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Braeburn and Camurus Announce Submission of NDA for Long-Acting Buprenorphine (CAM2038) for Opioid Use Disorder | ||||||||
By: PR Newswire Association LLC. - 20 Jul 2017 | Back to overview list |
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PRINCETON, N.J. and LUND, Sweden, July 20, 2017 /PRNewswire/ -- Braeburn Pharmaceuticals ("Braeburn") and Camurus (NASDAQ STO: CAMX) today announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of the companies' weekly and monthly buprenorphine depots (CAM2038) to treat Opioid Use Disorder. 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. "Opioid addiction is an overwhelming public health epidemic in the U.S. Current daily medications for this condition are effective when taken as prescribed; however, for many patients, this can be a real challenge. Patients who do not take their medication as prescribed are ten times more likely to relapse1," said Mike Derkacz, President and CEO of Braeburn Pharmaceuticals. "If approved, patients will have access to a weekly and monthly dosing option that allows for flexible and individualized treatment from initiation on day one and throughout their recovery. This reduces the burden of daily medication, as well as the risks of misuse and diversion." The NDA submission for CAM2038 includes data from a comprehensive global clinical development program, evaluating 944 study participants across seven clinical trials:
"Since the completion of our comprehensive clinical program for CAM2038, we have worked relentlessly to finalize our regulatory submissions to make these potentially treatment-transforming investigational medicines available to patients with Opioid Use Disorder," said Fredrik Tiberg, President and CEO, Camurus. "We are deeply appreciative of the important contributions of our investigators, nurses, and study participants, as well as the tireless efforts of our teams at Braeburn and Camurus, making this important milestone a truly collective achievement." Pivotal Phase 3 Study Versus Active Comparator Non-inferiority was demonstrated for both primary endpoints of non-inferiority between CAM2038 and SL BPN/NX, with a positive treatment difference of 3.4% (95% CI: -3.5–10.4%; P<0.001) for responder rate and 6.7% (95% CI: -0.1–13.6%; P<0.001) for the mean percent opioid-negative urine samples. Subsequently, following the prespecified test-order, superiority of CAM2038 versus daily SL BPN/NX was demonstrated for the CDF for the percentage of illicit opioid-negative urines plus self-reports during treatment weeks 4–24 (P=0.004). The safety profile of CAM2038 was generally consistent with the known safety profile of buprenorphine, with the exception of mild-to-moderate injection-site adverse events. Of the 428 enrolled patients, 128 (60.1%) in the CAM2038 group and 119 (55.3%) in the SL BPN/NX group experienced at least one adverse event, of which 70 (32.9%) and 64 (29.8%), respectively, were treatment related. Serious adverse events were reported for 5 (2.3%) of CAM2038 patients and 13 (6%) of SL BPN/NX patients. Injection site related adverse reactions were observed after 5.0% of the administered injections and in 36 (16.9%) of the 213 patients in the CAM2038 treatment group. The most common adverse reactions were injection site pain (8.9%), injection site pruritus (6.1%) and injection site erythema (4.7%). The injection site reactions were mild (78%) or moderate (22%) in severity. No serious injection site events were reported. Five cases of non-fatal drug overdoses were reported in the study (four were accidental: 3 heroin and 1 clonazepam, and one was intentional); all of which occurred in the SL BPN/NX group. Top-line data was announced in November 2016, with further highlights presented at the annual scientific meeting of the College on Problems of Drug Dependence (CPDD) last month. Full results from the study will be presented in a scientific publication. About CAM2038 Investigational Products CAM2038 depots are presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional as small dose volume (about 0.6 mL) subcutaneous injection through a thin, 23-gauge needle. CAM2038 is developed for room temperature storage, avoiding the need for cold chain distribution and refrigerator storage. No mixing steps or room temperature conditioning are required prior to administration. The suite of products include dosage strengths for the once weekly that range from 8 mg to 32 mg, the once monthly injectable includes dosage strengths that range from 64 mg to 160 mg. About Opioid Dependence About Braeburn Pharmaceuticals About Camurus For additional information, please contact: For Camurus: Fredrik Tiberg, President & CEO Rein Piir, VP Investor Relations For Braeburn Pharmaceuticals: Sherry Feldberg, MSLGROUP Boston
View original content with multimedia:http://www.prnewswire.com/news-releases/braeburn-and-camurus-announce-submission-of-nda-for-long-acting-buprenorphine-cam2038-for-opioid-use-disorder-300491241.html SOURCE Braeburn Pharmaceuticals |
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Copyright 2017 PR Newswire Association LLC. | Back to overview list |