Johnson & Johnson said its esketamine nasal spray delayed relapse among depression patients and was found to be tolerable in two phase 3 studies.
The first study enrolled 705 adult patients with treatment-resistant depression who had been treated with esketamine nasal spray plus an oral antidepressant for 16 weeks. Two distinct group of patients were involved in the study — those who showed remission, or complete relief of symptoms and those who were responding to the treatment but were not in remission.
Treatment-resistant depression was defined as when patients had not responded to two or more currently available antidepressants in the current episode of depression.
Johnson & Johnson said the first study met its main goal with the combination of esketamine and an oral antidepressant showing a statistically significant delay in relapse among patients in stable remission compared to those receiving an oral antidepressant plus placebo.
Results showed that patients treated with esketamine plus an oral antidepressant had a 51% lower risk of relapse than those in the oral antidepressant plus placebo group. The study also met its secondary goal as the esketamine combination demonstrated a statistical superiority over placebo group in delaying relapse among patients who showed a stable response to the therapy but did not reach remission.
The combination of esketamine and the oral antidepressant was found to be safe and tolerable with repeated, intermittent long-term dosing. The company stated that out of the 41 serious adverse events reported in the study, seven events could have been related to esketamine.
Johnson & Johnson also reported results from a long-term safety study involving 802 adult patients where, unlike the first double-blind study, both the researchers and participants knew about the treatment being received.
The study showed that treatment with esketamine nasal spray plus an oral antidepressant for up to one year was tolerable with no new safety signals after repeated long-term dosing. Of the 68 serious treatment-related adverse events, five serious adverse events were found to be esketamine nasal spray-related.
Two patients died during the study with no connection found with the use of esketamine nasal spray or oral antidepressant.
In terms of efficacy, the study indicated that esketamine combination appeared to be associated with sustained improvement in depressive symptoms.
Johnson & Johnson has conducted five phase 3 studies of esketamine nasal spray in patients with treatment-resistant depression, including three short-term studies, one withdrawal maintenance of effect study and one open-label long-term safety study.
The results from two short-term studies in May demonstrated that esketamine showed a statistically significant reduction of depressive symptoms in adults and a clinically meaningful effect among elderly patients aged 65 and older.
Esketamine is a glutamate receptor modulator, which is thought to help in restoring communication between brain cells in patients with major depressive disorder. The company said, citing data from the World Health Organization, that major depressive disorder affects nearly 300 million people globally.
