Romark has reported that initial results from a Phase III clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets, 300mg) demonstrated to reduce disease progression in mild or moderate Covid-19 patients.
Drug major Lupin NSE 2.51 % on Wednesday said it has launched Nitazoxanide tablets (500 mg), used to treat diarrhea, in the US market.
The U.S. Food and Drug Administration (FDA) has approved Romark’s manufacturing facility in Manati, Puerto Rico for the production of Alinia (nitazoxanide) tablets, 500 mg and Alinia (nitazoxanide) for Oral Suspension, 100 mg/5mL in the U.S. market.
The Orphan Drug Act of 1983 was passed to promote the development of rare disease treatments. To qualify for incentives under the act, sponsors must first receive “orphan drug designation” from the Food and Drug Administration (FDA). In almost all cases, the FDA grants an orphan drug designation because the disease treated by the drug affects 200,000 or fewer Americans. Most orphan-designated drugs are never FDA-approved to treat a rare disease; those that have at least one such approval are called “orphan drugs.”
A new study published on the preprint server medRxiv* in May 2020 reports a model that could help evolve appropriate dosage protocols for future clinical trials of the repurposed drug nitazoxanide in COVID-19 prevention and treatment. The researchers say, “It was possible to achieve plasma and lung tizoxanide concentrations, using proven safe doses of nitazoxanide, that exceed the EC90 for SARS-CoV-2.”
Romark announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
TAMPA, Fla., April 27, 2020 /PRNewswire/ -- Romark announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
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