The Company continues to work with the U.S. Food and Drug Administration (FDA) during its review of its New Drug Application (NDA) for roluperidone for the treatment of negative symptoms of schizophrenia, in advance of the February 26, 2024 PDUFA date.
Niavana that’s one of the best news you could come with. Until this day no meds has been approved for the negatives.
It’s good news. I think that if approved, roluperidone will be the first drug for the negative symptoms of schizophrenia.
Are the trials showing this drug to be clinically significant for negative symptoms?
This is what I found about it.
‘‘Roluperidone, a 5-HT2A and sigma-2 receptor antagonist, was successful in a phase 2 trial for negative symptoms. The subsequent phase 3 trial was suggestive of efficacy, but statistical significance was lost vs. placebo in the intention-to-treat analysis. A possible complication of this drug is that it has been tested only as monotherapy, with no documentation that it is effective on total and positive symptoms.’’
However. This information is from July. Apparently they did more clinical trials and sent an NDA again.
I found this.
‘‘Roluperidone also failed in a Phase 3 trial in 2020, but subsequently showed evidence that it could target the negative symptoms of schizophrenia, such as apathy and social withdrawal, which remain resistant to treatment with current medications.
The drug was submitted to the FDA and although the regulator initially refused to accept the marketing application, a review has since begun with a decision expected on February 26 of next year.’’
We must wait until February 26.