RADNOR, PA — NRx Pharmaceuticals (Nasdaq: NRXP) recently highlighted a compelling advantage in safety for its drug NRX-101, in comparison to the standard treatments offered in its latest clinical trial. The trial focused on patients battling suicidal bipolar depression, and NRx has suggested that this could lead to a quick approval from FDA due to a noticeable decline in akathisia, a common side effect linked with depression medications.
The company has outlined these crucial discoveries, backed by regression analysis, in line with a Special Protocol Agreement with FDA. Coupled with prior trials, this showcases a strong foundation for a swift drug approval of NRX-101. The FDA approval would be based on the improved safety concerning akathisia and suicidality while maintaining similar antidepressant efficacy.
The clinical trial monitored patients using the Barnes Akathisia Rating Scale (BARS). At the onset, all participants had matching scores, but the group treated with NRX-101 experienced a decrease, in comparison to an increase in the group treated with lurasidone, a common drug for bipolar disorder. The relative mean difference between groups was 76%, an impressive result that continued throughout the trial’s duration.
Beyond the relative safety aspect, the drug demonstrated comparable antidepressant effect when compared to lurasidone amongst the trial participants, who suffered from suicidal bipolar depression. Even though improved antidepressant efficacy isn’t required for accelerated drug approval, a non-significant sustained decrease in suicidality by 33% favoring NRX-101 was observed.
Citing this safety finding, NRx intends to request an Accelerated Approval of NRX-101 for bipolar depression patients prone to akathisia, while also working to develop evidence supporting broader implications in treating depression and schizophrenia. Should further large scale trials validate these results, physicians and patients might show a preference for antidepressant and antipsychotic drugs with lessened risks of akathisia, a common and often debilitating side effect.
NRx’s Chairman and Chief Scientist, Dr. Jonathan Javitt, stated, “More than 7 million Americans suffer from bipolar depression with a potential market opportunity in excess of $20 billion. No prior drug to treat bipolar depression has demonstrated superiority on side effects most closely linked to suicide.” He further added that the company plans to seek sped-up FDA approval for patients at risk for akathisia.
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