INDIA – Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company, today announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir in India.
The study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients, Glenmark said in a statement.
Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects like weakness, gastritis, diarrhea, vomiting among others were found to be mild in nature. The time for fever resolution was 4 days, while the time for the clinical cure was 7 days, it added.
The study was conducted at thirteen sites – both government and private institutions – across Mumbai, Bangalore, Hyderabad, Nashik, Nagpur, and Trivandrum. It was conducted in patients in line with the approved indication of the drug, Glenmark said.
The average age of patients in the study was 40 years, with women comprising 40 per cent and 60 per cent men, it added.
On June 19, 2020, Glenmark became the first company in India to receive restricted emergency use approval from India’s drug regulator for Favipiravir, making it the first oral Favipiravir-approved medication in India for the treatment of mild to moderate COVID-19.
The approval was granted as part of accelerated approval process, considering the emergency situation of the COVID-19 outbreak in India.
“This study was crucial as it examined the safety and efficacy of FabiFlu in real-world settings, where multiple variables can impact the results,” Glenmark Pharmaceuticals, Group Vice President & Head, India Formulations, Alok Malik said.
Despite these factors, the PMS study demonstrated FabiFlu’s consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID-19, he added.
In August, Glenmark Pharmaceuticals and Canadian biotech firm SaNOtize announced an exclusive long-term strategic partnership to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India and other Asian markets.
In March 2021, SaNOtize’s clinical trials showed NONS was a safe and effective antiviral treatment to prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms.
SaNOtize developed and patented a Nitric Oxide Releasing Solution platform technology (NORS™) to treat and prevent microbial infections in 2017. Glenmark’s partnership with SaNOtize will bring in much needed therapeutic relief to patients in India and Asia.