- The FDA designation expands the drug’s potential patient pool tenfold, to an estimated 13 million Americans who consider suicide annually.
- Clinical trials demonstrated rapid and statistically significant reductions in suicidal ideation with IV ketamine versus placebo and comparators.
- Fast Track status makes NRX-100 eligible for Accelerated Approval and the Commissioner’s National Priority Voucher program.
- NRx is preparing an expanded access policy and seeking meetings with FDA leadership to align on data submission.
- The U.S. suicidal depression market is estimated at more than $3 billion annually.
NRx Pharmaceuticals (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, announced that the U.S. Food and Drug Administration (“FDA”) has granted Fast Track designation to its intravenous ketamine formulation, NRX-100, for the treatment of suicidal ideation in patients with depression, including bipolar depression (https://ibn.fm/LYPf7).
The new designation expands NRX-100’s potential patient population by tenfold compared to the FDA’s 2017 designation, which was limited to use in combination with NRX-101 for suicidal bipolar depression. This expansion also reflects the FDA’s determination that NRX-100 has the potential to address an “unmet medical need.” That determination is a prerequisite for eligibility under the Commissioner’s National Priority Voucher (“CNPV”) program, which could shorten the review timeline.
The broader indication covers an estimated 13 million Americans who experience suicidal ideation annually, with 1.5 million attempts and one death every 11 minutes, according to Centers for Disease Control data. Treatment options remain limited, particularly for patients experiencing acute suicidal ideation (https://ibn.fm/xrF6G).
Several controlled trials informed the FDA’s decision. A Columbia University study licensed by NRx showed that IV ketamine achieved a 55% response rate, defined as a 50% reduction in suicidality, compared to 30% in patients receiving an active comparator. The results were statistically significant (P<.02).
Similarly, a French government-sponsored trial found that 63% of patients achieved full remission from suicidal ideation within three days of IV ketamine administration, compared to 31% for placebo (P<.001).
These outcomes have not been replicated with intranasal ketamine, which is sometimes used off-label for depression.
Fast Track designation enables closer interaction with the FDA, rolling review of new drug application materials, and potential eligibility for accelerated approval. NRx Pharmaceuticals has applied for the CNPV program and intends to meet with FDA leadership to finalize data submission plans.
The company also announced it will publish an expanded access policy within two weeks, a step that could allow certain patients earlier access to the drug while trials continue.
NRx Pharmaceuticals estimates that NRX-100 could target a U.S. suicidal depression market valued at more than $3 billion annually. Importantly, while ketamine is widely used off-label for mood disorders, FDA approval would make reimbursement by most insurers more likely, broadening patient access beyond those who can pay out of pocket.
NRX-100 is also notable as the first preservative-free IV ketamine formulation submitted to the FDA. Existing products often include benzethonium chloride (“BZT”), a preservative not recognized as safe by regulators. NRx’s formulation demonstrated long-term stability and sterility, with an anticipated three-year room temperature shelf life.
The company recently filed a Citizen Petition requesting that BZT-containing products be removed from the market and has initiated U.S.-based high-volume manufacturing for its preservative-free version.
Dr. Jonathan Javitt, Chairman and CEO of NRx, described the Fast Track designation as “a significant step forward” in the company’s mission to address the suicide crisis among both civilian and military populations. “Large-scale government-supported trials have demonstrated a robust and statistically significant reduction in suicidal ideation and depression with administration of ketamine,” Dr. Javitt added. “This drug was also proven to be non-inferior to electroshock therapy in treating depression without the negative side effects of ECT. We look forward to working closely with the FDA in our quest to Bring Hope to Life.”
For more information, visit the company’s website at www.NRxPharma.com.
NOTE TO INVESTORS: The latest news and updates relating to NRXP are available in the company’s newsroom at https://ibn.fm/NRXP
