No Pain, All Gain For Avenue Therapeutics…

(RTTNews) - Investors of Avenue Therapeutics Inc. (ATXI) have a reason to smile today, as the shares are up over 30% in pre-market trading.

Avenue Therapeutics is focused on the development and commercialization of an intravenous, or IV, formulation of Tramadol HCl, or IV Tramadol, for the management of moderate to moderately severe postoperative pain.

The Company has announced positive top line phase III data for intravenous Tramadol in the management of postoperative pain in patients following bunionectomy surgery.

In the phase III study, the efficacy and safety of IV Tramadol 50 mg and 25 mg versus placebo in 409 patients following bunionectomy surgery was evaluated. The study achieved the primary endpoint of a statistically significant improvement in Sum of Pain Intensity Difference over 48 hours compared to placebo.

In addition, the trial met its key secondary endpoints and demonstrated a clear dose response, according to the Company.

Now that positive results have been achieved in the first pivotal study in patients following bunionectomy surgery, the Company is planning to initiate its second phase III trial in patients following abdominoplasty surgery in the third quarter of 2018.

If all goes well as planned, the Company anticipates filing an NDA for for intravenous Tramadol with the FDA in late 2019.

ATXI closed Friday's trading at $4.25, down 2.30%. In pre-market trading on Monday, the stock is up 31.76% to $5.60.

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