Funding support for the study came, in part, from Novo Nordisk
While one study did show statistical significance, the FDA said in a Complete Response Letter that it was insufficient on its own [to provide] substantial evidence of effectiveness. The FDA also noted that the NDA submission lacked data on concomitant antipsychotic administration, did not include data that established that the change in negative symptoms was clinically meaningful and that the submitted safety database had an inadequate number of subjects exposed to roluperidone at the proposed dose of 64 mg for at least 12 months
Quinidine, disopyramide, and procainamide are used in the management of supraventricular tachyarrhythmias, recurrent atrial fibrillation, ventricular tachycardia, ventricular fibrillation, Brugada syndrome, and Short QT Syndrome (SQTS) (4)
doi:10.1001/jamapediatrics.2021.1329 Lim R, et al
Prescriptions must be issued within the following timeframe: a
This finding is critical