Trevena, Inc. Announces Board Changes
Dec 17 14
On December 16, 2014, Farah Champsi provided Trevena, Inc. with notice of her resignation from the Board of Directors of the company, effective as December 16, 2014. At the time of her resignation, Ms. Champsi also was serving on the Audit Committee of the Board and as the Chair of the Nominating and Corporate Governance Committee of the Board. On December 16, 2014, the Board appointed Anne M. Phillips, M.D., as an independent member of the Board, effective as of the same date. Dr. Phillips is expected to serve as a director until the expiration of her term as a Class I director at the Company's 2017 annual meeting of stockholders and also will serve on the Nominating and Corporate Governance Committee of the Board. As a result of Ms. Champsi's departure, the Board also appointed Barbara Yanni to the Audit Committee and named Julie McHugh as the Chair of the Nominating and Corporate Governance Committee. Dr. Phillips currently is Senior Vice President of Clinical, Medical and Regulatory Affairs at Novo Nordisk Inc., where she has served since 2011.
Trevena Announces Positive Results from Phase 2a/b Study of TRV130 in Acute Postoperative Pain
Nov 17 14
Trevena, Inc. announced positive data from its randomized, double-blind, placebo- and active-controlled Phase 2a/b trial of TRV130 in moderate-to-severe postoperative acute pain. At doses of 2 mg and 3 mg TRV130 administered every 3 hours, the study achieved its primary endpoint of statistically greater pain reduction than placebo over 48 hours, successfully demonstrating proof of concept for TRV130. The trial was designed with key secondary endpoints to evaluate the differentiation of TRV130 from gold-standard morphine at a standard reference dose of 4 mg every 4 hours. Over the 48 hour study period, TRV130 3 mg every 3 hours showed statistically superior analgesic efficacy compared to morphine. Additionally, the 2 mg and 3 mg doses of TRV130 demonstrated statistically superior analgesic efficacy compared to 4 mg morphine in the first 3 hours of dosing, when study pain was most severe. For these doses, patients also reported maximum pain relief during the first dosing period that was statistically superior compared to morphine. Notably, in this study TRV130 at 2 mg and 3 mg demonstrated similar tolerability to morphine 4 mg over 48 hours. TRV130 and morphine were both associated with opioid-related adverse events, including dizziness, headache, somnolence, nausea, vomiting, flushing, and itching. Study Results: Success on primary endpoint: Doses of 2 mg and 3 mg of TRV130 at 3 hour intervals achieved a statistically significant reduction in pain intensity difference from placebo over 48 hours, measured as the time-weighted average change in pain score (TWA0-48). At 2 mg, TRV130 reduced average pain score (LS mean change in TWA0-48) by 1.4 points (p=0.0024 vs. placebo; all p-values 1-sided). At 3 mg, TRV130 reduced LS mean TWA0-48 by 2.4 points (p<0.0001 vs. placebo). Baseline pain rating was approximately 7 out of 10, a pain level considered severe. TRV130 achieved a reduction in mean pain intensity of up to approximately 6 points, with notable efficacy at 5 minutes, the first pain intensity assessment after dosing. Over 48 hours, 3 mg of TRV130 at 3 hour intervals achieved a statistically significant reduction in pain intensity difference from 4 mg morphine at 4 hour intervals, reducing average pain score (LS mean change in TWA0-48) by 1.0 point vs. morphine (p=0.014). Morphine reduced LS mean change in TWA0-48 by 1.3 points vs. placebo (p = 0.0023). When study pain was most severe, during the first 3 hours after the initial dose, TRV130 at 1 mg, 2 mg and 3 mg showed a statistically significant reduction in pain (TWA0-3) vs. placebo (LS mean change -1.0, -2.4, and -3.0 respectively; p = 0.021, p < 0.0001, and p < 0.0001, respectively). In addition, TRV130 at 2 mg and 3 mg showed a statistically significant reduction in pain vs. 4 mg morphine during this time (LS mean change: TRV130 2 mg -1.2 vs. morphine, p = 0.0029; TRV130 3 mg -1.8 vs. morphine, p < 0.0001). Consistent with these findings, more patients reported statistically greater peak pain relief during the first dosing period for 2 mg and 3 mg TRV130 compared to 4 mg morphine (p = 0.005 and p < 0.0001 for TRV130 2 mg and 3 mg vs. morphine, respectively). Complete pain relief during this period was reported in 13%, 31%, and 52% of patients receiving 1 mg, 2 mg, and 3 mg TRV130, respectively, compared to 0% and 8% for patients receiving placebo and 4 mg morphine, respectively. Adverse events associated with TRV130 were largely opioid-related; the most frequent reported events were dizziness, headache, somnolence, nausea, vomiting, flushing, and itching. Adverse effects were generally dose-related. No serious adverse events were reported in any study group. Tolerability for 2 mg and 3 mg TRV130 over the full 48 hours of dosing was similar to morphine. Rescue medication (acetaminophen or ketorolac) was used in all groups.