Update (September 17, 2018): Janssen has now submitted an application for approval to the FDA for esketamine nasal spray for treatment-resistant depression. Data from five Phase III studies were used to support their regulatory application.
Originally published on June 5, 2018:
Johnson & Johnson’s pharmaceutical arm, Janssen, has released data from two late-stage clinical trials of their treatment-resistant depression drug esketamine. The nasal spray was shown to be safe for long-term use in this patient population, with the second study providing evidence that it could delay the time to relapse. Both studies were presented at the Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP) last week.
In Janssen’s Phase III relapse prevention study, 705 adult patients with treatment-resistant depression were enrolled. Patients taking the standard of care – an oral antidepressant – combined the esketamine nasal spray beyond the 16-week study period showed a delayed time to relapse of depression based on the Montgomery-Åsberg Depression Rating Scale (MADRS), compared to the placebo plus standard of care group. Patients in the treatment arm also had their risk of relapse cut in half, suggesting the combination treatment may be effective in addressing depression.
“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 two,” said Dr. Maurizio Fava, 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.”
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The second long-term study conducted by Janssen looked at the safety of continual use of esketamine nasal spray for up to one year. The investigators found that the most common adverse events included metallic taste, vertigo and dissociation, however these were often resolved after one day of taking the medication.
“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 Dr. Mathai Mammen, 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.”
As a low-dose version of the veterinary medicine drug ketamine, esketamine represents a new approach to treating major depressive disorder. The drug targets the glutamate receptors in the brain which may have a positive effect on the synaptic connections between neurons.
It’s estimated that almost 300 million individuals globally suffer from major depressive disorder, which affects a person’s quality of life and ability to function. According to Janssen, up to one-third of patients diagnosed with major depressive disorder do not respond to treatment with currently-available antidepressants, making the clinical development of esketamine potentially important in meeting this unmet medical need.
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