Braeburn Pharmaceuticals Inc. and Camurus AB on Thursday, July 20 submitted their new drug application to the U.S. Food and Drug Administration for a long-acting opioid addiction treatment.
The medication known as CAM2038 uses weekly or monthly injections to alleviate lasting cravings and withdrawal for people with opioid use disorder, a disease affecting 2.6 million Americans, according to the National Institute on Drug Abuse.
CAM2038 is on the FDA's Fast Track, meaning the FDA is working to expedite the development and review process of the drug, but Braeburn -- Apple Tree Partners' private commercial-stage pharmaceutical company based in Princeton, New Jersey -- has applied for priority review of the medication, which leads to an even quicker review than Fast Track.
The FDA's goal for priority review applicants is take action on their drug within six months instead of the 10 months a typical Fast Track review can take. If the FDA approves the medication for priority review and then for medical use, CAM2038 could be available by the end of 2018's first quarter, Mike Derkacz, Braeburn's new president and CEO, told TheStreet on Thursday.
"This is what we say is our flagship product," Derkacz said. "We're exclusively focusing on being a leader in addiction medicine. Our mission is to advance what are next generation therapies that are individualized for patient needs and make a lasting impact on this awful opioid crisis."
CAM2038 uses buprenorphine, an opioid agonist that attaches to opioid receptors in the brain to reduce cravings and symptoms of withdrawal. Physicians would administer the medication under the skin, and the lipid-based technology developed by Camurus, a Swedish research pharmaceutical and biotechnology company, would slowly dissipate the medicine over a week or month depending on the formulation.