New Oral Constipation Drug Passes Final Stage of Development
Irritable Bowel Syndrome with Constipation (IBS-C)
It is a most common gastrointestinal disorder. A person having IBS-C suffers from a collection of conditions like abdominal pain, cramp, bloating, constipation and diarrhea. Changes in diet and lifestyle along with medications are often recommended to improve the symptoms as no single therapy can provide relief from all the conditions.
10 to 15 percent people globally suffer from this condition. In the US, more than 11 million people have IBS-C. It is one of the major health problems faced by women. Approximately 60% to 65% women report having IBS compared to 35 to 40 percent male, according to International Foundation for Functional Gastrointestinal Disorders.
Doctors often prescribe laxatives which help to relax the muscles to ease the flow of stool and antispasmodic drugs to relieve stomach cramps, but regular use of these drugs have their own side effects.
Potential New Drug for IBS-C
Biotech Company, Ardelyx’s tenapanor was developed by the internal scientists of the company to work within the gut area exclusively. In the gut, tenapanor blocks the NHE3 transporter which is responsible for the absorption of dietary sodium in the bloodstream.
NHE3 transporter inhibition increases the level of sodium in the gut, elevating the fluid level in the stomach. It loosens stool and helps in relieving constipation.
In the second late-stage development of the drug, it passed the primary objectives of reducing abdominal pain and increasing bowel movement. During the study, tenapanor-treated patients showed 30 percent reduction in the abdominal pain along with more frequent bowel movement compared to those on placebo.
Although the occurrence of diarrhea in tenapanor-treated patients increased slightly (16 percent) than the previous trial, it may not affect the prospect of the drug.
The company is expected to file for the marketing approval for the drug with the U.S. FDA in the second half of 2018. Tenapanor is also being studied to treat cardiorenal diseases in patients like hyperphosphatemia.
Competition in the Market
If tenapanor got approved, it would have to compete with Ironwood Pharma’s Linzess (linaclotide) which is a prescription medicine to treat chronic constipation or chronic IBS in adults. It was approved by FDA in 2012 for the treatment of IBS-C and chronic idiopathic constipation.
Amitiza (lubiprostone) was the first drug approved by FDA for the treatment of IBS-C in women in 2008.
Trulance™ of Synergy Pharma which got approved in January this year for the treatment of chronic idiopathic constipation is also being tested in patients for IBS-C.