"Even though Shire no longer generates revenue from midodrine, we've agreed to invest more time and resources in additional clinical trials because we know it's the right thing to do for patients," added Jonas. "Preliminary work on these two midodrine trials is underway and we anticipate completion in the first half of 2014."
With the 1996 Subpart H accelerated approval of midodrine for the treatment of SOH came a post-approval commitment by Shire to conduct two clinical trials to verify and describe the clinical benefit of midodrine HCI. The initial approval was based on midodrine's demonstrated ability to significantly raise blood pressure in patients with SOH. In 2000, Shire acquired the medicine and completed two clinical post-marketing trials as required and submitted the results to FDA in 2005. FDA took the position that those two trials were inadequate and requested that additional trials be completed. The agreement of the two additional clinical trials announced here is the outcome of the FDA request following the Shire submission of the 2005 data.
Important Safety Information
Warning: Because ProAmatine® can cause marked elevation of supine blood pressure, it should be used in patients whose lives are considerably impaired despite standard clinical care. The indication for use of ProAmatine® in the treatment of symptomatic orthostatic hypotension is based primarily on a change in a surrogate marker of effectiveness, an increase in systolic blood pressure measured one minute after standing, a surrogate marker considered likely to correspond to a clinical benefit. At present, however, clinical benefits of ProAmatine®, principally improved ability to carry out activities of daily living, have not been verified.CONTRAINDICATIONS ProAmatine® is contraindicated in patients with severe organic heart disease, acute renal disease, urinary retention, pheochromocytoma or thyrotoxicosis. ProAmatine® should not be used in patients with persistent and excessive supine hypertension. Please see Full Prescribing Information . You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.FDA.gov/medwatch or call 1-800-FDA-1088 Notes to editors
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