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news.Specialist biopharmaceutical company InKine, has submitted an application for US marketing approval of INKP-102, its next generation sodium phosphate tablet designed to aid bowl preparation before colonoscopy.
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The application is based on data from two randomized, multicenter, investigator-blinded clinical trials comparing INKP-102 to Visicol tablets, InKline’s current sodium phosphate treatment. Both a phase II dose-ranging trial and a phase III pivotal trial have been reported.
The trial results indicate that INKP-102 is more effective than Visicol; lower doses of INKP-102 were needed and colon cleansing properties were enhanced. The size of the new purgative tablet makes it easier to swallow than the Visicol formulation, increasing patient acceptance.
The results have allowed Inkine to put forward its FDA application ahead of schedule. The company expects the product to be very successful if marketed. Dr Leonard Jacob, chairman and CEO of InKine said: “Based on the improved efficacy, safety and patient acceptance attributes, we believe that INKP-102, if approved by FDA, will be the best purgative on the market and should significantly expand InKine’s share of the market for colon cleansing products.”
The company has also filed a patent application that, if granted, would protect INKP-102 until 2024.