Braeburn in the News

Don’t let the maker of a buprenorphine drug abuse the Orphan Drug Act
STAT, May 28, 2019
By Diane Dorman

In Midst Of Opioid Crisis, FDA May Block New Addiction Drug From Market
NPR, May 24, 2019
By Alison Kodjak

Drug maker accuses FDA of hampering its medication for opioid treatment
Washington Post, April 9, 2019
By Paige Winfield Cunningham

Battle brewing over opioid abuse disorder drugs
Philadelphia Business Journal, April 9, 2019
By John George

Braeburn is committed to working with stakeholders and advocacy groups to improve outcomes for patients and their families. Check out our CEO’s testimony at the 43 minute mark.

Media Relations

Colleen Saltmer

Press Releases

 FDA revokes Indivior PLC’s orphan designation for opioid use disorder (OUD)* and prevents an additional five-year block of other monthly buprenorphine depot products for OUDPlymouth Meeting, Pa. – November 7, 2019 – Braeburn Inc. is pleased to confirm that it will seek, and is eligible for, marketing approval for...

Plymouth Meeting, Pa. – July 23, 2019 – The U.S. District Court for the District of Columbia (District Court) granted Braeburn’s motion for summary judgment, vacating the U.S. Food and Drug Administration’s (FDA) December 2018 exclusivity determination which blocked BRIXADI from final approval through November 30, 2020. Braeburn’s application for...

Individualized treatment with BRIXADI weekly and monthly was well-tolerated and effective, with a high (73.6%) treatment retention of patients throughout the 48-week study period.More than 80% of the patients converted from daily sublingual buprenorphine responded that BRIXADI was “much better” or “slightly better” than their previous treatment.Plymouth Meeting, Pa. –...

Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment Plymouth Meeting, Pa. — April 6, 2019 — Braeburn Inc. announces positive post-hoc analyses results from the randomized, double-blind, double-dummy Phase 3 study of BRIXADI™ (buprenorphine) extended-release weekly and monthly injections...

 BRIXADI™ is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way healthcare providers treat patients with OUDPlymouth 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...

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...

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...

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...

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