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FAQ: NRx Pharmaceuticals' Real-World Evidence Licensing for NRX-100 FDA Approval
TL;DR
NRx Pharmaceuticals gains a competitive edge by licensing real-world evidence from 70,000 patients to accelerate FDA approval of NRX-100 for suicidal depression treatment.
NRx Pharmaceuticals will submit extensive real-world data from Osmind, including nearly one million treatment sessions, to the FDA following a 2025 policy update for regulatory approval.
NRX-100's potential approval could expand supervised treatment access for suicidal depression, addressing an unmet medical need and improving patient outcomes through regulated ketamine therapy.
NRx Pharmaceuticals leverages real-world evidence from 70,000 ketamine-treated patients to pioneer the first FDA-approved drug for suicidal ideation in depression.
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NRx Pharmaceuticals has licensed regulatory-grade real-world evidence from more than 70,000 U.S. patients treated with intravenous ketamine or nasal S-ketamine for depression and suicidal ideation to support its application for Accelerated Approval of NRX-100 under Fast Track Designation.
NRX-100 is a preservative-free intravenous ketamine being developed for the treatment of suicidal ideation in depression, including bipolar depression, an area where no drug therapy is currently approved.
The dataset includes nearly one million treatment sessions and extensive longitudinal safety and effectiveness data from actual patient treatments, which will support NRx's application following a 2025 policy update allowing de-identified real-world evidence for FDA submissions.
The dataset was provided by Osmind and includes evidence from more than 70,000 U.S. patients treated with intravenous ketamine or nasal S-ketamine for depression and suicidal ideation.
NRX-100 has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression, and NRx has initiated a New Drug Application filing with an application for the Commissioner's National Priority Voucher Program.
NRx is developing NRX-101 (oral D-cycloserine/lurasidone), which has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression, and focuses on NMDA platform therapeutics for central nervous system disorders including chronic pain and PTSD.
The dataset will be submitted to the U.S. Food and Drug Administration following a 2025 policy update that allows de-identified real-world evidence to be used in regulatory applications.
While ketamine is used off-label for depression and suicidal ideation, NRX-100's regulatory approval would expand access to supervised treatment and provide an approved drug therapy for an area where none currently exists.
The latest news and updates relating to NRXP are available in the company's newsroom at https://ibn.fm/NRXP, and the full press release can be viewed at https://ibn.fm/ZUJbn.
By leveraging real-world evidence from existing ketamine treatments, NRx aims to accelerate approval of NRX-100 for a serious condition with no currently approved drug therapy, potentially providing a new treatment option for patients with suicidal ideation in depression.
Curated from InvestorBrandNetwork (IBN)
