In The Spotlight: Avenue Therapeutics

(RTTNews) - Shares of Avenue Therapeutics Inc. (ATXI) have returned an impressive 48% while the iShares Nasdaq Biotechnology ETF (IBB) is up just 6% during the same period.

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.

Tramadol in oral tablet formulation was approved by the FDA way back in 1995. Oral Tramadol is a Schedule IV drug and is widely prescribed in the U.S.

Depending upon a drug's acceptable medical use and its abuse or dependency potential, it is classified into 5 distinct categories or schedules. Schedule I drugs have high abuse potential and no accepted medical use, while Schedule V drugs have very low abuse/dependency potential.

The dual mechanism of action of IV Tramadol delivers opioid efficacy with less abuse potential and low risk of dependence, according to the Company. The IV Tramadol is said to have potentially faster onset of action than oral Tramadol and is suitable for patients who cannot take oral meds.

The IV formulation of Tramadol is available and widely used outside the U.S.

A phase III clinical trial of intravenous (IV) Tramadol for the management of moderate to moderately severe pain in patients following bunionectomy surgery, initiated last September, is ongoing.

This phase III study evaluates the efficacy and safety of IV Tramadol 50 mg and 25 mg versus placebo. The primary efficacy endpoint is the summed pain intensity difference over 48 hours (SPID48) compared to placebo. Top line data from this bunionectomy study is expected in the second quarter of 2018.

A phase III safety trial of IV Tramadol for the management of moderate to moderately severe pain was initiated last December. This trial is designed to evaluate the safety of IV Tramadol 50 mg in the management of postoperative pain following surgery. The safety trial is expected to be completed in the second quarter of 2019.

A second phase III trial of IV Tramadol for the management of moderate to moderately severe pain in patients in patients following abdominoplasty surgery is planned for initiation in the third quarter of 2018.

If all goes well as planned, Avenue Therapeutics will submit its NDA for IV Tramadol by year-end 2019. If approved, IV Tramadol would be the only Schedule IV intravenous opioid medicine in the United States.

Since inception in February 2015, the Company has incurred substantial operating losses, and as of December 31, 2017, had an accumulated deficit of $20.7 million. To date, no revenue has been generated from product sales.

At year-end 2017, the Company had cash of $21.8 million.

Avenue Therapeutics went public on the Nasdaq Capital Market on June 27, 2017, offering its shares at a price of $6.00 each. The stock has thus far hit a low of $3.40 and a high of $8.58.

ATXI closed Wednesday's trading at $5.45, up 14.74%.