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Feb. 5, 2014

Public Citizen Calls on FDA to Reject Droxidopa, Proposed New Medication for Sudden Blood Pressure Drop Upon Standing

Trials Provide Insufficient Evidence of Treatment’s Effectiveness

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) should not approve droxidopa, a proposed treatment of neurogenic orthostatic hypotension (NOH) – a disorder marked by feeling faint upon standing up due to a drop in blood pressure, Public Citizen said in a letter to the agency today.

The disorder is associated with several conditions, including Parkinson’s disease and non-diabetic neuropathy.

In 2012, following review of the original new drug application submitted by Chelsea Therapeutics, the FDA concluded that droxidopa should not be approved because data from three randomized controlled studies had shown a lack of evidence that the medication was effective. The FDA told the drugmaker to submit data from an additional trial and emphasized that the study would need to demonstrate “strongly positive” results in order for FDA to approve the drug.

The drugmaker in August 2013 submitted a second application after a fourth randomized, controlled study of the drug had been completed, but there still is not enough evidence to show that the medication is effective for its proposed use. Both the design and conduct of the fourth study were poorly done, Public Citizen said. Furthermore, the minimal effects of the treatment do not appear to last beyond one week, rendering the drug useless for a chronic disorder like NOH.

The FDA’s own clinical reviewer concluded that this fourth study failed to provide the strongly positive results required by the agency and recommended that the agency not approve droxidopa for the treatment of NOH because of inadequate evidence of effectiveness and no proof of durable effect.

“The FDA is obligated to disapprove the drug based on the agency’s own expert review of the evidence,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “The agency’s approval of droxidopa given the available data would undermine the integrity and meaningfulness of its own standard for approving drugs and cause immeasurable harm to the agency’s reputation.”

Read the letter that was submitted to the FDA.


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