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 information […]
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 and […]
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. Get the full story at […]
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. Get […]
Braeburn, Camurus tout long-term phase III data for opioid addiction therapy
Braeburn Pharmaceuticals and Camurus (STO:CAMX) touted data today from a long-term Phase III study of its weekly and monthly buprenorphine depots in patients with moderate-to-severe opioid use disorder. The safety and efficacy study enrolled 228 patients and 71% of participants completed the 48-week treatment. The safety profile of CAM2038 was comparable to previous, shorter studies, […]
Braeburn’s risperidone implant meets primary endpoint in schizophrenia trial
Braeburn Pharmaceuticals said yesterday that a 6-month study of its risperidone implant in patients with schizophrenia or schizoaffective disorder met its primary endpoint. Risperidone, the most commonly-prescribed therapy for schizophrenia, depends on consistent administration, but patients with schizophrenia sometimes stop taking their medication when their symptoms improve. Long-acting, injectable formulations of risperidone are on the market, […]
Opioid treatment implant-maker Braeburn secretly funded advocacy group fronted by Gingrich
Opioid treatment implant-maker Braeburn Pharmaceuticals said in a regulatory filing last month that it has made charitable donations to an advocacy group fronted by Newt Gingrich and Patrick Kennedy known as Advocates for Opioid Recovery. The group lobbies for more government funding and insurance coverage for opioid maintenance treatments. Former Republican House speaker Gingrich and former […]
Braeburn pulls the plug on $150m IPO, citing market conditions
Braeburn Pharmaceuticals pulled its plans for a $150 million initial public offering yesterday, citing unstable market conditions. The Princeton, N.J.-based company 1st announced plans to go public in late December and in mid-January, Braeburn said it planned to raise $150 million by offering 7,692,308 shares of its common stock at $18.00 to $21.00 apiece. The company […]
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