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With data-lock, as forecast in last week's earnings call, the complete data set passed on for statistical analysis; top-line data release expected in
With positive data from this study and FDA comment, NRx becomes eligible to receive the balance of its first milestone (an additional
NRX-101 has been awarded Breakthrough Therapy Designation, Fast Track Designation, a Biomarker Letter of Support, and a Special Protocol Agreement by the FDA for treatment of Suicidal Treatment Resistant Bipolar Depression. It is the only oral medication to have demonstrated both reduced symptoms of depression and reduced suicidal ideation in patients with bipolar depression, a lethal disease that claims the lives of one in five who live with it.
The previous STABIL-B trial, (Ref. STABIL-B) resulted in the award of Breakthrough Therapy Designation for the use of NRX-101 following ketamine in hospitalized patients with Severe Bipolar Depression and Acute Suicidal Ideation and NRx was cleared by FDA to conduct a phase III trial in this regard under the Special Protocol Agreement. FDA then suggested that the Company explore whether NRX-101 might be applicable to the much larger population of patients with subacute suicidality who are cared for in the outpatient setting on a chronic basis. The purpose of this trial was to determine whether a signal could be detected that would support a much broader indication for NRX-101. Successful data in this regard would expand the potential market for NRX-101 from several hundred thousand patients per year to several million patients per year.
'Patients with active suicidal ideation have been excluded from the clinical trials of all previously known oral antidepressants. This trial of NRX-101 is the first under an FDA Investigational New Drug application to attempt to develop an oral therapy that offers patients with suicidal bipolar depression an alternative to electroconvulsive therapy, which is currently the only FDA-approved therapy for suicidal depression,' said Dr.
The Phase 2b/3 trial (www.clinicaltrials.gov NCT 03395392) is a randomized, prospective, multicenter, double-blind study comparing NRX-101 to lurasidone over six weeks. The Principal Investigator is Prof.
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NRx has recently announced plans to submit a New Drug Application for HTX-100 (IV ketamine), through Hope Therapeutics, in the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the
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