Braeburn Pharmaceuticals, Inc. develops and commercializes medical products. It develops Probuphine for the treatment of adult patients with opioid dependence. The company also develops and commercializes products for the treatment of schizophrenia and other serious psychiatric disorders. Braeburn Pharmaceuticals, Inc. was founded in 2012 and is based in Princeton, New Jersey.
47 Hulfish Street
Princeton, NJ 08542
Founded in 2012
Braeburn Pharmaceuticals Announces Probuphine Data Published in the Journal of the American Medical Association
Jul 19 16
Braeburn Pharmaceuticals announced that the results of the first comparative trial to evaluate efficacy and safety of a six-month buprenorphine implant relative to sublingual buprenorphine in patients with opioid use disorder were published online on July 19, 2016 in the Journal of the American Medical Association. The study found that participants who were clinically stable on sublingual buprenorphine maintained stability when transferred to the six-month buprenorphine implant, and that they were more likely to sustain abstinence from illicit opioids throughout the six months than participants who remained on sublingual buprenorphine. The study showed that Probuphine was non-inferior to sublingual buprenorphine on the primary endpoint of at least 4 of 6 months with no illicit opioid use by drug testing and self-report among opioid-dependent adults previously stabilized on sublingual buprenorphine. Additionally, relative to participants using sublingual buprenorphine, participants maintained on Probuphine were more likely to sustain abstinence from illicit opioids. At 6 months 85.7% of the Probuphine implant group remained abstinent each month relative to 71.9% of the sublingual buprenorphine group (p=0.03). Non-implant- and implant-related adverse events (AEs) occurred in 48.3% and 23% of the buprenorphine implant group and 52.8% and 13.5% of participants in the sublingual buprenorphine group, respectively. This randomized, double-blind, double-dummy, active-controlled, 26-week, multicenter study in clinically stable adults receiving 8 mg or less sublingual buprenorphine evaluated the safety and efficacy of 4 Probuphine implants compared with daily sublingual buprenorphine in 177 patients. The study was conducted at 21 United States office-based buprenorphine outpatient treatment sites. Eligible participants had a primary diagnosis of Opioid Use Disorder; were aged 18 to 65 years; received sublingual buprenorphine as an outpatient at a stable dose of 8 mg or less and showed no evidence of opioid withdrawal or illicit opioid-positive urine samples for at least 90 days prior to study entry. Primary outcomes: In the buprenorphine implant and sublingual buprenorphine groups, 81/84 (96.4%) and 78/89 (87.6%) of participants, respectively, were responders. The difference was 8.8% (1-sided 97.5% CI, 0.009 to 8; p <0.001 for non-inferiority; p = 0.03 for superiority) on the primary outcome measure vs sublingual buprenorphine. In a sensitivity analysis for all randomized participants, with all missing urine samples imputed as positive and no illicit opioid use for all 6 months, 70/87 (80.5%) participants receiving buprenorphine implants and 60/90 (66.7%) receiving sublingual buprenorphine were abstinent, resulting in a proportion difference of 13.8% (2-sided 95% CI, -0.266 to -0.010; p = 0.038). Additional sensitivity analyses all demonstrated non-inferiority and were consistent with primary efficacy results. Including an analysis by the FDA, that was based on imputation methods and treatment of supplemental use, they determined that Probuphine satisfied the non-inferiority in an evaluation of the proportion of patients with no evidence of illicit opioid use throughout the 6 month period. Probuphine n=55 (63%) versus sublingual n=57 (64%). Secondary outcomes: Relative to sublingual buprenorphine, a larger proportion of participants receiving buprenorphine implants demonstrated no evidence of illicit opioid use throughout 6 months of treatment. At 6 months, cumulative abstinence was 72/84 (85.7%) for buprenorphine implants vs 64/89 (71.9%) for sublingual buprenorphine (hazard ratio [HR] 13.8, 95% CI 0.018–0.258, p = 0.03). This difference became statistically significant starting at month 3 and was sustained throughout month 6. Time to first evidence of illicit opioid use was also significantly longer for buprenorphine implants relative to sublingual buprenorphine (HR 0.49, 95% CI 0.25–0.97, p = 0.04). Serious AEs (SAEs) occurred in 5 participants; 3 in the sublingual buprenorphine group (biliary colic, chronic cholecystitis, bronchitis) and 2 in the buprenorphine implant group (convulsions, worsening bipolar I disorder). One buprenorphine implant participant discontinued due to an AE (muscle spasms). Medication-related and implant-related AEs were consistent with the known safety profile of buprenorphine and the previously published implantation procedure. Buprenorphine implants were associated with higher incidences of local site AEs vs. sublingual buprenorphine. There were no cases of migration of implants beyond the local insertion site.
Braeburn Pharmaceuticals, Inc. Presents at Cantor Fitzgerald 2nd Annual Healthcare Conference, Jul-13-2016 08:00 AM
Jul 7 16
Braeburn Pharmaceuticals, Inc. Presents at Cantor Fitzgerald 2nd Annual Healthcare Conference, Jul-13-2016 08:00 AM. Venue: Le Parker Meridien, New York, New York, United States.
Braeburn Pharmaceuticals Announces FDA Approves Probuphine® (buprenorphine) Implant: The First Implant for Treatment of Opioid Dependence
May 26 16
Braeburn Pharmaceuticals announced that the U.S. Food & Drug Administration (FDA) approved Probuphine, the first implant for the maintenance treatment of opioid dependence in patients who have sustained clinical stability on low-to-moderate doses of buprenorphine, specifically 8 mg or less per day. Probuphine delivers buprenorphine continuously for up to six months and should be used as part of a complete treatment program to include counseling and psychosocial support.