Lupin receives CDSCO approval for indigestion drug acotiamide

Lupin Limited has received approval for acotiamide tablet (100 mg) from the Central Drugs Standard Control Organisation (CDSCO) for the treatment of functional dyspepsia, a chronic disorder of sensation and movement (peristalsis) in the upper digestive tract. Lupin plans to launch the product in India shortly.

Acotiamide is a first-in-class novel drug to be introduced into the Indian Pharmaceutical Market (IPM) which could benefit millions of patients suffering from dyspepsia or indigestion, among the most common stomach complaints encountered in clinical practice. The molecule is a prokinetic agent - a type of drug which enhances gastrointestinal motility. Acotiamide enhances gastric accommodation and gastric emptying, the two factors which have been implicated in the cause of functional dyspepsia. Acotiamide, approved by PMDA Japan, is actively marketed in Japan.

As per the IMS Health data, the current market for plain gastrointestinal (GI) prokinetics and combinations is estimated to be around Rs 2,640 crores growing at 14 percent. The overall GI market is estimated at Rs 11,438 crores which is growing at 13 percent.

According to gastroenterologists, a large number of patients often complain of a common condition that their stomach seems to be overfilled soon after they commence having their meals. This feeling results in the patient being unable to even finish their normal meals; a symptom referred to as early satiety. Some other patients describe the symptom as an unpleasant sensation like prolonged presence of food in the stomach (post meal fullness and discomfort) resulting in excessive bloating and belching. Acotiamide aims to address these common symptoms of dyspepsia (indigestion). Acotiamide is approved for the treatment of post meal fullness, bloating and early satiety in functional dyspepsia by the CDSCO.

Naresh Gupta, president, Lupin Limited, said “We have a rich legacy of having introduced novel treatments to address unmet medical needs in the country. 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.”