Ardelyx announced that Tenapanor, a treatment for irritable bowel syndrome with constipation, completed the safety extension portion of its phase III T3MPO program.
Here's what you should know:
1. People who completed either of the first T3MPO phase III studies were eligible for the safety extension study, T3MPO-3.
2. Tenapanor was well-tolerated among the 240 patients that were studied.
3. Of the 240 patients, 9.2 percent experienced diarrhea, with only 1.7 percent of patients discontinuing the treatment because of diarrhea.
4. Throughout all the clinical trials, overall discontinuation rate was only 2.1 percent.
5. Ardelyx plans to submit positive results from the first two T3MPO trials, along with extensive safety data, to the FDA in the second half of 2018 for approval.