J&J’s ketamine-based antidepressant showed mixed success at Phase 3
pharmafile | May 8, 2018 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | J&J, JJ, Johnson & Johnson, Ketamine, antidepressant, depression, esketamine, pharma
Johnson & Johnson has revealed new data on its new depression drug esketamine, its chemically ‘left-handed’ version of the controlled anaesthetic often used recreationally, painting a mixed picture of its efficacy.
J&J’s drug, which is delivered via a nasal spray, was tested in treatment-resistant depression, defined as unaffected by two or more currently available antidepressant medications of adequate dose and duration. When used in combination with a newly initiated oral antidepressant, esketamine produced a “statistically significant, clinically meaningful, rapid reduction of depressive symptoms” compared to placebo nasal spray plus a newly initiated oral antidepressant.
However, in a second study of the drug in patients over 65 years of age, the drug missed statistical significance for its primary endpoint, but the manufacturer noted that it demonstrated “clinically meaningful effects” in this group compared to placebo.
“With about 30% of patients with major depression failing to respond to currently available antidepressants3, treatment-resistant depression represents a major public health need,” said Dr Husseini K Manji, Global Head, Neuroscience Therapeutic Area at Janssen. “The positive Phase 3 results for esketamine nasal spray in adults with treatment-resistant depression are exciting, particularly as they mark the first time an antidepressant has achieved superiority versus an active comparator in any clinical trial for major depressive disorder. What makes this significant is that the response was rapid and this milestone was achieved in patients deemed to be treatment-resistant. We are also pleased with the clinically meaningful outcomes for esketamine nasal spray in elderly patients, a population that often has greater disability and lower response rates.”
Dr Mathai Mammen, Global Head at Janssen Research & Development, added: “There’s a critical need for new, rapidly acting and effective treatment options for people with major depressive disorder who do not respond to existing therapies. Janssen is fully committed to exploring the newest science in the area of mood disorders and bringing these discoveries to patients in need.”
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