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Avenue Therapeutics Announces Positive Topline Phase 3 Data for Intravenous Tramadol in the Management of Postoperative PainIV tramadol achieved primary and key secondary endpoints, as well as a clear dose response Initiation of second pivotal Phase 3 trial planned for third quarter of 2018 Management to host conference call today at 8:30 a.m. EDT NEW YORK, May 21, 2018 (GLOBE NEWSWIRE) -- Avenue Therapeutics, Inc. (NASDAQ:ATXI) (“Avenue”), a company focused on the development and commercialization of intravenous (IV) tramadol, today announced that its first pivotal Phase 3 trial of IV tramadol achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo in patients with moderate to moderately severe postoperative pain following bunionectomy surgery. In addition, the trial met its key secondary endpoints and demonstrated a clear dose response. Avenue plans to initiate a second pivotal Phase 3 trial of IV tramadol in patients following abdominoplasty surgery in the third quarter of 2018. “There is a clear need for new therapies in the postoperative pain setting, where patients are often treated with Schedule II narcotics due to a lack of other options,” said Harold Minkowitz, M.D., an investigator in IV tramadol's Phase 3 program. “IV tramadol, which acts by a dual mechanism, is widely used outside the U.S. in the postoperative setting. These Phase 3 results demonstrate that IV tramadol is well tolerated and rapidly and effectively induces pain relief in patients following bunionectomy surgery, a generally painful procedure, and suggest that IV tramadol could be an important new therapy for managing postoperative pain in our patients.” “We are greatly encouraged by the strong safety and efficacy results from our first Phase 3 trial, which support IV tramadol’s potential to provide an improved IV treatment option for postsurgical pain, and to fill a significant gap between IV NSAIDs and Schedule II opioids,” said Scott Reines, M.D., Ph.D., Avenue’s Chief Medical Officer. “Moreover, the trial clearly defined the 50 mg dose that will be applied in our second Phase 3 trial in patients following abdominoplasty surgery as well as in our ongoing safety trial.” “IV tramadol has the potential to provide a convenient bridge to the widely prescribed oral tramadol. This combination could displace Schedule II narcotics altogether for many patients, and provide a treatment option with less potential for abuse and a lower risk of dependence,” said Lucy Lu, M.D., Avenue’s President and Chief Executive Officer. “We are excited about these results and look forward to initiating a second pivotal Phase 3 trial in the third quarter and, assuming positive data from that study and our ongoing safety trial, we anticipate filing an NDA with the U.S. Food and Drug Administration in late 2019.” Phase 3 Trial Design and Results The Phase 3, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of IV tramadol in 409 patients following bunionectomy surgery. Patients were randomized in a 1:1:1 ratio to a postoperative regimen of 50 mg of IV tramadol, 25 mg of IV tramadol or placebo administered over 15 minutes at hours 0, 2, 4 and once every 4 hours thereafter, for up to 13 doses. Based on a previous pharmacokinetic study, the 50 mg dosing regimen produces a similar Cmax (peak serum concentration) and AUC (area under the curve) to those of 100 mg oral tramadol given every 6 hours at steady state and reaches such Cmax after the third dose at hour 4. The primary endpoint of the bunionectomy study assessed the analgesic efficacy of IV tramadol compared to placebo as measured by SPID48. The key secondary endpoints included SPID24, total consumption of rescue medicine and Patient Global Assessment, which captures patients’ perception of the treatment. The IV tramadol 50 mg treatment arm achieved the primary endpoint of statistically superior improvement in SPID48 (p=0.005) compared to lacebo. The 50 mg arm also met all three key secondary endpoints (p < 0.01). The profile of pain intensity over time demonstrated that IV tramadol 50 mg achieved statistically significant improvement in pain reduction as early as ½ hour (the first assessment timepoint) after dosing. The IV tramadol 25 mg treatment arm generally displayed intermediate results that fell between the 50 mg and the placebo arms, with a dose response observed across each of the primary and key secondary efficacy endpoints. IV tramadol was well-tolerated with no reports of drug-related serious adverse events in the trial. One patient in the 50 mg IV tramadol arm discontinued the trial due to an adverse event (vomiting). The most common (=5%) adverse events in the trial where IV tramadol 50 mg differed from placebo were nausea, vomiting, dizziness and somnolence. However, most of these adverse events were mild or moderate (Grade 1 or 2) with only 4 (3%) patients experiencing a Grade 3 event (vomiting) and no Grade 4 events in the IV tramadol 50 mg group. The overall safety profile of the IV tramadol 50 mg arm is consistent with known tramadol pharmacology and in this trial appeared to have a better tolerability profile than historical data of IV opioids in similar settings, which will be explored in Avenue’s next Phase 3 trial. Detailed trial results will be submitted for presentation at a future scientific conference or for publication in a journal. Conference Call and Webcast About IV Tramadol Avenue is evaluating IV tramadol in a pivotal Phase 3 clinical program: a trial in patients following bunionectomy surgery (NCT03290378) has been completed and a safety study (NCT03395808) is ongoing. A pivotal Phase 3 trial in patients following abdominoplasty surgery is expected to initiate in the third quarter of 2018. About Avenue Therapeutics About Fortress Biotech Forward-Looking Statements Contacts: Investor Relations Jaclyn Jaffe Media Relations |