Dive Brief:
- Braeburn Pharmaceuticals, Inc. received a thumbs down from the Food and Drug Administration with the company on Sunday announcing receipt of a complete response letter for CAM2038, its buprenorphine depot to treat opioid use disorder.
- While no details have been disclosed, the FDA has asked for additional information. According to the company there is no need for additional clinical studies.
- The letter will delay approval of the agent, which was previously granted fast track and priority review designations by the FDA.
Dive Insight:
Within days of its Prescription Drug User Fee Act (PDUFA) target date of January 19, 2018, Braeburn got a response from the Food and Drug Administration, but not the answer the company was hoping for.
The U.S. is in the midst of an opioid crisis, which fueled a drop in life expectancy in 2016 for the second year running. Opioid overdose is the leading cause of death in the U.S. in people aged under 50. Between 1999 and 2016, the number of drug overdose deaths increased more than three-fold to 63,600, and between 2015 and 2016 alone, the rate of synthetic opioid-related drug overdose deaths doubled.
In September 2017, FDA Commissioner Scott Gottlieb described medication-assisted therapy, where drugs are combined with counseling and behavioral therapy, as "one of the major pillars of the federal response to the opioid epidemic in this country." Its use cuts the risk of death from all causes by half. However, in 2016, of the 11.6 million adults in the U.S. who misused opioids, only 1.1 million received medication-assisted therapy.
CAM2038 is a buprenorphine weekly and monthly depot subcutaneous injection. It is the first and only injectable that can be administered by healthcare professionals from the first day of a patient’s opioid use disorder treatment, according to the company.
"Braeburn will continue to work closely with the FDA with the goal of bringing CAM2038 to market as quickly as possible," said Mike Derkacz, president and CEO of Braeburn. "We are committed to introducing this innovative treatment to better meet the overwhelming needs of patients."
Jefferies equity analyst James Vane-Tempest suggests the CRL could set Braeburn back by four to eight months. That could benefit Indivior Plc, which is poised to launch Sublocade (buprenorphine extended-release). Braeburn had hoped to be the first company to launch a monthly injectable buprenorphine formulation for opioid use disorder, but it looks like Indivior will have that honor with a projected launch in the first quarter 2018.
Braeburn gained approval for Probuphine, the first buprenorphine implant for the maintenance treatment of opioid dependence, in May 2016. CAM2038 is also in clinical development for use in pain.