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 monthly buprenorphine depot injection designed to treat adults with opioid use disorder.
“We are extremely pleased that this group of leading healthcare investors recognizes the potential of CAM2038, once approved, for which the FDA has granted priority review,” president & CEO, Mike Derkacz, said in prepared remarks.
“With opioid overdose now the leading cause of death among Americans under the age of 50, at Braeburn we are committed to playing our part by advancing new weekly and monthly medication-assisted treatments (MAT) to help support the recovery of people and their families devastated by opioid use disorder.”
Just 1.1 million of the 11.6 million people who misused opioids in the U.S. in 2016 received medication-assisted treatment, according to the Substance Abuse and Mental Health Services Administration.
“Consistent with FDA Commissioner Gottlieb’s recent statement encouraging wider, appropriate use of MAT for opioid addiction treatment, this financing further supports our efforts to expand treatment options by advancing CAM2038,” Derkacz added.
In September, the FDA granted priority review to Braeburn’s NDA for CAM2038. The agency is slated to decide whether it will approve or reject the product’s application by Jan. 19.
The subcutaneous injection is set to be offered in dosage strengths for once-weekly and once-monthly administration in pre-filled syringes.
CAM2038’s NDA included positive results from a pivotal Phase III trial, demonstrating non-inferiority versus treatment with the current standard of care – a daily sublingual buprenorphine/naloxone product.
Braeburn’s depot also had a safety profile that was consistent with the known safety profile of buprenorphine, except for some mild-to-moderate adverse events at the injection site.