Constipation is a common functional GI disorder that is most prevalent in the elderly and female population and is characterized by lumpy or hard stools, straining, low back pain, pain on defecation, rectal bleeding, abdominal bloating, and feeling of incomplete defecation. The disease can have significant adverse effects on the health and quality of life, which may further lead to psychological and social distress.
CONSTIPATION DRUG CANDIDATES UNDER DEVELOPMENT (2017)
Some of the factors associated with constipation are inadequate fluid intake, poor dietary habits, medication, endocrine issues, and psychological issues. Blood test, sigmoidoscopy, colonoscopy, anorectal manometry, balloon expulsion test, colonic transit study, defecography, and MRI defecography are some of the test for the diagnosis of the disease. Some of the treatment options for constipation are fiber supplements, stool softeners, and secretagogues (lubiprostone and linaclotide). Another treatment option is medication, which helps in drawing water into the intestines to soften the stools and in maintaining bowel movements.
The constipation therapeutics pipeline comprises of approximately 18 drug candidates in different stages of development. Most of the drug candidates being developed by many companies for the treatment of constipation are in the late stage of development (Phase III and II stages) and there is a high chance of witnessing growth in the constipation therapeutics pipeline as many drugs in the pipeline are showing positive clinical results.
Many drug candidates have shown positive clinical results and are proceeding further toward development. For instance, Synthetic Biologics Inc. reported that the second Phase II clinical trial of its proprietary SYN-010 for the treatment of IBS-C met its primary endpoint. Top-line data from all patients who completed the second Phase II clinical trial of SYN-010 showed a statistically significant decrease in methane production (p=0.002) from the beginning of the first Phase 2 study (Study 1 baseline - Day 1) to the end of the second Phase II study (12 weeks of treatment - Day 84), thus meeting the study's primary endpoint. There were no serious adverse events observed. Top-line data from the second Phase II study also showed improvements in secondary efficacy endpoints. Therefore, positive clinical results can be viewed as a positive factor for the growth of the constipation therapeutics pipeline.
Some of the players involved in the development of drug candidates for the treatment of constipation are Nordic Life Science Pipeline Inc., Enterin Inc., and Yuhan Corporation Ltd.