After announcing positive results from its second phase III trial, Global Data Healthcare Analysts' Maria Sudul said Ardelyx's Tenapanor is in line to make a "successful market entry."
Here's what you should know:
1. Tenapanor's first phase III trial failed to improve individual bowel movement rates, the study's secondary endpoint.
2. Tenapanor conducted a second phase III trial. Researchers found the combined responder rate for six of 12 weeks demonstrated that 36.5 percent of Tenapanor patients had at least a 30 percent reduction in abdominal pain and increased spontaneous bowel movements for at least six of the 12-week treatment period.
3. Tenapanor patients experienced an increase in diarrhea when compared with a placebo. Diarrhea is an adverse event of most IBS-C therapies.
4. Tenapanor reached statistical significance for the study and in abdominal pain responder rates. Tenapanor had a consistent response across 26 weeks of the study.