Jubilant has sought authorisation for additional studies for this novel oral formulation from the DCGI
Jubilant Pharma, a subsidiary of Jubilant Pharmova, has announced successful completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of remdesivir against the commercially available injectable formulation of remdesivir.
Jubilant has sought authorisation for additional studies for this novel oral formulation from the Drug Controller General of India (DCGI). Jubilant is hoping to provide an affordable, more convenient, easy-to-administer and potentially effective treatment option for COVID-19 patients. The proposed oral treatment is expected to be for five days, a duration similar to the injectable dosage form.
Remdesivir is the first and the only anti-viral drug fully approved by the US FDA for the treatment of patients with COVID-19 requiring hospitalisation.
This innovative formulation is likely to ease the capacity constraint that injectable formulation faces and ensure wider and timely availability for the patients of COVID-19.
It is specifically designed to avoid hepatic metabolism which results in almost complete first-pass clearance/elimination of remdesivir when it is administered by the traditional oral route. The findings from both preclinical and human studies indicate that the drug can undergo absorption when administered using the novel oral formulation. The novel formulation was well tolerated by all the study subjects with no additional safety/ tolerability profile as compared to the injectable product.