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Thursday, December 8, 2022

NRx Pharma - Unmet Medical Needs and Life Saving Medicines

COVID-19 wreaked havoc on people’s health, causing a slew of respiratory problems. NRx Pharma is concentrating on the development of NRX-101. ZYESAMI (aviptadil), an intravenous and inhalation medication to treat respiratory failure in COVID-19, and NRX-101, oral medicine for treating Acute Suicidal Behavior/Ideation (ASIB) in bipolar disorder. NRX Pharmaceuticals, Inc. (previously Big Rock Partners Acquisition Corp.) is a clinical-stage pharmaceutical firm that focuses on patients. NRX-101 is a home-use oral, rapid-onset, and sustained medication that can extend ketamine’s anti-suicidal effectiveness while reducing the drug’s adverse effects. D-cycloserine (DCS), an N-methyl-D-aspartate (NMDA) receptor modulator, and lurasidone, a 5-HT2a receptor antagonist, are used by the company. Clinical trials for NRX-101 are now in Phase III. NRx develops cutting-edge, life-saving medications and provides hope to those suffering from life-threatening illnesses with no authorized disease-modifying therapies or solutions. In collaboration with top medical specialists, NRx uses its unique clinical and scientific experience to create well-known compounds with no approved treatments for medical illnesses. NRx envisions a society in which scientific progress allows previously incurable diseases to be treated. NRx Pharma is dedicated to offering unique treatments and helping individuals suffering from chronic illnesses.

NRx is working on drugs to treat COVID-19, which is both severe and critical. While many people may get a slight viral illness, tens of thousands will wind up in hospitals with COVID-19 and will be unable to breathe. In the ICU, all patients with Critical COVID-19 have Acute Respiratory Distress (ARDS), which causes them to struggle to breathe and puts them at danger of mortality. There are currently no licensed treatments for Critical COVID-19 patients suffering from respiratory failure, leaving doctors in need of new drugs to assist people suffering from the severe symptoms of COVID-19 in breathing better and healthier. NRx is dedicated to discovering innovative solutions to help COVID-19 patients with respiratory failure restore their health, leave the hospital, and return home sooner.

Bipolar disorder is a mental condition that causes a person’s mood, energy, and ability to think correctly to shift dramatically. Bipolar disorder causes highs and lows in mood, referred to as mania (highs) and depression (lows). These common, severe behavioral changes in people with bipolar illness are distinct from the mood swings that most people experience. Bipolar depression is a prevalent sign of this mental disorder, and in more than half of patients, suicidal ideation, or the desire to take one’s life, is present. Electroshock therapy, a technique performed under general anesthesia in which electric currents are sent into the brain, purposely producing a short seizure, is currently the only FDA-approved treatment for individuals with Bipolar Depression coupled with suicidal thoughts. In collaboration with Relief Therapeutics, AG, they have medicinal candidates in Phase 2 and Phase 3 studies for COVID-19-related Lung Injury and Acute Respiratory Distress (ARDS) and the first medicine in the development to treat Bipolar Depression in Patients with Acute Suicide.

NRx recently distributed ZYESAMI, manufactured at commercial scale, under Good Manufacturing Practices (GMP) for clinical studies and other potential applications allowed in future regulatory proceedings, without any clinical hold imposed by the FDA. NRx is eager to collaborate with the FDA on the chemical, manufacturing, and controls (CMC) evaluation necessary for any prospective medication approval. Until now, ZYESAMI was only available for clinical studies in handcrafted 300 dosage batches with a 62-day shelf life. The FDA has currently assessed a GMP manufacturing process with a batch size of 10,000 to 100,000 doses and a current shelf life of 150 days and found no reason to place a clinical hold on the product. “This represents the first time aviptadil has been manufactured in an FDA-inspected commercial GMP environment for intravenous and inhaled use and passed the regulatory review of manufacturing and CMC. With the help of our partners at Nephron Pharmaceuticals, we have validated the analytic techniques required to test the purity, potency, and stability of our medicine as required by the FDA and other regulators. We have advanced a generic ingredient (aviptadil) into a modern drug that meets GMP specifications and that can be manufactured at commercial scale, cost, and shelf life,” says Prof Jonathan Javitt, MD MPH Chairman and CEO, NRx Pharmaceuticals. NRx Pharma aspires to provide hope to people with unmet medical needs by developing life-saving medications.

“NRx is working on drugs to treat COVID-19, which is both severe and critical. While many people may get a slight viral illness, tens of thousands will wind up in hospitals with COVID-19 and will be unable to breathe.”

NRx Pharma
N

Prof Jonathan Javitt
Management 
MD MPH Chairman, and CEO
https://www.nrxpharma.com/

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