The NDA for the investigative long-acting subcutaneous buprenorphine injection was turned down in lieu of more data in January.
Braeburn Pharmaceuticals is ready to give its opioid use disorder (OUD) therapy another shot at the market.
After receiving a Complete Response Letter (CRL) for investigative long-acting subcutaneous buprenorphine injection CAM2038 in late January, Braeburn has announced its New Drug Application (NDA) resubmission for the drug’s indication to treat patients with OUD.
The first NDA submission for CAM2308 included the results of 7 clinical trials that ranged from phase 1-3, testing the therapy in weekly doses of 8, 16, 24, and 32 mg, as well as monthly doses of 64, 96, 128, and 160 mg. However, the FDA requested that more data — not research — be compiled for the therapy. Mike Derkacz, president and chief executive officer of Braeburn, said in response to the CRL the company intended to work closely with the FDA to resolve the issues.
Its newest NDA is supported again by 7 clinical trials, of which Braeburn specifies 5 as involving patients with OUD — 2 of which were phase 3 trials. In the pivotal phase 3 study, CAM2038 reported non-inferiority in efficacy and safety metrics when compared to current standard-of-care sublingual buprenorphine/naloxone (SL BN). The therapies were compared for the primary endpoint of responder rate, as well as the superiority for the proportions of negative urine toxicology for illicit opioids.
The study included 428 patients to compare CAM2038 (n = 213) with SL BN (n = 215) in 2. A weekly treatment arm compared 8—24 mg per day SL BPN and placebo in the SL BN arm, and 16–32 mg per week CAM2038 with an SL placebo. A monthly treatment arm did the same with 8–32 mg per day SL BPN and 64–160 mg per month CAM2038.
Response rates for the CAM2038 arm were 17.8%, versus 14.4% in those given SL BPN (95% CI; —3.5% - 10.4%; P < 0.001). Data revealed that the CAM2038 arm performed 20% better in the cumulative distribution function (CDF) of the percent of participants with negative urine assessments (95% CI; 6.7% - 33.3%; P = 0.004).
An action date for the new NDA submission is anticipated within 30 days. If approved, CAM2038 would be the first injectable for OUD that can be administered by a health care provider from the first day of a patient’s OUD treatment. Braeburn anticipates it will offer the therapy in a range of dosage strengths for both once-weekly and once-monthly injections.
In its delay to potential market approval, the therapy and its capabilities has become an even more emphasized need in the scope of the opioid epidemic.
"The unmet need for patients and healthcare providers dealing with opioid use disorder is escalating, and Braeburn is fully committed to providing a therapy to support patients throughout their recovery journey,” Derkacz said.