J&J’s predicted blockbuster depression posts P2 data
pharmafile | January 3, 2018 | News story | Research and Development | Johnson & Johnson, biotech, depression, drugs, pharma, pharmaceutical
Johnson & Johnson has revealed Phase 2 data for its treatment for depression, esketamine, and the results are positive. The drug is an altered form of ketamine, more commonly known as a party drug, but the chemical is now being widely studied for its therapeutic potential within mental health.
Esketamine is delivered in an intranasal formulation, alongside standard oral antidepressants. J&J has big hopes for the treatment, predicting that it will become a blockbuster treatment should it see approval.
The FDA clearly deems the treatment to have potential, handing two breakthrough tags in major depressive disorder with imminent risk of suicide and for treatment-resistant depression.
The data from J&J’s latest study may well back up the hope for the treatment, as it managed to show not just efficacy but a rapid-onset of action and long-term duration.
Patients were separated into three different dose group (28 mg, 56 mg and 84 mg), which were delivered twice weekly for up to nine weeks. Response to treatments were measured on the Montgomery-Asberg Depression Rating Scale (MADRS), with results showing a reduction on the score relative to dose strength – 28mg saw a reduction of 4.2, 56mg by 6.3 and 84mg by 9.0 compared to placebo.
The effects of the treatment were observed as rapidly as two hours after treatment and persisted over the eight-week follow up period without requiring additional doses. There were also fewer patients who remitted on the treatment, 12.5%, 27.3% and 40.0% relative to dose strengths previously mentioned, compared to 10% in the placebo group.
“About one third of patients with major depressive disorder do not respond to current treatment options,” said Husseini K. Manji, Global Head, Neuroscience Therapeutic Area, Janssen. “The results of this study reinforce the potential of esketamine as a treatment for patients with treatment-resistant depression and support further clinical research, providing hope for people in need. If approved by the FDA, esketamine would be one of the first new approaches to treat refractory major depressive disorder available to patients in the last 50 years.”
The common side-effects of treatment were dizziness, headache and perceptual changes/dissociative symptoms.
The treatment is currently undergoing Phase 3 clinical trials for treatment-resistant depression and for patients with major depressive disorder who are imminent risk for suicide. With such a paucity of treatment options beyond standard oral antidepressants, to the extent that ketamine is now often used off-label for patients who are resistant to current treatments.
Ben Hargreaves
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