NRx Pharmaceuticals, Inc. (NRXP) reported a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in clinical trial in patients with suicidal bipolar depression. Therefore, the company believes that demonstration of reduced akathisia in the setting of comparable antidepressant efficacy constitutes a basis for Accelerated FDA Approval of NRX-101.
NRx Pharmaceuticals said it plans to seek accelerated approval of NRX-101 for use in patients with bipolar depression at risk of akathisia while continuing to broaden the indication to all patients with bipolar depression and perhaps schizophrenia.
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