Relmada Therapeutics Inc. shares more than doubled after a mid-stage study showed that two doses of its treatment-resistant depression drug REL-1017 improved symptoms of the disorder compared to placebo.
Relmada's stock price jumped 128.25% to $25.45 as of 1:44 p.m. ET on Oct. 15. The shares closed the previous day at $11.15.
The New York-based pharmaceutical company studied a seven-day regimen of 25- and 50-milligram doses of REL-1017, or dextromethadone, for efficacy and tolerability in the phase 2 trial. The improvement in depression symptoms appeared on the fourth day and continued until a week after the treatment was stopped, Relmada said in an Oct. 15 press release.
Patients with treatment-resistant depression show a lack of response to at least two different antidepressant treatments.
Treatment-resistant depression has seen a boom in drug development in recent years. The U.S. Food and Drug Administration approved Johnson & Johnson's esketamine nasal spray Spravato for the condition in March. It was the first treatment-resistant depression therapy approved since Eli Lilly and Co. launched Symbyax in 2009. Symbyax is a single-pill combination of fluoxetine, or Prozac, and olanzapine, or Zyprexa — both brand name drugs manufactured individually by Lilly.
Allergan PLC, Sage Therapeutics Inc. and VistaGen Therapeutics Inc. are among companies developing medications for depression. Cambridge, Mass.-based Sage shifted its focus from bipolar depression to treatment-resistant depression after a late-stage analysis showed that its experimental drug Sage-217 elicited a rapid response in patients who had seen no previous effect with one antidepressant therapy.
The FDA granted fast-track designation to REL-1017 in April 2017 as an additional treatment for major depressive disorder, which the World Health Organization considers a leading cause of disability worldwide.