The program, called a treatment IND, is designed to help women in the US under 55 years of age who suffer from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and for whom no other treatment has provided satisfactory relief, or patients who had satisfactory improvement of their symptoms with prior Zelnorm treatment for IBS-C or CIC.
The FDA asked Novartis to suspend its marketing of Zelnorm in March 2007 after a retrospective analysis of pooled clinical trial data linked the drug with an increased risk of heart attack and stroke. However, no causal relationship between Zelnorm and cardiovascular ischemic events has been demonstrated, according to the company.
Treatment INDs are generally used to allow restricted access to medications for patients in need if no comparable alternative drug or therapy is available to treat the disease. Patients given access through a treatment IND must meet specific FDA-approved criteria for enrollment.
Through the program, appropriate female patients with IBS-C or CIC who are assessed by their physicians as being in critical need can have access to Zelnorm for relief of the often painful and disruptive symptoms associated with these conditions. The program protocol and consent materials are designed to ensure that patients and physicians are fully informed of the potential risks and benefits of Zelnorm.
To be considered for access to Zelnorm through the treatment IND, patients must have IBS-C or CIC and meet the specific criteria in the treatment IND protocol.