FDA approves Ibsrela to reduce the global burden of Irritable Bowel Syndrome

Recently the U.S. Food and Drug Administration has recommended the use of Ibsrela (tenapanor), for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.
A 50 mg, twice daily oral pill, Ibsrela is a small molecule that acts locally in the gastrointestinal tract to inhibit the sodium-hydrogen exchanger NHE3. The approval came after the positive results based on data from two phases 3, randomized, double-blind, placebo-controlled trials.

Irritable Bowel Syndrome (IBS), also known as spastic colon, irritable colon, mucous colitis, and spastic colitis, is a long-term digestive system condition, resulting in cramping, abdominal pain, bloating, gas, and diarrhoea or constipation, or both.

In layman’s terms, it is the belly pain (abdominal pain) associated with constipation.

According to the National Institute of Health, Irritable bowel syndrome incidence is calculated to be around 1 in 5 people, and it usually first develops when a person is between 20 and 30 years of age. Moreover, in the US, as many as 13 million adults suffer from irritable bowel syndrome with constipation.

Irritable Bowel Syndrome is known to affect twice as many women as compared to men.

Management of Irritable Bowel Syndrome consists primarily of providing psychological support and recommending dietary measures.

Although a few FDA-approved medications like Linzess (Ironwood Pharmaceuticals), Trulance (Synergy Pharmaceuticals), Bentyl (Axcan Scandipharm), Amitiza (Sucampo Pharmaceuticals) are available to treat IBS symptoms, several of these drugs have strict limitations on use. Many patients do not find complete symptomatic relief, even when physicians explore off-label drug options.

Key players such as Redhill Bio, Ardelyx Inc. and others are involved in the development of IBS therapies. The launch of emerging therapies such as BEKINDA by Redhill Bio and Tenapanor by Ardelyx Inc. will significantly impact the Irritable Bowel Syndrome market during the forecast period (2019-2028).

Apart from these therapies, there are other promising IBS candidates as well, which are being developed for the treatment of Irritable Bowel Syndrome.

Few of such drug molecules include Vibegron developed by Urovant Sciences GmbH, Blautix by 4D pharma plc and Rifamycin SV-MMX developed by Cosmo Technologies Ltd. However, these molecules are currently in early Phase-II stage of development. Hence, it is too soon to predict their future during the forecast period (2019-2028).