"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.
Shire Reaffirms Support Of Patients Requiring Midodrine HCl; Advances FDA Agreed Upon Clinical Trials
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