WILMINGTON, DE — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that it will make its investigational therapy NRX-100, a preservative-free formulation of ketamine, available through the U.S. Food and Drug Administration’s expanded access program. The move follows the FDA’s decision to grant Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression.
Addressing an Urgent Public Health Need
Suicidal ideation remains a widespread crisis, with the Centers for Disease Control and Prevention estimating that 13 million U.S. adults seriously consider suicide each year. An American dies from suicide roughly every 11 minutes. The FDA granted Fast Track designation after determining that NRX-100 shows potential to meet an unmet medical need based on preliminary data.
Jonathan C. Javitt, M.D., chairman and CEO of NRx Pharmaceuticals, said the company recognizes the urgency of expanding access. “We at NRx recognize the urgent need to make NRX-100 available to patients with suicidal depression for whom approved therapies are not tolerated or effective. We look forward to participating in FDA’s expanded access program and to serving patients in need as we endeavor to Bring Hope to Life,” he said.
Expanded Access Pathway
The program will allow physicians to request NRX-100 for patients with life-threatening depression who have not responded to existing treatments. Several conditions must be met before access is granted, including:
- Confirmation that the patient has a serious or life-threatening condition unresponsive to approved options.
- Sufficient clinical data to establish a safe dosage and treatment schedule.
- A favorable benefit-risk assessment by both the physician and NRx.
- Assurance that expanded access will not delay clinical trials or regulatory review.
- Adequate supply of the drug.
Ongoing Clinical Development
NRX-100 remains under active clinical investigation, with ongoing studies designed to evaluate safety, dosing, and efficacy. By providing access under FDA oversight, the company aims to help patients in critical need while continuing to collect data necessary for broader approval and commercialization.
With suicide rates climbing and treatment-resistant depression remaining a persistent challenge, the expanded access program provides a pathway for patients to receive an investigational therapy that could address one of the nation’s most pressing mental health crises.
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