FDA News

Janssen seeks FDA approval for esketamine nasal spray

Husseini K. Manji, MD
Husseini K. Manji

Janssen has submitted a New Drug Application to the FDA for esketamine nasal spray for treatment-resistant depression in adults, according to a press release.

Esketamine nasal spray has previously shown beneficial evidence for patients with major depression. In addition, study findings presented earlier this year at the American Psychiatric Association annual meeting revealed that esketamine nasal spray shows potential in treatment-resistant depression.

Data from five phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression showed that treatment with esketamine nasal spray plus an oral antidepressant compared with placebo nasal spray plus an antidepressant was linked to rapid reduction of depressive symptoms and delayed time to relapse of symptoms, the release said. One study, which measured the long-term safety profile, demonstrated that the esketamine doses examined were generally tolerated, with no new safety signals observed with dosing up to 52 weeks.

If approved, patients will be able to administer esketamine nasal spray under health care professional supervision, according to the release.

"Esketamine has been shown to target critical aspects of glutamate-mediated synaptic plasticity, thereby bringing about rapid and sustained improvement in people with treatment-resistant depression," Husseini K. Manji, MD, global head, neuroscience therapeutic area, Janssen Research & Development LLC, said in the press release.

Previously, the FDA granted Breakthrough Therapy Designation for esketamine nasal spray for treatment-resistant depression, the press release said. The FDA has also granted a second indication for major depressive disorder with imminent risk for suicide, for which Janssen is currently conducting phase 3 clinical studies. Later this year, Janssen plans to submit a Marketing Authorization Application to the European Medicines Agency for the esketamine treatment-resistant depression indication.

Husseini K. Manji, MD
Husseini K. Manji
 

Janssen has submitted a New Drug Application to the FDA for esketamine nasal spray for treatment-resistant depression in adults, according to a press release.

Esketamine nasal spray has previously shown beneficial evidence for patients with major depression. In addition, study findings presented earlier this year at the American Psychiatric Association annual meeting revealed that esketamine nasal spray shows potential in treatment-resistant depression.

Data from five phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression showed that treatment with esketamine nasal spray plus an oral antidepressant compared with placebo nasal spray plus an antidepressant was linked to rapid reduction of depressive symptoms and delayed time to relapse of symptoms, the release said. One study, which measured the long-term safety profile, demonstrated that the esketamine doses examined were generally tolerated, with no new safety signals observed with dosing up to 52 weeks.

If approved, patients will be able to administer esketamine nasal spray under health care professional supervision, according to the release.

"Esketamine has been shown to target critical aspects of glutamate-mediated synaptic plasticity, thereby bringing about rapid and sustained improvement in people with treatment-resistant depression," Husseini K. Manji, MD, global head, neuroscience therapeutic area, Janssen Research & Development LLC, said in the press release.

Previously, the FDA granted Breakthrough Therapy Designation for esketamine nasal spray for treatment-resistant depression, the press release said. The FDA has also granted a second indication for major depressive disorder with imminent risk for suicide, for which Janssen is currently conducting phase 3 clinical studies. Later this year, Janssen plans to submit a Marketing Authorization Application to the European Medicines Agency for the esketamine treatment-resistant depression indication.