Cisapride, a drug for severe nighttime heartburn amongst adult patients, is fast losing its market in India with the arrival of gastroprokinetics, mosapride and itopride. The drug had been placed under restricted use by the Drug Controller General of India (DCGI) as per a directive issued to all state drug controllers last year.
According to an industry source, cisapride solids account for a sales of Rs 11crore and a degrowth of 46 per cent per annum, while cisapride liquids sold for Rs 75 lakh and recorded a degrowth of 23.7 per cent. "There is no future for the molecule," the source said. Cisapride combinations have a sales of Rs 6.05 crore but are also degrowing at 40 per cent per annum.
Mosapride has taken off very well and itopride is showing considerable promise. There is only one manufacturer of Itopride in the domestic market which is Abbott India Ltd with its brand Ganaton. As Mosapride came into the market earlier than itopride, it is doing better than Itopride, says a retailer, and the sales are expected to grow further.
(Itopride hydrochloride was originally developed and marketed by Hokuriku Seiyaku Co. since September 1995 as Ganaton tablets. Hokoriku became a subsidiary of Knoll Ag in April 1996. Knoll was acquired by Abbott Laboratories on March 2, 2001.)
Single ingredient Mosapride products have a sales of Rs 17.70 crore and a growth of 234 per cent. Mosapride combinations have a sales of Rs 2.07 crore for which growth figures are not available.
In the Rs 37.93 crore gastrokinetics market which is growing at the rate of 2.7 per cent as per ORG-MARG's September 2002 moving annual turnover figures, Abbott's offering is competing with Mozax of Sun Pharmaceutical Industries Ltd which has a sales of 3.18 crore and is growing at 102 per cent, Moza of Intas Pharmaceuticals Ltd which has a sales of Rs 5.18 crore and a growth of 243 per cent and Ciza (also of Intas) which has a sales of Rs 6.32 crore and a degrowth of 30 per cent.
According to Abbott, the competitors for Ganaton are Mozax, Moza (Intas), Ciza (Intas) and Domstal (Torrent). Domstal is anti-emetic, but used for the same indication as itopride, Abbott says. While Domstal has a sales of Rs15.91 crore and a degrowth of 3.5 per cent, Domstal suspension has registered a sales of 5.46 crore, and a growth of 5 per cent.
Abbott India Limited, a leading company in the gastroenterology market, had launched itopride hydrochloride 50 mg under the brand name Ganaton for the first time in India on July 15 this year.
The marketing approval was received from DCGI in May 2002. It was after, that the erstwhile Knoll Pharmaceuticals Ltd started clinical trials for itopride in India.
Itopride is a gastrokinetic with a unique two-way action which restores gastric natural tone and is a novel prokinetic drug for the treatment of disorders characterized by reduced gastric motility.
According to a comparative study on the effectiveness and safety of itopride versus cisapride in functional dyspepsia, itopride is as effective as cisapride for functional dyspepsia without significant side effects and less active than cisapride in lower gastrointestinal tract.
According to Abbott, Ganaton increases acetylcholine levels in GI system. It has a dual mode of action whereby it inhibits Dopamine D2 receptors and prevents the inactivation of acetylcholine by the enzyme acetycholinesterase.
Abbott does not rule out entry of Indian generic producers into the market with differently processed versions of its research molecule as gastric motility disorders like non-ulcer dyspepsia, gastro-esophageal reflux disease are frequently encountered conditions in clinical practice.
Janssen Pharmaceutica Inc of Titusville, N.J., had stopped marketing cisapride (Propulsid) in the United States by July 14, 2000 after the use of cisapride was associated with 341 reports of heart rhythm abnormalities including 80 reports of deaths till December 31, 1999, the US FDA says.
Most of these adverse events occurred in patients who were taking other medications or suffering from underlying conditions known to increase risk of cardiac arrhythmia associated with cisapride, according to the US FDA.