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]**
