Brixadi once-weekly depot (buprenorphine once-weekly depot) / Braeburn, Camurus - LARVOL DELTA

MOMs-CMA: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (clinicaltrials.gov) - P3 | N=97 | Active, not recruiting | Sponsor: T. John Winhusen, PhD | Recruiting ➔ Active, not recruiting | N=200 ➔ 97

Enrollment change • Enrollment closed • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Once-weekly or once-monthly subcutaneous buprenorphine (Brixadi) for opioid use disorders. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Addiction (Opioid and Alcohol) • Substance Abuse

FDA Approves New Buprenorphine Treatment Option for Opioid Use Disorder (PRNewswire) - "Today, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended-release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine."

sNDA • Addiction (Opioid and Alcohol) • CNS Disorders

MOMs: Medication Treatment for Opioid Use Disorder in Expectant Mothers (clinicaltrials.gov) - P3 | N=140 | Active, not recruiting | Sponsor: T. John Winhusen, PhD | Recruiting ➔ Active, not recruiting | N=200 ➔ 140

Enrollment change • Enrollment closed • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2 | N=2630 | Recruiting | Sponsor: NYU Langone Health | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jul 2026

Trial completion date • Trial primary completion date • Substance Abuse

MOMs: Medication Treatment for Opioid Use Disorder in Expectant Mothers (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: T. John Winhusen, PhD | Trial completion date: Sep 2026 ➔ Dec 2024 | Trial primary completion date: Sep 2025 ➔ Dec 2024

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

MOMs-CMA: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: T. John Winhusen, PhD | Trial completion date: Sep 2026 ➔ Dec 2024 | Trial primary completion date: Sep 2025 ➔ Dec 2024

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

MOMs-INO: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (clinicaltrials.gov) - P3 | N=200 | Recruiting | Sponsor: T. John Winhusen, PhD | Trial completion date: Sep 2026 ➔ Dec 2024 | Trial primary completion date: Sep 2026 ➔ Dec 2024

Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Braeburn receives new Complete Response Letter for Brixadi in the US (Market Screener) - "Camurus AB...today announced that its US licensee Braeburn has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its updated New Drug Application (NDA) for Brixadi(TM) (buprenorphine) extended-release injections for the treatment of opioid use disorder. The CRL is a result of continued quality related deficiencies at Braeburn's US based third party manufacturer, identified by the FDA during a pre-approval inspection....Camurus will provide further updates as soon as additional relevant information has been received from Braeburn."

FDA event • Addiction (Opioid and Alcohol) • CNS Disorders

The European Medicines Agency accepts application to extend the Buvidal indication to include treatment of chronic pain (Cision) - "Camurus...today announces that the European Medicines Agency (EMA) has accepted the company’s submission of a Type II variation application for Buvidal® (buprenorphine) prolonged release injection to include treatment of chronic pain....The regulatory submission is supported by results from a...Phase 3 efficacy and safety study of CAM2038 in patients with moderate to severe chronic low back pain treated with opioid pain medications for a minimum of 3 months prior to study enrollment....A regulatory approval decision is expected in the second half of 2022."

European regulatory • Back Pain • CNS Disorders • Lumbar Back Pain • Pain

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2; N=2630; Recruiting; Sponsor: NYU Langone Health; Trial completion date: Feb 2026 ➔ Jun 2026

Trial completion date • Substance Abuse

MOMs: Medication Treatment for Opioid Use Disorder in Expectant Mothers (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: T. John Winhusen, PhD; Trial completion date: Dec 2026 ➔ Sep 2026; Trial primary completion date: Dec 2025 ➔ Sep 2025

Clinical • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

MOMs-CMA: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Conceptual Model Assessments Sub-study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: T. John Winhusen, PhD; Trial completion date: Dec 2026 ➔ Sep 2026; Trial primary completion date: Dec 2025 ➔ Sep 2025

Clinical • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

MOMs-INO: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: T. John Winhusen, PhD; Trial completion date: Dec 2027 ➔ Sep 2026; Trial primary completion date: Dec 2026 ➔ Sep 2026

Clinical • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Buprenorphine (CAM2038) in Subjects With a Recent History of Moderate to Severe Chronic Low Back Pain (clinicaltrials.gov) - P3; N=1053; Completed; Sponsor: Braeburn Pharmaceuticals; N=676 ➔ 1053

Clinical • Enrollment change • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

MOMs-INO: Medication Treatment for Opioid Use Disorder in Expectant Mothers: Infant Neurodevelopmental Outcomes Sub-study (clinicaltrials.gov) - P3; N=200; Recruiting; Sponsor: T. John Winhusen, PhD; Not yet recruiting ➔ Recruiting; N=300 ➔ 200

Clinical • Enrollment change • Enrollment open • Addiction (Opioid and Alcohol) • CNS Disorders • Psychiatry • Substance Abuse

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2; N=2630; Recruiting; Sponsor: NYU Langone Health; Not yet recruiting ➔ Recruiting

Enrollment open • Substance Abuse

Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD) (clinicaltrials.gov) - P2; N=2630; Not yet recruiting; Sponsor: NYU Langone Health; Phase classification: P4 ➔ P2; N=1630 ➔ 2630

Enrollment change • Phase classification

Camurus CEO on FDA announcement: 'A temporary setback' [Google translation] (Dagens industri) - "...The Camurus CAMX -2.55% state that the FDA recently conducted an inspection of the contract manufacturer that the licensing partner Braeburn uses for Brixadi in the US and discovered quality deficiencies....Camurus had expected to receive such market approval yesterday, December 1."

FDA event • Back Pain • CNS Disorders • Musculoskeletal Pain • Pain

Prolonged-release buprenorphine formulations: Perspectives for clinical practice (PubMed, Therapie) - "Buprenorphine and methadone are the two main opioids agonist treatments approved for opioid use disorder...Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties..."

Clinical • Journal • Addiction (Opioid and Alcohol) • Pain

Prolonged-release buprenorphine formulations: Perspectives for clinical practice. (PubMed, Therapie) - "Buprenorphine and methadone are the two main opioid agonist treatments approved for opioid use disorder...Sixmo®/Probuphine® is a six-month-long implant which needs to be surgically placed and removed and is approved for subjects previously treated with a maximum daily dose of 8mg of sublingual buprenorphine, and can be used only for two successive periods of six months before the subject needs to be switched back to sublingual form. Sublocade® is a one-month-long depot formulation that is indicated in switch from sublingual buprenorphine, and which proposes only two dose schemes, i.e., 100 and 300mg monthly. Buvidal®/Brixadi® is a one-week- or one-month-long depot formulation with multiple dosages, which can be used in initiation or in switched from sublingual formulations. While opioid users report some concerns with a risk of coercive use of long-acting forms of buprenorphine, both users and professionals deem that these new specialties could..."

Clinical • Journal • Addiction (Opioid and Alcohol) • Pain

Camurus announces submission of request for final approval of Brixadi for the treatment of opioid use disorder in the US (PRNewswire) - "Camurus AB...today announces that the company's US partner Braeburn has submitted a request for final approval of Brixadi™ (buprenorphine) weekly and monthly extended release injection for the treatment of opioid use disorder to the US Food and Drug Administration (FDA)....Brixadi was not eligible for marketing in the US because of an exclusivity period expiring on 30 November 2020. With today's request, Braeburn has submitted all updates for a final approval decision in the US on 1 December 2020."

Commercial • Addiction (Opioid and Alcohol) • CNS Disorders

Braeburn announces completion of $110 million financing (PRNewswire) - "Braeburn will use the proceeds to continue to advance the FDA approval process, and commercialize CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with OUD."

Financing • Addiction (Opioid and Alcohol) • CNS Disorders

FDA takes new steps to advance the development of innovative products for treating opioid use disorder (PRNewswire) - “The U.S. Food and Drug Administration announced today the latest action to encourage and support the development of treatment options for people with opioid use disorder (OUD)….The first guidance, released today, explains the FDA's current thinking about drug development and clinical trial design issues relevant to the study of sustained-release 'depot' buprenorphine products (i.e., modified-release products for injection or implantation).”

Regulatory • Addiction (Opioid and Alcohol) • CNS Disorders

Braeburn announces FDA acceptance with Priority Review of New Drug Application for CAM2038 buprenorphine depot for the treatment of opioid use disorder (PRNewswire) - "Braeburn Pharmaceuticals, Inc. (Braeburn) announces that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) with Priority Review designation for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder (OUD)....FDA has granted Fast Track and Priority Review designations for CAM2038...and will convene an Advisory Committee meeting for CAM2038 in Q4 2017. Additionally, FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 19, 2018."

NDA • PDUFA date • Addiction (Opioid and Alcohol) • CNS Disorders