Free Republic

NeuroRx Announces ZYESAMI™ (aviptadil, RLF-100) Met the Primary Endpoint of Its Phase 2b/3 Clinical Trial and Also Demonstrated a Meaningful Benefit in Survival from Critical COVID-19 RADNOR, Pa., March 29, 2021 /PRNewswire/ -- NeuroRx, Inc. today reports 60-day results of the Phase 2b/3 trial of intravenously-administered ZYESAMI™ (aviptadil acetate) for the treatment of respiratory failure in critically-ill patients with COVID-19, which is being developed in collaboration with Relief Therapeutics Holding AG (SIX:RLF,OTCQB:RLFTF). Across all patients and sites, ZYESAMI™ met the primary endpoint for successful recovery from respiratory failure at days 28 (P = .014) and 60 (P = .013) and...

New Drug Promises “Rapid Recovery From Respiratory Failure”“Overall, 81% of RLF-100™-treated patients survived beyond 60 days, compared to 17% of control patients.” Oct 13, 2020 GENEVA and RADNOR, Pa., Oct. 13, 2020 /PRNewswire/ – RELIEF THERAPEUTICS Holding AG and NeuroRx, Inc., today announced topline results from 45 patients assessed in an open-label prospective study where 21 patients admitted to an intensive care unit (ICU) with critical COVID-19 and respiratory failure were treated with RLF-100™(aviptadil) and compared to 24 control patients treated in the same setting. All patients had severe comorbidities that rendered them ineligible for the ongoing randomized controlled phase...

NeuroRx and Relief Therapeutics Announce Fast Track Designation Granted by the FDA to RLF-100 (Aviptadil) for the Treatment of Respiratory Distress in COVID-19 Fast Track Designation of RLF-100 for the treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome associated with COVID-19 underscores the urgent need for new treatment options for these patients. At FDA's request, NeuroRx is submitting an expanded access policy enabling physicians to request RLF-100 for patients who meet this criterion. June 24, 2020 01:30 AM Eastern Daylight Time RADNOR, Pa. & GENEVA--(BUSINESS WIRE)--NeuroRx, Inc. (OTC:RLFTF), in partnership with RELIEF THERAPEUTICS Holding AG (SIX:RLF) “Relief” today announced that...

Gilead Sciences Inc on Wednesday took the unusual step of asking the U.S. Food and Drug Administration to rescind a controversial orphan drug designation the agency had granted for the biotech company’s potential coronavirus treatment remdesivir just 48 hours earlier. The FDA agreed to the withdrawal, and said it is actively working to speed development of medical products desperately needed to prevent or treat the highly contagious COVID-19 illness caused by the virus. Shares of the California-based company closed down nearly 6% at $69.66. The company was criticized by lawmakers and patient advocates after receiving the orphan designation on Monday...

DR. FUDMAN is in private practice in Austin, Texas. He reports that he has no conflicts of interest. The price of colchicine is increasing by 50-fold, from about $0.10 per tablet to $5 per tablet, unless physicians and patients can convince the Food and Drug Administration to allow the colchicine made by generic manufacturers to stay on the market. A twice-daily dose of colchicine will increase from $6/month to $300/month because one company has taken advantage of FDA rules and the orphan drug law to the detriment of patients. Colchicine has technically been an “unapproved drug” rather than a “generic...