NRx Pharmaceuticals has submitted a 70,000‑patient real‑world evidence dataset to the U.S. Food and Drug Administration to support accelerated approval of its preservative‑free intravenous ketamine formulation, NRX‑100, which is intended to treat suicidal ideation in depression and bipolar depression.
The dataset, compiled by Osmind, covers more than 70,000 U.S. patients who received either intravenous ketamine or nasal S‑ketamine, totaling nearly one million treatment sessions. It includes detailed vitals monitoring and assessments of bladder symptoms and sedation, providing a regulatory‑grade evidence base that the FDA can evaluate for safety and efficacy.
The submission follows the FDA’s September 2025 policy update that allows de‑identified real‑world evidence to be used in accelerated approval applications, and builds on NRX‑100’s existing Fast Track designation. By leveraging this policy change, NRx seeks to shorten the review timeline and bring a therapy to a population that currently has only electroconvulsive therapy as an FDA‑approved option.
NRx’s financial position remains tight, with a reported net loss of $28.9 million for the nine months ended September 30 2025 and a cash balance of $7.2 million. The company’s ability to secure accelerated approval is therefore critical, as it would unlock revenue streams that could support future capital needs and reduce reliance on additional fundraising.
CEO Jonathan Javitt emphasized the urgency of the unmet need, noting that "an American commits suicide every 11 minutes and ketamine has become widely used off‑label as a drug that has been seen to reduce suicidal ideation in clinical trials." He added that the partnership with Osmind "provides a robust data set that strengthens NRX‑100’s case for approval."
The RWE submission positions NRx to potentially bring a first‑in‑class, preservative‑free ketamine therapy to market, which could transform treatment options for suicidal depression and create a new revenue stream for the company. Success would also improve investor confidence in the company’s ability to navigate regulatory hurdles and manage its limited financial resources.
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