Midodrine Update: Opening of a public docket
[1/11/2011] The U.S. Food and Drug Administration (FDA) is announcing the opening of a public docket (FDA-2010-N-0637) to provide a forum to facilitate communication regarding the conduct of clinical trials needed to verify and describe the clinical benefit of midodrine hydrochloride (HCl). Since the approval of midodrine HCl under FDA's Accelerated Approval regulations, the company, Shire, has conducted several clinical studies of the drug, and literature regarding the efficacy of the product has been published, but the data submitted to the agency have not verified the clinical benefit that the drug was expected to have. FDA recognizes that existing and potential sponsors may wish to conduct the clinical trials needed to support continued marketing authorization of midodrine HCl.
To assist sponsors in planning and designing such trials we have provided a brief description of a recommended clinical trial design. The Federal Register notice invites interested parties to submit information to the docket such as any existing controlled studies that verify the clinical benefit of midodrine HCl when used to treat orthostatic hypotension. Physicians who treat orthostatic hypotension and patient organizations that would like to work with any sponsors of new clinical trials are invited to submit correspondence to the docket identifying themselves.
The docket will remain open for written or electronic submissions until July 11, 2011.