CAM2038

also known as buprenorphine

Developed for: opiate dependence
Investigated by: Alameda Health System · Braeburn Pharmaceuticals · Harvard Medical School (HMS and HSDM) · Icahn School of Medicine at Mount Sinai · NYU Langone Health · National Drug Abuse Treatment Clinical Trials Network
+5 more
· National Institute on Drug Abuse (NIDA) · The Emmes Company, LLC · University of Pennsylvania · Weill Medical College of Cornell University · Yale University

Trials 2

today NCT04225598 · Ph 2 NCT02710526 · Ph 2

2015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 2	NCT04225598	Jul 2020 → Dec 2024	opiate dependence	Yale University	Completed	No outcome recorded
Phase 2	NCT02710526	Feb 2015 → May 2017	chronic pain syndrome, opiate dependence	Braeburn Pharmaceuticals	Completed	No outcome recorded

Press releases naming this drug 53 releases

Date	Issuer	Release
2026-05-28	Braeburn Pharmaceuticals	Braeburn Presents New Data at 2026 ASCP Annual Meeting Demonstrating Opioid Withdrawal Suppression at Low Buprenorphine Plasma Concentrations braeburnrx.com ↗
2023-09-05	Braeburn Pharmaceuticals	BRIXADI® (buprenorphine) Extended-Release Injection for Subcutaneous Use (CIII) is Now Available in the U.S. for the Treatment of Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2023-05-23	Braeburn Pharmaceuticals	Braeburn’s BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection (CIII) Receives FDA Approval for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2022-12-08	Braeburn Pharmaceuticals	FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2022-11-23	Braeburn Pharmaceuticals	Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2021-06-26	Braeburn Pharmaceuticals	FDA Accepts Braeburn’s New Drug Application Resubmission for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2021-06-15	Braeburn Pharmaceuticals	Braeburn Resubmits New Drug Application for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2020-12-02	Braeburn Pharmaceuticals	Braeburn Receives Complete Response Letter for the NDA for BRIXADI™ (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2020-06-01	Braeburn Pharmaceuticals	Braeburn Submits Request for Final Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Opioid Use Disorder braeburnrx.com ↗
2019-11-07	Braeburn Pharmaceuticals	FDA Grants Braeburn’s Citizen Petition Allowing BRIXADI (buprenorphine) Extended-Release Injection for Opioid Use Disorder to be Available in December 2020 braeburnrx.com ↗
2019-07-23	Braeburn Pharmaceuticals	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 braeburnrx.com ↗
2019-06-04	Braeburn Pharmaceuticals	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 braeburnrx.com ↗
2019-04-06	Braeburn Pharmaceuticals	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 braeburnrx.com ↗
2018-12-23	Camurus AB	US FDA issues a tentative approval of Brixadi™ (buprenorphine) extended-release injection for treatment of opioid use disorder camurus.com ↗
2018-12-23	Braeburn Pharmaceuticals	Braeburn Announces Tentative FDA Approval of BRIXADI™ (buprenorphine) Extended-Release Injection for the Treatment of Moderate to Severe Opioid Use Disorder braeburnrx.com ↗
2018-11-28	Camurus AB	Buvidal® Weekly and Buvidal® Monthly (CAM2038) approved in Australia as the first long-acting treatment of opioid dependence camurus.com ↗
2018-11-22	Camurus AB	Camurus receives EU approval for weekly and monthly Buvidal® (CAM2038) for opioid dependence camurus.com ↗
2018-09-21	Camurus AB	CHMP recommends approval of Buvidal® (CAM2038) for the treatment of opioid dependence camurus.com ↗
2018-09-21	Braeburn Pharmaceuticals	CAM2038 Receives Positive CHMP Opinion for the Treatment of Opioid Dependence in Europe braeburnrx.com ↗
2018-09-18	Camurus AB	Camurus announces positive topline Phase 3 results for CAM2038 in opioid experienced patients with chronic low-back pain camurus.com ↗
2018-09-18	Braeburn Pharmaceuticals	Braeburn Announces Positive Top-line Phase 3 Results for CAM2038 in Chronic Low Back Pain Patients Previously on Long-term Daily Opioid Therapy braeburnrx.com ↗
2018-07-16	Camurus AB	Camurus announces PDUFA date for CAM2038 for the treatment of opioid use disorder camurus.com ↗
2018-07-16	Braeburn Pharmaceuticals	Braeburn Announces PDUFA Date for CAM2038 for the Treatment of Opioid Use Disorder braeburnrx.com ↗
2018-06-12	Camurus AB	Camurus and Medison enter into commercialization agreement for CAM2038 in Israel camurus.com ↗
2018-05-28	Camurus AB	Camurus announces NDA resubmission of weekly and monthly buprenorphine depots to FDA camurus.com ↗
2018-05-28	Braeburn Pharmaceuticals	Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder braeburnrx.com ↗
2018-05-14	Camurus AB	JAMA Internal Medicine publishes positive Phase 3 pivotal study results for Camurus’ long-acting buprenorphine depots for opioid use disorder camurus.com ↗
2018-05-14	Braeburn Pharmaceuticals	Braeburn Announces Publication of Positive Phase 3 Results For Long-Acting Buprenorphine For Treatment Of Opioid Use Disorder in JAMA Internal Medicine braeburnrx.com ↗
2018-01-21	Camurus AB	FDA issues complete response letter for CAM2038 for opioid use disorder camurus.com ↗
2018-01-21	Braeburn Pharmaceuticals	Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot braeburnrx.com ↗
2017-11-01	Camurus AB	Camurus announces that FDA advisory committee recommends approval of CAM2038 for treatment of opioid use disorder camurus.com ↗
2017-11-01	Braeburn Pharmaceuticals	Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder braeburnrx.com ↗
2017-10-30	Camurus AB	Camurus announces that FDA has posted briefing material for CAM2038 Advisory Committee meeting camurus.com ↗
2017-09-29	Camurus AB	Camurus announces European Medicines Agency validation of CAM2038 Marketing Authorization Application for treatment of opioid dependence camurus.com ↗
2017-09-18	Camurus AB	Camurus Announces that FDA Grants Priority Review of NDA for Weekly and Monthly CAM2038 Buprenorphine Depots for Treatment of Opioid Use Disorder camurus.com ↗
2017-09-18	Braeburn Pharmaceuticals	FDA Acceptance of NDA for CAM2038 for Opioid Use Disorder braeburnrx.com ↗
2017-07-20	Camurus AB	Camurus and Braeburn Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder camurus.com ↗
2017-07-20	Braeburn Pharmaceuticals	Braeburn and Camurus Announce Submission for CAM2038 for Opioid Use Disorder braeburnrx.com ↗
2017-07-12	Camurus AB	Camurus and Braeburn Pharmaceuticals Announce Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain camurus.com ↗
2017-07-12	Braeburn Pharmaceuticals	Topline Phase 2 Results for Long-acting Buprenorphine in Opioid Dependent Patients with Chronic Pain braeburnrx.com ↗
2017-06-22	Camurus AB	Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms in Adults with Opioid Use Disorder camurus.com ↗
2017-06-22	Braeburn Pharmaceuticals	Long-acting Buprenorphine Blocks Opioid Effects and Suppresses Withdrawal Symptoms braeburnrx.com ↗
2017-06-15	Camurus AB	Camurus and Braeburn Pharmaceuticals Announce Presentations of Pivotal Clinical Study Data of Long-acting Buprenorphine camurus.com ↗
2017-05-02	Camurus AB	Camurus and Braeburn Pharmaceuticals Announce Positive Top-line Results from Long-term Phase 3 Safety Study of CAM2038 camurus.com ↗
2017-05-02	Braeburn Pharmaceuticals	Braeburn and Camurus Announce Positive Top-line Results from CAM2038 Safety Study braeburnrx.com ↗
2016-11-14	Camurus AB	Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Phase 3 Results for Long-acting Buprenorphine for Treatment of Opioid Addiction camurus.com ↗
2016-10-21	Camurus AB	Braeburn Pharmaceuticals and Camurus announce the presentation of new data from clinical studies of long-acting buprenorphine camurus.com ↗
2016-09-30	Camurus AB	Braeburn Pharmaceuticals and Camurus Enroll First Patients in a Phase 3 Efficacy Trial of CAM2038 for treatment of Chronic Low Back Pain camurus.com ↗
2016-05-11	Camurus AB	Braeburn Pharmaceuticals and Camurus announce positive results from Phase 2 opioid challenge study with CAM2038 in subjects with opioid use disorder camurus.com ↗
2016-04-05	Camurus AB	Braeburn Pharmaceuticals and Camurus announce Enrollment goals reached in two pivotal Phase 3 Trials of CAM2038 for treatment of opioid dependence camurus.com ↗
2015-12-15	Camurus AB	Braeburn Pharmaceuticals and Camurus announce start of Phase 3 trial of long-acting buprenorphine treatments for opioid dependence camurus.com ↗
2015-11-04	Camurus AB	FDA grants Fast Track designation for development of CAM2038, long-acting buprenorphine injections to treat opioid addiction camurus.com ↗
2014-11-20	Camurus AB	Camurus and Braeburn Pharmaceuticals sign exclusive license for long-acting buprenorphine injectables for the treatment of opioid dependence and pain camurus.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

Field	Value	Cited text
Known as	CAM2038	ClinicalTrials.gov intervention name — accepted as the source's own label NCT02710526 ↗ 1 NCT04225598 ↗
Known as	buprenorphine	“INTERVENTION: Injection of a 24-mg dose of a weekly extended-release formulation of buprenorphine (CAM2038) and referral for ongoing OUD care.” PMID 38976265 ↗ Jul 2024
Route	Subcutaneous	“subcutaneous administrations of CAM2038” NCT02710526 ↗