Ardelyx's Adjusted Trial Design May Expedite NDA Filing For Lead Candidate
This article was originally published in The Pink Sheet Daily
The first-in-class NHE3 inhibitor tenapanor is in Phase III for IBS-C, as well as in Phase II for hyperphosphatemia in end-stage renal disease patients. Agreement with FDA may accelerate filing for the latter indication.
You may also be interested in...
New Phase III study of tenapanor in hyperphosphatemia will include an active control arm for safety monitoring, per US FDA guidance, slightly lengthening timeline.
Although rate of diarrhea was higher for first-in-class tenapanor compared to phosphate binders in the first pivotal trial, drop-out rate is what counts and that was lower, say analysts, happy with the overall dataset.
Plecanatide met the primary endpoint in first Phase III trial in irritable bowel syndrome with constipation, with less incidence of diarrhea than seen in Linzess trials. Synergy is awaiting approval in chronic idiopathic constipation and appears on pace to file an sNDA in IBS-C during the first quarter.