colleen, Author at Braeburn

23 Jul U.S. District Court Orders FDA to Reconsider Application for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

Posted at 08:52h in Press Release

Plymouth Meeting, Pa. – July 23, 2019 – The U.S. District Court for the District of Columbia (District Court) granted...

04 Jun Braeburn Announces Publication of Phase 3 Study Results Showing Long-term Safety and Effectiveness of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder

Posted at 06:50h in Press Release

Individualized treatment with BRIXADI weekly and monthly was well-tolerated and effective, with a high (73.6%) treatment retention of patients throughout...

22 Apr Philadelphia Business Journal, April 9, 2019

Posted at 11:14h in In the News

Battle brewing over opioid abuse disorder drugs By John GeorgeBraeburn Inc. filed a Citizen Petition with the Food and Drug Administration...

09 Apr Citizen Petition Calls on FDA to Revoke Orphan Designation for Sublocade

Posted at 08:11h in Press Release

Allowing Orphan Designation Violates the Intent of the Orphan Drug Act, and if Orphan Exclusivity is Granted, No New Buprenorphine...

06 Apr Positive Treatment Results for BRIXADI™ (buprenorphine) Extended-Release Injection in Fentanyl Positive Patients Presented at the 50th Conference of the American Society of Addiction Medicine

Posted at 11:50h in Press Release

Phase 3 post-hoc analyses indicate less fentanyl and overall illicit opioid use for weekly/monthly buprenorphine depots versus daily standard treatment Plymouth...

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...

26 Oct Guest CEO Blog: SUPPORT for Patients and Communities – Important advances in the fight against OUD

Posted at 12:47h in Culture

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text]Yesterday, the President of the United States signed the SUPPORT for Patients and Communities Act into...

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...

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...

17 Sep Celebrating Recovery Month

Posted at 16:02h in Culture

[vc_row css_animation="" row_type="row" use_row_as_full_screen_section="no" type="full_width" angled_section="no" text_align="left" background_image_as_pattern="without_pattern"][vc_column][vc_column_text]This past weekend, many on Team Braeburn participated in the Rock ‘n’ Roll...

Author: colleen