An experimental pill from Axsome Therapeutics had a rapid and significant effect on major depression in pivotal study, the company said Monday, evidence that will support an application for Food and Drug Administration approval.
The treatment, AXS-05, met its goals in a 327-patient trial, outperforming placebo on a measure of depression after one week and sustaining the effect for another five.
On average, patients taking Axsome’s drug charted a 16.6-point improvement on a 60-point scale of depression severity. That was a statistically significant result compared with the 11.9-point benefit seen on placebo. Additionally, about 40% of patients on AXS-05 achieved depression remission after six weeks, a result that also beat placebo.