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LONDON, UK / ACCESSWIRE / May 23, 2018 / If you want access to our free research report on Avenue Therapeutics, Inc. (NASDAQ: ATXI), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ATXI as the Company's latest news hit the wire. On May 21, 2018, the Company announced that its first pivotal Phase-3 trial assessing IV tramadol for treatment of patients with moderate to moderately severe postoperative pain following bunionectomy surgery achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours (SPID48) compared to placebo. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Phase-3 Trial Evaluating IV Tramadol Patients to Begin in Q3 2018
The Phase-3 trial met its key secondary endpoints and demonstrated a clear dose response. The Company plans to initiate a second pivotal Phase-3 trial of IV tramadol in patients following abdominoplasty surgery in Q3 2018.
IV Tramadol was Well-Tolerated with No Reports of Drug-Related Serious Adverse Events
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. The IV tramadol 50 mg treatment arm achieved the primary endpoint of statistically superior improvement in SPID48 compared to placebo. The 50 mg arm also met all three key secondary endpoints. 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 after dosing.
IV tramadol was well-tolerated with no reports of drug-related serious adverse events in the trial. The most common adverse events in the trial where IV tramadol 50 mg differed from placebo were nausea, vomiting, dizziness, and somnolence. Detailed trial results will be submitted for presentation at a future scientific conference or for publication in a journal.
Avenue Anticipates Filing an NDA with the US Food and Drug Administration in Late 2019
Lucy Lu, M.D., President and Chief Executive Officer of Avenue, stated that 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.
Lucy added that the Company is happy about these results and looks forward to initiating a second pivotal Phase-3 trial in the third quarter and, assuming positive data from that study and its ongoing safety trial, Avenue anticipates filing an NDA with the US FDA in late 2019.
Post the announcement of the news, shares of the Company surged in pre-market trade.
About IV Tramadol
Tramadol is a synthetic, dual-acting opioid with a unique mechanism of action that delivers opioid efficacy with less potential for abuse and a lower risk of dependence than conventional narcotics. Oral tramadol has a well-established efficacy and safety profile and is currently approved and marketed in the US for moderate to moderately severe pain in adults. There is currently no approved IV formulation in the US.
About Avenue Therapeutics, Inc.
Headquartered in New York City, New York, Avenue Therapeutics is a specialty pharmaceutical company focused on the development and commercialization of intravenous (IV) tramadol for the management of moderate to moderately severe postoperative pain.
Stock Performance Snapshot
May 22, 2018 - At Tuesday's closing bell, Avenue Therapeutics' stock tumbled 12.22%, ending the trading session at $3.59.
Volume traded for the day: 134.26 thousand shares, which was above the 3-month average volume of 38.14 thousand shares.
After yesterday's close, Avenue Therapeutics' market cap was at $37.77 million.
The stock is part of the Healthcare sector, categorized under the Drug Manufacturers-Other industry.
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