An announcement was made on Monday by Alfasigma USA Inc., which has a commercial center in Bedminster, that it has acquired the brand Zelnorm, a prescription pharma treatment for irritable bowel syndrome with constipation, from Sloan Pharma S.à r.l., which is a subsidiary of the United States WorldMeds Holdings LLC.
Alfasigm USA intends to relaunch Zelnorm in the United States & the plans are at presently underway
Initially approved in 2002 as the first prescription medication for irritable bowel syndrome with constipation, Zelnorm was withdrawn voluntarily from the market in 2007 because of concerns regarding potential cardiovascular risk. However, the drug has remained available in the United States through an advanced access program authorized by the Food and Drug Administration.
At the beginning of 2019, Zelnorm got approval by the Food and Drug Administration for reintroduction for use in adult women aged below 65 with irritable bowel syndrome with constipation. The approval to reintroduce Zelnorm came after a detailed safety review by the Food and Drug Administration and an FDA-assembled Gastrointestinal Drugs Advisory Committee which consisted of a review of the clinical data from 29 placebo-controlled trials & post-marketing treatment outcomes data.
President, as well as, Chief Executive Officer at Alfasigma USA, Bryan Downey stated that the firm is excited by the opportunity to make Zelnorm once again available to healthcare providers for the treatment of adult women in the United States suffering from irritable bowel syndrome with constipation. There is a significant unmet need for irritable bowel syndrome with constipation therapies with reliable effectiveness, comparable safety, and that help addressing the debilitating pain, as well as, bloating associated with the disease. They are looking forward to making this effective IBS-C treatment available to the patients who may take advantage of it.