NDA filing for roluperidone for the treatment of negative symptoms in schizophrenia

The decision to file the NDA follows the Company’s request for formal dispute resolution and appeal of FDA’s October 2022 refuse to file letter. The issues cited in the refuse-to-file decision included those discussed at the type C meeting in April 2022. In granting the appeal, the FDA deciding official agreed with the Company that the issues cited in the refuse-to-file decision should be considered during FDA’s review of the NDA.

Negative symptoms are a major source of disability in people with schizophrenia and there have been no approved treatments to date. An approved treatment for negative symptoms could revolutionize the treatment of schizophrenia and would certainly have a major impact on the quality of life of the millions of people affected with this disease,” said Dr. Philip Harvey, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences and Director of the Division of Psychology at the University of Miami Miller School of Medicine..