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FDA removes hold on phase III trial of EVP 6124 (encenicline) in cognitive impairment in schizophrenia- Forum Pharma

Read time: 1 mins
Last updated:13th Nov 2015
Published:13th Nov 2015
Source: Pharmawand

The FDA has removed a partial clinical hold on the Phase III study of EVP 6124 (encenicline), from Forum Pharma, for cognitive impairment in schizophrenia (CIS). This partial hold applied to a 26 week Phase III extension study. The two global Phase III efficacy and safety trials evaluating the use of encenicline to treat CIS are nearing completion, with top-line results anticipated in the first half of 2016.

Phase III trials of encenicline to treat Alzheimer’s disease remain on clinical hold while Forum Pharma gathers and analyzes trial data, which will be discussed with the FDA during 2016, to potentially lift the hold and define a possible path forward for encenicline in Alzheimer’s disease.

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