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.
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.