The current market for gastrointestinal products is estimated at about Rs.11,438 crore and growing at 13% annually
New Delhi: Lupin Ltd, India’s third largest drug maker, said on Monday that it had received approval from the Central Drugs Standard Control Organisation (CDSCO) to launch a 100mg acotiamide tablet used to treat indigestion. Lupin said it will commence promotion of the product in India shortly.
Acotiamide was developed by Japan’s Zeria Pharmaceutical Co. Ltd and approved by the country’s Pharmaceuticals and Medical Devices Agency, a regulatory agency similar to India’s CDSCO. It was launched in Japan in June 2013 as a therapeutic agent to counter indigestion.
Clinical trials—phase III in Europe and phase II in the US—have also been conducted for the drug.
“Acotiamide is approved for the treatment of post-meal fullness, bloating and early satiety in functional dyspepsia by the CDSCO,” Lupin said in the statement.
The current market for gastrointestinal products is estimated at about Rs.11,438 crore and growing at 13% annually, according to IMS Health’s research report for June.
A study published in April this year by the gastroenterology and hepatology division of the Medical Education Center in the Keio University School of Medicine, Japan, stated that acotiamide had the potential to be a promising drug “because of its efficacy without any significant adverse events”.
According to gastroenterologists, patients often complain of an overfilled stomach soon after beginning their meals—a symptom referred to as “early satiety”. Other symptoms include sensations like prolonged presence of food in the stomach resulting in excessive bloating and belching.
“I am sure that the approval of acotiamide would go a long way in addressing an otherwise common but unmet medical need for a safe and effective drug for the management of dyspepsia,” said Naresh Gupta, president, Lupin Ltd.
“It’s technically a novel drug because it’s being introduced in India for the first time. However, its impact on the market would be less than limited so it’s a non-event,” said a Mumbai-based pharmaceuticals analyst, speaking on condition of anonymity.
A novel drug is any active compound or molecule that has previously not been approved by the country’s drug regulatory body.
Shares of Lupin Ltd fell 2.03% to Rs.1,545.20 at the close on Monday, while the benchmark Sensex fell 0.33% to close at 27,985.54 points.