Axsome’s late-stage study of experimental depression drug misses main trial goal
pharmafile | March 31, 2020 | News story | Manufacturing and Production | Depressive Disorder, MDD, depression, migraine
Axsome Therapeutics reported on Monday that its Phase 3 study of its experimental depression drug missed its main trial goal.
It’s drug AXS-05 (dextromethorphan/bupropion) failed to significantly improve depression symptoms compared to bupropion, in patients with treatment-resistant depression (TRD). However this treatment for people with major depressive disorder (MDD) remains on track in its trial phase.
The STRIDE-1 study, containing 156 people, targeted patients with MDD who had previously failed one or two antidepressant treatments, and they were given bupropion twice daily during a six week period. Those who failed to respond to this were randomized for treatment with either bupropion at the same dosage or two doses of AXS-05.
Top line results showed that AXS-05 led to a greater improvement on the Montgomery-Asberg Depression Rating Scales after six weeks of treatment, with a rating of 11.6 for the drug compared to 9.4 for bupropion. However, the drug led to a significant 3.3 reduction from baseline in the Quick Inventory of Depressive Symptomatology-Self-Rated (QIDS-SR-16) total score over the entire six-week treatment period, versus a 2.3 reduction for bupropion.
Axsom Chief Executive Officer, Herriot Tabutea, commented on the results and said: “Although the primary endpoint did not reach statistical significance, we are encouraged by the overall results as they continue to demonstrate a rapid, statistically significant onset of action for AXS-05 which, in this study, has translated through to even the most difficult-to-treat population. Support the continued development of AXS-05 in TRD, and initiation of a second Phase III trial in this indication is anticipated in the third quarter.”
The drug was well tolerated with the worst side effects being dizziness and nausea. There were three serious cases of adverse reactions consisting of migraine, overdose and suicidal ideation, which occurred a week after the treatment finished.
Conor Kavanagh
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