InKine Announces Submission of an NDA for Its New Purgative Product
InKine Pharmaceutical has submitted an electronic new drug application (NDA) for U.S. marketing approval of its next generation sodium phosphate tablet, INKP-102.
The NDA is based on data from two randomized, multicenter, investigator-blinded clinical trials comparing INKP-102 to 40 Visicol tablets, including a Phase II dose-ranging trial and a Phase III pivotal trial. Based on the results of these trials, the dose of INKP-102 proposed for marketing is 32 tablets, compared to the approved dose of 40 tablets for Visicol tablets.
The clinical trials indicated that the 32-tablet INKP-102 dose was comparable or significantly superior to 40 Visicol tablets in all tested efficacy parameters, and met the primary efficacy endpoint of noninferiority for the overall colon cleansing response rate in the Phase III trial. In the combined safety database, the 32-tablet INKP-102 dose was significantly superior to Visicol tablets in several key safety parameters.
In the Phase III trial, patient acceptance was significantly greater with INKP-102 compared to patients who took Visicol tablets. Significantly more patients who took 32 INKP-102 tablets indicated that they would be willing to take the same preparation again for a future colonoscopy compared to those who took Visicol tablets. Results in the Phase II trial were supportive.