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The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of January 19, 2018. If approved, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg) and once monthly (64 mg to 160 mg) subcutaneous injections. Braeburn Pharmaceuticals is ready to give its opioid use disorder (OUD) therapy another shot at the market. CAM2038 is an investigational buprenorphine weekly and monthly depot subcutaneous injection for the treatment … Braeburn Pharmaceuticals: ClinicalTrials.gov Identifier: NCT02651584 Other Study ID Numbers: HS-11-421 : First Posted: January 11, 2016 Key Record Dates: Results First Posted: August 22, 2019: Last Update Posted: August 22, 2019 Last Verified: August 2018 … If approved, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg) and once monthly (64 mg to 160 mg) subcutaneous injections. . Braeburn Pharmaceuticals’ CAM2038, an investigational buprenorphine treatment, is designed for adults with an opioid use disorder. Camurus (PRNewsFoto/Braeburn Pharmaceuticals) Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support PRINCETON, New Jersey and LUND, Sweden, November 14, 2016 /PRNewswire/ -- - Head-to-head Study of CAM2038 Versus Daily Sublingual Buprenorphine - CAM2038 … Bloomberg the Company & Its Products Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Terminal Demo Request About Braeburn Pharmaceuticals Regulatory News: Braeburn Pharmaceuticals and Camurus (STO:CAMX) today announce that the enrollment goals for both the 24-week efficacy study and the 48-week safety study were met on Braeburn Resubmits New Drug Application for CAM2038 for Opioid Use Disorder: Jan 21, 2018: Braeburn Receives Complete Response Letter for CAM2038 Injectable Buprenorphine Depot: Nov 1, 2017: Braeburn Announces FDA Advisory Committee Recommends Approval of CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder: Sep 18, 2017 About Braeburn Pharmaceuticals The US Food and Drug Administration (FDA) has replied with a complete response letter (CRL) for CAM2038 (Braeburn Pharmaceuticals), a long-acting subcutaneous injection of buprenorphine for … Camurus (NASDAQ STO: CAMX) and Braeburn Pharmaceuticals today announced positive top-line results from a long-term Phase 3 trial supporting the safety and efficacy of CAM2038 (weekly and monthly buprenorphine depots) in patients with moderate-to-severe opioid use disorder. Braeburn Pharmaceuticals and Camurus announce positive top line results from Phase 2 opioid challenge study with CAM2038 in subjects with opioid use … Share. Braeburn Pharmaceuticals Inc. (Plymouth Meeting, Pa.) said FDA granted “tentative” approval to Brixadi buprenorphine (CAM2038) extended-release weekly and monthly injections to treat moderate-to-severe opioid use disorder. Braeburn Pharmaceuticals and Camurus Announce Positive Top-line Phase 3 Results for Long-acting Buprenorphine (CAM2038) for Treatment of Opioid Addiction . The resubmission is in response to the Complete Response Letter issued by the U.S. Food and Drug Administration in January requesting additional information without the need […] If approved by the US Food and Drug Administration (FDA), CAM2038 will be part of a broad treatment plan that includes psychosocial support and counseling. 02.05.2017 – 10:06. Braeburn Pharmaceuticals, an Apple Tree Partners company, is a commercial-stage pharmaceutical company delivering individualized medicine in neuroscience. PRINCETON, NJ, USA and LUND, Sweden I September 30, 2016 I Braeburn Pharmaceuticals and Camurus announce that the first patients have been enrolled in the randomized, double-blind, placebo-controlled Phase 3 efficacy and safety trial of CAM2038 in patients with moderate to severe chronic low back pain that are currently being treated with opioids. About Braeburn Pharmaceuticals Braeburn is a pharmaceutical company dedicated to delivering solutions for people living with the serious, often fatal consequences of opioid addiction. Braeburn Pharmaceuticals and Camurus presented data from three clinical studies on CAM2038, an investigational injectable medication administered to opioid use disorder participants, at the annual meeting of the International Society of Addiction Medicine and the Canadian Society of Addiction Medicine ().. Braeburn has also applied for Priority Review which, if granted, could shorten the review process of CAM2038 following the FDA's acceptance of the NDA. Braeburn Pharmaceuticals and Camurus announce positive top line results from Phase 2 opioid challenge study with CAM2038 in subjects with opioid use disorder Braeburn recently raised $110 million in preparation for the market release of CAM2038. Princeton, New Jersey and Lund, Sweden — September 30, 2016 — Braeburn Pharmaceuticals and Camurus announce that the first patients have been enrolled in the randomized, double-blind, placebo-controlled Phase 3 efficacy and safety trial of CAM2038 in patients with moderate to severe chronic low back pain that are currently being treated with opioids. "These new Phase 3 results add to the growing body of evidence supporting the use of our weekly and monthly … The FDA’s Drug Safety and Risk Management Advisory Committee and the … About CAM2038. If approved, CAM2038 will be offered in dosage strengths for once weekly (8 mg to 32 mg) and once monthly (64 mg to 160 mg) subcutaneous injections. CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. 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). Camurus and Braeburn Pharmaceuticals Announce Positive Top-line Results from Phase 3 Safety Study of CAM2038 After receiving a Complete Response Letter (CRL) for investigative long-acting subcutaneous buprenorphine injection CAM2038 in late January, Braeburn has announced its New Drug Application (NDA) resubmission for the drug’s indication to treat patients with OUD. CAM2038 is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional. New data support long-term safety and efficacy of weekly and monthly subcutaneous buprenorphine depots in patients with opioid use disorder. The three scientific presentations include: CAM2038 is stored at room temperature, hence avoiding the need for cold chain distribution and refrigerator storage, which most healthcare provider offices do not have. Regulatory News: Braeburn Pharmaceuticals and Camurus (STO:CAMX) today announce top line results of a multiple-dose, pivotal Phase 2 study assessing the blockade by CAM2038 of subjective News from the Group: Camurus and Braeburn Pharmaceuticals announce positive Top-line results from long-term Phase 3 safety study of CAM2038. About Braeburn Pharmaceuticals Braeburn Pharmaceuticals, Inc. (Braeburn) ... CAM2038 was accepted under Priority Review designation by the FDA in September 2017 and previously granted Fast Track designation. On 2 May 2017 Camurus (NASDAQ STO:CAMX) and Braeburn Pharmaceuticals announced positive top-line results … One of the frontrunners in the rush to get new opioid addiction treatments to the market has just hit a roadblock. Camurus. Bloomberg the Company & Its Products The Company & its Products Bloomberg Terminal Demo Request Bloomberg Anywhere Remote Login Bloomberg Anywhere Login Bloomberg Customer Support Customer Support As CAM2038 is provided ready for use in a prefilled syringe, no mixing steps or room temperature conditioning is required. Princeton, New Jersey and Lund, Sweden — 14 November 2016 — America’s opioid crisis is taking the life of a person every 19 minutes. Regulatory News: Head-to-head study of CAM2038 versus daily sublingual buprenorphine CAM2038 met both FDA and EMA primary endpoints of non-inferiority. 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