We are pleased to announce that we have submitted our Request for Final Approval to FDA as the next step in our mission to fight the opioid crisis.
We are pleased to announce that FDA has granted our Citizen Petition and revoked orphan designation, enabling access to new treatments for patients with OUD.
At Braeburn, everything we think, say and do is with patients in mind. Filing this Petition was necessary to bring vital treatment options to patients suffering with opioid addiction as soon as possible.
CAM2038 received a positive opinion from CHMP – great news for patients in Europe with opioid dependence.
We are pleased to announce the positive top-line results for a Phase 3 efficacy and safety study.
We’re pleased FDA has assigned a December 26 PDUFA date for our Fast Track and Priority Review NDA for CAM2038 for the treatment of moderate-to-severe #OpioidUseDisorder and are eager to work closely as we move forward.
Opioid overdoses are an increasing public health burden in the United States. Today, Braeburn hosts a congressional briefing to explore how “warm hand-off” protocols can help reduce post-emergency department visits and increase treatment adherence.