personnel Moves – June 14, 2017
Braeburn Pharmaceuticals said last week that it named Michael Derkacz as president and CEO of the buprenorphine implant-maker. Most recently, Derkacz worked as senior VP and head of global central nervous system and pain therapeutic areas for Teva Pharmaceuticals (NYSE:TEVA). Behshad Sheldon, who helped to found Braeburn in 2012, is slated to step down from Braeburn […]
Braeburn, Knight seek Health Canada nod for opioid dependence implant
Braeburn Pharmaceuticals and Knight Therapeutics (TSE:GUD) said today that Health Canada has agreed to review Knight’s new drug submission for Probuphine, a buprenorphine subdermal implant designed to treat opioid drug dependence. In February last year, Braeburn and Knight inked an exclusive distribution and sublicense deal, giving Knight the exclusive right to distribute Probuphine in Canada. Braeburn’s […]
