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Janssen has announced its submission of a new drug application to the Food and Drug Administration for esketamine nasal spray, which is intended for adult patients with treatment-resistant depression.
About 30% of people with depression do not respond to currently available interventions (Biol Psychiatry. 2016 Sep 15;80[6]:424-31). “This represents a major unmet public health need,” Mathai Mammen, MD, PhD, global head, Janssen Research & Development, said in a Sept. 4 press release announcing the NDA.
The application submitted by Janssen is based on data from five phase 3 trials, all of which demonstrated rapid reduction of depressive symptoms, as well as delayed time to relapse of symptoms, in patients with treatment-resistant depression, Janssen said in the release. Those studies compared treatment with esketamine plus a newly initiated oral antidepressant with that of placebo plus a newly initiated oral antidepressant. One of the studies evaluated long-term safety associated with esketamine treatment and found no new safety signals at 52 weeks of treatment, compared with those seen in short-term studies of the drug.
Previously, it received Breakthrough Therapy Designations for both treatment-resistant depression and major depressive disorder with imminent risk for suicide. Phase 3 clinical studies for the latter indication are ongoing. According to Janssen, the company plans to submit a Marketing Authorization Application to the European Medicines Agency later in 2018 for the treatment-resistant depression indication.
Janssen has announced its submission of a new drug application to the Food and Drug Administration for esketamine nasal spray, which is intended for adult patients with treatment-resistant depression.
About 30% of people with depression do not respond to currently available interventions (Biol Psychiatry. 2016 Sep 15;80[6]:424-31). “This represents a major unmet public health need,” Mathai Mammen, MD, PhD, global head, Janssen Research & Development, said in a Sept. 4 press release announcing the NDA.
The application submitted by Janssen is based on data from five phase 3 trials, all of which demonstrated rapid reduction of depressive symptoms, as well as delayed time to relapse of symptoms, in patients with treatment-resistant depression, Janssen said in the release. Those studies compared treatment with esketamine plus a newly initiated oral antidepressant with that of placebo plus a newly initiated oral antidepressant. One of the studies evaluated long-term safety associated with esketamine treatment and found no new safety signals at 52 weeks of treatment, compared with those seen in short-term studies of the drug.
Previously, it received Breakthrough Therapy Designations for both treatment-resistant depression and major depressive disorder with imminent risk for suicide. Phase 3 clinical studies for the latter indication are ongoing. According to Janssen, the company plans to submit a Marketing Authorization Application to the European Medicines Agency later in 2018 for the treatment-resistant depression indication.
Janssen has announced its submission of a new drug application to the Food and Drug Administration for esketamine nasal spray, which is intended for adult patients with treatment-resistant depression.
About 30% of people with depression do not respond to currently available interventions (Biol Psychiatry. 2016 Sep 15;80[6]:424-31). “This represents a major unmet public health need,” Mathai Mammen, MD, PhD, global head, Janssen Research & Development, said in a Sept. 4 press release announcing the NDA.
The application submitted by Janssen is based on data from five phase 3 trials, all of which demonstrated rapid reduction of depressive symptoms, as well as delayed time to relapse of symptoms, in patients with treatment-resistant depression, Janssen said in the release. Those studies compared treatment with esketamine plus a newly initiated oral antidepressant with that of placebo plus a newly initiated oral antidepressant. One of the studies evaluated long-term safety associated with esketamine treatment and found no new safety signals at 52 weeks of treatment, compared with those seen in short-term studies of the drug.
Previously, it received Breakthrough Therapy Designations for both treatment-resistant depression and major depressive disorder with imminent risk for suicide. Phase 3 clinical studies for the latter indication are ongoing. According to Janssen, the company plans to submit a Marketing Authorization Application to the European Medicines Agency later in 2018 for the treatment-resistant depression indication.