The Ahmedabad-based Cadila Pharmaceuticals (CPL) would be launching the first intravenous (IV) dosage form of the anti-ulcerant drug rabeprazole sodium in the world. The company, which introduced the solid dosage of the drug, Rabeloc, for the first time in the country in 2002, has received the DCGI approval to manufacture and market the IV formulation recently.
Rabeprazole sodium, currently the most advanced anti-ulcerant for duodenal ulcers, gastro ulcers and heartburn (gastroesophageal reflux disease -GERD), with the IV dosage form is advised for severe and life threatening ulcer where patient is having upper gastro-intestinal bleeding. The company will be launching the product under the brand name Rabeloc IV shortly in India.
In the gastro segment, Cadila Pharma is currently a leading player with brands such as Aciloc, Lancus, Domperon, Olit, Morsat and others, which enjoy a significant share of the Rs 445-crore anti-ulcerant market. The company has conducted extensive multicentric clinical trials on rabeprazole at prestigious institutions like AIIMS (All India Institute of Medical Sciences, New Delhi), LTMC (Lokmanya Tilak Medical College, Mumbai), Sion Hospital, Mumbai and V.S. Hospital (Vadilal Sarabhai Hospital), Ahmedabad.
Rabeprazole is an internationally acclaimed molecule, approved by US FDA and WHO under Essential Drugs & Medicine Policy. Currently the drug is available in 21 countries, including US, UK and Japan which is indicated for acid peptic disorders including heartburn (reflux oseophagitis), gastric and duodenal ulcers etc. In the US, rabeprazole is branded as 'Aciphex' and in the rest of the world it is branded as 'Pariet'.
According to company sources, rabeprazole is a blockbuster drug, as compared to the existing anti-ulcerant therapies, in many aspects. It suppresses acid very fast, thereby relieves pain and acidity quickly. Unlike some drugs, which are effective only at day or at night, Rabeloc works in both daytime and nighttime acidity.
As compared to pantaprazole and esomeprazole, which are only approved for heartburn (GERD), Rabeloc is also approved for other disorders including a rare disorder called "Zollinger Ellison Syndrome'. While pantaprazole is approved for short-term therapy (8 weeks therapy), rabeprazole is approved for long-term and short-term therapies and can be safely administered for 52 weeks or more.