FDA Grants Fast Track Designation to QRX003, Supports NRX-100 NDA
The FDA granted Fast Track Designation to Quoin's QRX003 for Netherton Syndrome and supported NRx's NRX-100 NDA path under Fast Track for treatment-resistant depression, addressing serious unmet needs.
The U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to QRX003 lotion (4%) for the treatment of Netherton Syndrome, a rare and severe genetic skin disorder with no approved therapies. Separately, the agency indicated that existing clinical and real-world data could support a New Drug Application (NDA) for NRX-100 (preservative-free ketamine) under its Fast Track Designation for treatment-resistant depression with suicidality.
Quoin Pharmaceuticals Ltd. announced the Fast Track Designation for QRX003, which is currently being evaluated in two late-stage whole-body clinical trials. The designation facilitates development and expedites regulatory review of therapies addressing serious conditions with significant unmet medical need. Fast Track status enables more frequent communication with the FDA, eligibility for rolling review of regulatory submissions, and potential qualification for Accelerated Approval and Priority Review, if relevant criteria are met.
"We believe that the FDA's decision to grant Fast Track Designation to QRX003 reflects the urgent unmet need faced by patients and families living with Netherton Syndrome," said the CEO and Co-Founder of Quoin Pharmaceuticals. QRX003 previously received Orphan Drug Designation from both the FDA and the European Medicines Agency, as well as Pediatric Rare Disease Designation. Netherton Syndrome is caused by mutations in the SPINK5 gene, leading to severe skin barrier dysfunction, chronic inflammation, and a heightened risk of infections.
For NRx Pharmaceuticals, the company completed a Type C meeting with the FDA regarding NRX-100. The agency indicated that existing clinical trial data plus Real-World Evidence from over 65,000 patients could support an NDA under Fast Track Designation, with no additional nonclinical or bridging studies required. NRx plans to seek a broader indication in treatment-resistant depression with suicidality and will finalize its Real-World Evidence analysis protocol in the coming weeks. The meeting included input from Osmind, Inc., Psychiatry Products, and leadership of FDA's Center for Drug Evaluation and Research (CDER).
NRx Pharmaceuticals' shares closed at $1.84, up 3.66% following the announcement.