- June 3, 2018
- Posted by: PharmaScroll
The Janssen Pharmaceutical Companies of Johnson & Johnson announced results from two long-term Phase 3 clinical studies of the investigational compound esketamine nasal spray in patients with treatment-resistant depression. These studies, one that showed a delayed time to relapse and a second that provided evidence of safe long-term use of esketamine, were presented at the Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL.
The first long-term study assessed relapse prevention in adults with treatment-resistant depression. Data from this study showed that continuing treatment with esketamine nasal spray plus an oral antidepressant beyond 16 weeks demonstrated clinically meaningful and statistically significant superiority to treatment with standard of care (oral antidepressant) plus placebo nasal spray in delaying time to relapse of symptoms of depression. The maintenance phase was of variable duration, continuing until the pre-specified number of relapse events was reached.
The results additionally indicated that patients treated with esketamine nasal spray plus an oral antidepressant had a 51% lower risk of relapse than patients in the oral antidepressant plus placebo nasal spray group. Overall, esketamine nasal spray plus an oral antidepressant demonstrated safety and tolerability with repeated, intermittent long-term dosing.
“At least 300 million people worldwide live with treatment-resistant depression, and it is important we continue to study and report the results of studies such as these two1,2,” said Maurizio Fava, MD, Executive Vice Chair of the Massachusetts General Hospital (MGH) Department of Psychiatry and Executive Director of the MGH Clinical Trials Network and Institute (CTNI). “The first study shows that esketamine may be beneficial in terms of extending time to relapse for patients with treatment-resistant depression, and the second provides insights related to its safety over the long-term in this patient population.”
The second study had an open-label design and was the first to assess the long-term safety and efficacy of esketamine nasal spray for up to one year (52 weeks). Data from the study showed that treatment with esketamine nasal spray plus an oral antidepressant was tolerable with no new safety signals after repeated long-term dosing. The safety profile of esketamine in the study was similar to that observed in previous completed short-term Phase 2 and 3 studies in patients with treatment-resistant depression, with a low drop-out rate observed due to adverse events (6.8% in the initial four-week induction phase and 3.8% in the 48-week optimization/maintenance phase).
The data from this open-label study also indicated that treatment with esketamine nasal spray plus an oral antidepressant appeared to be associated with sustained improvement in depressive symptoms at up to 52 weeks. Although this data is derived from an open label, Phase 3 study, whereby both the researchers and study participants knew the treatment the participants received, the efficacy, response and remission rates from the study support data from the relapse prevention study and earlier esketamine studies that were double-blind in design3.
“We are pleased to share these results from our Phase 3 program for esketamine nasal spray. They reinforce its potential to help patients who haven’t responded to available therapies,” said Mathai Mammen, MD, PhD, Global Head, Janssen Research & Development, LLC. “We look forward to submitting all results from our esketamine treatment-resistant depression studies to regulatory authorities, with a view to bringing a new treatment option to people in need.”
If approved by the U.S. Food and Drug Administration (FDA), esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last 50 years.
Janssen has conducted five pivotal Phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression. These clinical studies include three short-term randomized, double-blind, active-controlled studies (fixed dose, flexible dose, and flexible dose study in patients ≥ 65 years), one double-blind randomized withdrawal maintenance of effect study and one open-label long-term safety study. The results from these studies will inform regulatory filings for esketamine nasal spray in treatment-resistant depression.
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News Source: Janssen website
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