NeuroRx expects to initiate a Phase 2b/3 clinical trial of NRX-101 (Cyclurad™) preceded by a single infusion of ketamine for the treatment of Acute Suicidal Ideation/Behavior (ASIB) in Bipolar Depression in early 2017.
Because ketamine is already FDA approved as an anesthetic, and NRX-101 combines two FDA-approved drugs, the company plans to pursue a 505(b)(2) regulatory path, which may offer a significantly expedited approval process. In addition, the company intends to pursue Orphan Drug and Fast Track designations for NRX-101 in the treatment of ASIB in Bipolar Depression.
Based on these strategies, the company believes commercialization may be possible as early as 2018.
NeuroRx believes that the 505(b)(2)
regulatory path may
offer a significantly expedited approval
process for NRX-101 (Cyclurad™).