J&J: FDA approves Janssen's nasal spray for depression
(CercleFinance.com) - Yesterday the Food and Drug Administration approved Janssen's nasal spray Spravato against depression, marking the first such US regulatory approval in decades.
The FDA has approved the esketamine-based drug for use in conjunction with an oral antidepressant in adults with treatment-resistant depression, the Johnson & Johnson unit said.
In a Phase 3 clinical trial that had enrolled over 1,700 adults, patients taking Spravato who continued treatment with the medicine were 51% less likely to relapse, versus those who maintained a regimen of a placebo and an oral antidepressant.
This is the first FDA approval of esketamine for any use. The FDA approved ketamine in 1970.
Copyright (c) 2019 CercleFinance.com. All rights reserved.
The FDA has approved the esketamine-based drug for use in conjunction with an oral antidepressant in adults with treatment-resistant depression, the Johnson & Johnson unit said.
In a Phase 3 clinical trial that had enrolled over 1,700 adults, patients taking Spravato who continued treatment with the medicine were 51% less likely to relapse, versus those who maintained a regimen of a placebo and an oral antidepressant.
This is the first FDA approval of esketamine for any use. The FDA approved ketamine in 1970.
Copyright (c) 2019 CercleFinance.com. All rights reserved.