HYDERABAD: The Hyderabad-based Hetero Drugs on Friday announced the interim results from Phase-III clinical trials of the drug Molnupiravir for treatment of mild Covid-19 patients and said it is seeking emergency use authorisation for the drug from the Drug Controller General of India.
The company, in a press release on the matter, informed that the Phase-III clinical trials were conducted at different sites across the country and involved 741 mild Covid-19 patients.
It said that earlier clinical improvement was observed among patients on Molnupiravir as compared to the control group. The median time to clinical improvement was eight days in the Molnupiravir group, as compared to 12 days in the control group.
Hospitalisations were fewer in the Molnupiravir group (1.89 percent) as compared to the control group (6.22 percent) and earlier RT-PCR negativity was also observed in the Molnupiravir group.
All adverse events reported in the Molnupiravir group were of non-serious nature, mild in severity and none led to drug discontinuation. The most common adverse events reported were nausea, diarrhoea and headache which were resolved completely.
The patients were provided Hetero’s Molnupiravir capsules of 800 mg dose -- four doses of 200mg medicine -- every 12 hours (twice daily) for five days, within five days of onset of the disease.
Hetero had entered into a non-exclusive licensing agreement with the firm Merck & Co to manufacture and supply Molnupiravir in India and over 100 low and middle-income countries.
Hetero is also undertaking a separate Molnupiravir study on moderate Covid-19 patients approved by the Central Drugs Standard Control Organisation (CDSCO).