When major depressive disorder does not respond to at least two different types of antidepressant treatments in a moderate-to-severe depressive episode, it’s reclassified as treatment-resistant depression (TRD). South San Francisco-based VistaGen Therapeutics’ AV-101 failed to meet the primary efficacy endpoints for TRD in a Phase II clinical trial.
The U.S. FDA approved Johnson & Johnson’s nasal spray antidepressant Spravato for people resistant to other treatments, but placed restrictions on use of the drug.
A U.S. FDA advisory panel voted in favor of J&J’s experimental nasal spray esketamine, which has a compound similar to often-abused ketamine, bringing the drug closer to approval.
Janssen, part of Johnson & Johnson, announced results from two long-term Phase III trials of esketamine nasal spray in patients with treatment-resistant depression.