What is the Zelnorm treatment IND program?
This program, called a “treatment IND,” allows restricted access to Zelnorm if there is no comparable alternative drug or therapy available to treat the disease in the intended patient population. Under the Zelnorm treatment IND program, female patients with IBS-C or CIC will be considered to receive the medication if they meet the FDA approved criteria. Who will qualify for the Zelnorm treatment IND program? To be considered for access to Zelnorm through the treatment IND, female patients under 55 with IBS-C or CIC must meet the specific criteria outlined in the treatment IND protocol approved by the FDA. What about patients who do not qualify for the Zelnorm treatment IND? There may be an alternative access option available through the FDA for patients who do not meet the criteria of the treatment IND but have an urgent need for Zelnorm based on a life-threatening or severely debilitating condition. Physicians may inquire about this potential access option by contacting the FDA CDER
