Relmada’s Phase III Depression Study Scuppered By ‘Placebo Paradox’
Adjunctive Studies Will Continue
Executive Summary
An unexpectedly strong response in the placebo arm has derailed a monotherapy study of Relmada’s investigational antidepressant REL-1017, but the company will continue its trials as an adjunctive therapy.
You may also be interested in...
Relmada Hopes Open-Label Efficacy, Safety Bolster Profile Of Depression Candidate
With a pair of Phase III setbacks due to high placebo response, Relmada reports positive efficacy and safety data from an open-label trial while awaiting data from two ongoing pivotal studies for REL-1017, an NMDA antagonist.
Axsome’s Wait Pays Off With Broad Auvelity Label For Major Depression
After a year-long delay, Axsome gets US FDA approval of bupropion/dextromethorphan combo with broad label for major depression. Firm expects to launch in Q4 with pricing intended for broad patient access.
Sage/Biogen See Big Potential Market For Zuranolone In PPD
The companies reported positive Phase III data in postpartum depression, a market opportunity of up to half a million women in the US with a condition that remains underdiagnosed.