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NeuroRx Drug for Suicidal Bipolar Depression Receives Notification of Patent Allowance

Company to attend upcoming JP Morgan Healthcare Conference

WILMINGTON, Del., Jan. 8, 2020 /PRNewswire/ — NeuroRx, Inc announced that it has received a notice of patent allowance covering the Composition of Matter for its drug NRX-101, which targets suicidal bipolar depression, an unmet medical need that results in the death of more than 25,000 Americans each year.

The allowance is based on US Patent Application 15/987,932 entitled: Composition and Method for Treatment of Depression and Psychosis in Humans. The inventor, Prof. Daniel Javitt, Ph.D., M.D., is co-founder of NeuroRx and was among the first to report the role of the NMDA receptor in psychiatric disease.

NRX-101, an NMDA-targeted antidepressant, is a fixed-dose combination of D-cycloserine and lurasidone and was awarded Fast Track and Breakthrough Therapy Designation by the US FDA.  The drug is currently undergoing phase 3 clinical trials under an FDA Special Protocol Agreement ( Identifier: NCT03396068).

NeuroRx’s Chairman and CEO, Dr. Jonathan Javitt, and Chief Commercial Officer, Mr. Robert Besthof, will be attending the upcoming JP Morgan Healthcare Conference in San Francisco, CA.

About NeuroRx, Inc.:

NeuroRx draws upon 30 years of basic science and clinical expertise in the role of N-methyl-D- aspartate (NMDA), a receptor that regulates human thought processes, particularly depression and suicidality. The company is privately funded and led by former senior executives of Johnson & Johnson, BMS, Eli Lilly, Pfizer, and Sunovion. NeuroRx’s Board of Directors and Advisors includes Hon. Sherry Glied, former Assistant Secretary, U.S. Dept. of Health and Human Services; Mr. Chaim Hurvitz, former President of the Teva International Group, Lt. Gen. HR McMaster, the 23rd National Security Advisor, Wayne Pines, former Associate Commissioner of the U.S. Food and Drug Administration, Judge Abraham Sofaer, and Daniel Troy, former Chief Counsel, U.S. Food and Drug Administration.

About NRX-101

NRX-101 is designed to address suicidal bipolar depression for which there is no currently approved drug and for which the only FDA-approved treatment remains electroconvulsive therapy (ECT). NRX-101 is a patented, oral, fixed-dose combination of D-cycloserine, an N- methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, which has D2/5-HT2a receptor antagonist activity. The combination has shown statistically-significant reduction in both depression and suicidal ideation in phase 2 studies and was awarded FDA Breakthrough Therapy Designation and Fast Track Designation.  A pivotal phase 3 study is ongoing under an FDA Special Protocol Agreement that targets patients with Severe Bipolar Depression and Acute Suicidal Ideation.

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