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New to The ⁤Street‌ Highlights FDA Approval for NRx⁣ Pharmaceuticals’ Ketamine Initiative

NEW YORK, NY – [Date of Release] – ⁢ New to The Street, a⁤ leading financial news and corporate⁤ profiling ⁢television brand, is⁢ spotlighting a⁢ significant milestone achieved by its ⁣client, NRx pharmaceuticals, Inc. (NASDAQ: NRXP). The FDA has approved NRx’s Suitability Petition, paving the⁤ way for the​ company to​ re-file an Abbreviated New Drug Request ‌(ANDA) for its proposed preservative-free formulation of ketamine, KETAFREE™.

This approval represents ​a crucial step forward for⁣ NRx Pharmaceuticals, which is developing KETAFREE™⁢ for a market currently estimated at $750 million. Beyond this commercial opportunity, NRx is also pursuing approval of its‌ non-generic ketamine formulation, NRX-100, as a novel treatment for ⁤suicidal depression and PTSD through a New Drug Application (NDA).the company has also applied for the Commissioner’s National Priority Voucher‌ Program for NRX-100.

“NRx Pharmaceuticals is breaking new ground in mental health and patient safety​ with its preservative-free ketamine initiative,” stated vince Caruso, ‌Co-Founder and CEO of New to the⁣ street.”This FDA approval of their Suitability Petition is ​a pivotal ⁣milestone, and we are proud to showcase their journey across our national broadcast platforms. their work exemplifies the type of innovation⁣ and impact that resonates ‌with investors, business leaders, and patients alike.”

nrx Pharmaceuticals’ Chairman‍ and CEO, Jonathan C.‍ Javitt, MD,‌ MPH, expressed appreciation for the ​FDA’s responsiveness and stated the company looks forward to bringing the ⁣preservative-free ⁤ketamine presentation to the US market “at the earliest​ possible moment.”⁢ He⁤ also noted NRx’s recent participation in a listening session hosted ⁣by the FDA ⁢Commissioner ⁤for biotechnology CEOs.

NRx‍ Pharmaceuticals is focused on developing therapeutics for central nervous system ⁣disorders, leveraging its NMDA‍ platform. The company’s NRX-100 has⁤ received Fast ⁤Track ⁤designation for suicidal ideation in depression, including bipolar depression, while ⁤NRX-101 (oral D-cycloserine/lurasidone) has been awarded Breakthrough Therapy ⁢Designation ⁢for the treatment of suicidal bipolar depression.

New to The Street, broadcasting weekly on Fox Business and Bloomberg, delivers its⁣ signature “Opportunities To Consider™” segments to ⁢a broad ​audience of investors and business leaders. With a substantial online presence including over 3.5 million YouTube ‍subscribers and prominent Times Square billboards, the platform ‌provides significant exposure for companies like NRx Pharmaceuticals.

Source: New To The Street – [link to original press release: https://www.accessnewswire.com/newsroom/en/publishing-and-media/new-to-the-streets-prestigious-client-nrx-pharmaceuticals-inc.-nasdaq-nrxp-rec-1077512]**