Minerva Neurosciences Inc (NASDAQ: NERV) has announced the submission of a New Drug Application to the US FDA for roluperidone in treating negative schizophrenia symptoms in patients. The company is currently developing roluperidone as an effective treatment for managing negative schizophrenia symptoms, which is a massive unmet medical need for many patients.
Roluperidone could offer an alternative treatment for schizophrenia symptoms
Roluperidone, according to the company, could be a novel therapeutic treatment option for people with negative schizophrenia symptoms for which there aren’t any US-approved treatments at the moment. Antipsychotics can effectively treat symptoms of schizophrenia, but negative symptoms are frequently the main strain of the disease. In addition, they can negatively affect a patient’s overall quality of life due to limitations brought on by poor social and vocational functioning.
CEO and Chairman Remy Luthringer said, “We would like to express our sincere appreciation and thanks to all the patients, caregivers, investigators, and staff who participated in the roluperidone clinical studies. We have been in dialogue with the FDA following our Type C meeting in March 2022, and we look forward to working with the FDA as it evaluates the NDA.”
Two late-stage studies supported the NDA submission
Findings from two late-stage, controlled trials in individuals with moderate-to-severe negative schizophrenia symptoms and steady positive signs of schizophrenia supported the NDA proposal. The two studies were intended to provide the majority of data supporting the efficacy of roluperidone in treating schizophrenia’s negative symptoms.
The plan depended on the studies being of the similar overall design of the study. They were both randomized, multicenter, double-blind, multi-national, parallel-group, placebo-controlled studies in which participants received either 64 mg or 32 mg roluperidone doses. For both studies, individuals who were receiving antipsychotic medications had to stop taking them and wait two days before starting the designated study treatment.
On April 7, 2022, the company announced the receipt of official Type C meeting minutes for the meeting held with the FDA on March 2, 2022, in which roluperidone development for treating negative schizophrenia symptoms was discussed.