H.C. Wainwright initiated coverage of Avenue Therapeutics (NASDAQ:ATXI) with a “buy” rating and price target of $11. The stock closed at $3.77 on June 25.
Avenue Therapeutics is focused on the acute care hospital setting, with lead drug, intravenous Tramadol, currently in Phase 3 development for moderate-to-moderately severe post-operative pain.
“Unlike some non-opioid alternatives, IV Tramadol provides, we believe, sufficient pain relief to fill the analgesic gap between IV acetaminophen/NSAIDS for mild-to-moderate pain and widely used conventional narcotics like generic Percocet and Vicodin for severe pain,” writes analyst Ed Arce.
He said IV Tramadol would be highly differentiated as the only IV opioid in the U.S. with a DEA Schedule IV, having previously demonstrated a significantly lower liability for abuse potential and risk of dependence than other opioids, all of which are Schedule II.
Last month, IV Tramadol achieved the primary endpoint and all three key secondary endpoints in a Phase 3 trial of patients following bunionectomy surgery. In the study, IV Tramadol demonstrated rapid pain relief that was well tolerated, with an overall safety profile consistent with known tramadol pharmacology, Mr. Arce said.
In the third quarter of 2018, Avenue expects to initiate its second pivotal Phase 3 trial of IV Tramadol following abdominoplasty surgery, with top-line data expected in the second quarter of 2019 and a 505(b)(2) NDA filing anticipated by the end of 2019. In the second quarter of 2019, Avenue also expects to complete its ongoing safety study.
