Avenue Therapeutics (ATXI) Hits All-time High, Up 56% So Far This Month

(RTTNews) - Shares of Avenue Therapeutics Inc. (ATXI), which closed at an all-time high of $9.22, have gained 56% so far this month.

Avenue Therapeutics is developing an intravenous formulation of Tramadol HCl, or IV Tramadol, for the management of moderate to moderately severe postoperative pain. An NDA for IV Tramadol was submitted to the FDA on December 11, 2019.

The NDA for IV Tramadol was submitted based on positive results from two pivotal phase III clinical efficacy and safety trials in patients following bunionectomy and abdominoplasty surgeries, as well as an open-label safety study with a total of more than 500 patients who received the IV Tramadol 50 mg dosing regimen.

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 a 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.

Avenue Therapeutics has incurred substantial operating losses since its inception and as of September 30, 2019, had an accumulated deficit of $62.7 million. To date, no revenue has been generated from product sales.

As of September 30, 2019, Avenue's cash and cash equivalents and short-term investments totaled $13.7 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 touched an all-time high of $9.45 in intraday trading on Friday (Dec.27) before closing at $9.15, up 11.31%.