On Track To Approval, Alkermes Hopes ALKS-5461 Can Change Future Of Depression Therapy
The novel opioid-system antidepressant is being positioned for adjunctive therapy on top of SSRIs, but Alkermes is eyeing other indications, and better ways to stratify and treat depressed patients.
You may also be interested in...
Janssen filed an NDA for esketamine nasal spray for treatment-resistant depression with FDA, which could grant a six-month priority review.
Proposed list of topics for review in 2019 by the Institute for Clinical and Economic Review includes a total of 15 drugs but that could change as the year goes on.
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.