© 2016 NeuroRx, Inc.

*These drugs are investigational and not approved by the US FDA

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Development Strategy

NeuroRx initiated a Phase 2b/3 clinical trial of NRX-100/NRX-101 for the treatment of Bipolar Depression in patients with Acute Suicidal Ideation/Behavior (ASIB) in late 2017.

 

Because NRX-100 (ketamine) is already FDA approved as an anesthetic, and NRX-101 combines two FDA-approved drugs, the company is pursuing a 505(b)(2) regulatory path, which may offer a significantly expedited development process. In addition, the company is exploring an Orphan Drug Designation for NRX-100/NRX-101 in the treatment of Bipolar Depression in patients with ASIB.

 

In Sept. 2017, NeuroRx was granted Fast Track Status by the FDA for the sequential NRX-100/NRX-101 therapy targeting Bipolar Depression associated with ASIB.

 

Based on these strategies, the company believes commercialization may be possible as early as 2019/2020.

 

 

 

 

 

NeuroRx believes that the 505(b)(2)

regulatory path may

offer a significantly expedited development

process for NRX-100/NRX-101.