Will J&J TRANSFORM Esketamine Into A Viable Depression Treatment?
In early 2018 Johnson & Johnson is expecting to announce the first data from its long-awaited pivotal clinical trial program for esketamine in treatment-resistant depression; a successful result will open a lucrative commercial opportunity for J&J and give the wider depression market a new direction for growth.
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J&J released data from the first two Phase III trials testing esketamine in patients with treatment-resistant depression, but only one study met the primary efficacy endpoint.
CEO Jeff Jonas said the rapid and durable response to just two weeks of treatment with SAGE-217 coupled with the oral drug's safety in a short-term Phase II study support first-line use of the novel therapy, but plans for a Phase III depression program are not yet known.
Alkermes’s announcement of positive findings in the FORWARD-5 trial of its treatment-resistant depression drug ALKS 5461 came as a surprise, given the past two Phase III trials disappointed, but if it can gain approval, the buprenorphine/samidorphan product could meet an unmet need.