Media

Braeburn in the News

FDA admits it goofed when granting orphan status to an opioid addiction treatment
STAT, November 8, 2019
Ed Silverman

US FDA Revokes Orphan Drug Designation
Pink Sheet, November 11, 2019
Sue Sutter

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Press Releases

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23 Dec Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder

Posted at 14:00h in Press Release

BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUD Plymouth Meeting, Pa. — December 23, 2018 — Braeburn today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval of BRIXADI (buprenorphine) extended-release weekly...

21 Sep CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe

Posted at 11:23h in Press Release

Plymouth Meeting, PA—September 21, 2018 — Braeburn announces that Camurus has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of CAM2038, an investigational buprenorphine flexible-dose weekly and monthly subcutaneous depot injection for the treatment of adults age...

18 Sep Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy

Posted at 10:00h in Press Release

Plymouth Meeting, PA—September 18, 2018 — Braeburn announces positive top-line results for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. CAM2038 is an investigational buprenorphine weekly and monthly subcutaneous depot injection for healthcare professional...

16 Jul Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder

Posted at 08:00h in Press Release

If approved, CAM2038 will provide patients and HCPs with flexible-dose weekly and monthly options for the treatment of opioid use disorder, with the goal of improving treatment adherence and reducing the burdens associated with daily medication. Plymouth Meeting, Pa. —July 16, 2018 —Braeburn announces that the U.S. Food and Drug Administration...

25 Jun Braeburn Appoints Richard Malamut, M.D. as Chief Medical Officer

Posted at 14:54h in Press Release

Plymouth Meeting, PA—June 25, 2018—Braeburn announces that Richard Malamut, M.D. has joined the company as Chief Medical Officer. Dr. Malamut brings to Braeburn more than 25 years of pharmaceutical and clinical leadership experience at emerging and leading biopharmaceutical companies. Dr. Malamut will lead a team of clinical and medical professionals that...

30 May Titan Pharmaceuticals and Braeburn Announce Mutual Termination of License Agreement for Probuphine® for Opioid Dependence

Posted at 16:23h in Press Release

SOUTH SAN FRANCISCO, CA and PLYMOUTH MEETING, PA – May 30, 2018 – Titan Pharmaceuticals, Inc. (NASDAQ:TTNP) and Braeburn announce that they have agreed to terminate the December 2012 license agreement, which granted Braeburn exclusive rights to commercialize Probuphine in the United States and Canada. Under the terms of the termination...

28 May Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder

Posted at 16:21h in Press Release

Plymouth Meeting, Pa. —May 28, 2018 — Braeburn announces the resubmission of the New Drug Application (NDA) for CAM2038, an investigational buprenorphine flexible-dose weekly and monthly depot injection for the treatment of opioid use disorder (OUD). The resubmission is in response to the Complete Response Letter issued by the U.S....

14 May Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine

Posted at 16:17h in Press Release

Head-to-head study of CAM2038 versus daily sublingual buprenorphine CAM2038 met FDA primary endpoint of non-inferiority (p<0.001) to sublingual buprenorphine CAM2038 demonstrated statistical superiority for the key secondary endpoint (p=0.004) Plymouth Meeting, Pa.—May 14, 2018— Braeburn announced today that the results from its Phase 3 study to evaluate the efficacy and...

12 Apr Braeburn Launches Brave Action

Posted at 16:12h in Press Release

New Resource For Dedicated Healthcare Professionals Treating Opioid Use Disorder Princeton, N.J.—April 12, 2018 — Braeburn, as part of its overall efforts to improve the lives of patients with Opioid Use Disorder (OUD), announced today the launch of Brave Action, a new disease-focused resource to support the many healthcare providers on...

21 Jan Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot

Posted at 16:06h in Press Release

Princeton, N.J.—January 21, 2018 — Braeburn Pharmaceuticals, Inc. (Braeburn) today announced that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the new drug application (NDA) for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with...

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