Tag Archives: low blood pressure

Northera Approved by FDA

Nearly two years ago, I wrote about how the US Food and Drug Administration (FDA) appeared to be ready to approve a new drug for neurogenic orthostatic hypotension (NOH), which, basically, is a precipitous drop in blood pressure upon standing. (I recommend reading that blog as a good primer.) That drug, droxidopa with the brand name of Northera™, did not win approval because of outstanding concerns by FDA. Fast-forward to this week, and FDA has now signaled that it will approve droxidopa for the treatment of NOH.

Understanding the FDA Committee’s Decision to Recommend Approval for Neurogenic Orthostatic Hypotension Drug

From James Beck, Ph.D., Director of Research Programs You may have read the recent news about the small pharmaceutical company,Chelsea Therapeutics, and their drug Northera™ (droxidopa). Chelsea recently received the recommendation of a FDA advisory committee to approve droxidopa as a treatment for neurogenic orthostatic hypotension or NOH for short. This recommendation was a big surprise since FDA documents released ahead of the committee meeting showed that agency staff members were clearly against approval; nevertheless, this approval recommendation will strongly influence the final decision expected to be made later this month. What is NOH? Normally, blood pressure increases as you… read more Read More

WPC Science Day Zero: Orthostatic Hypotension

From James Beck, Ph.D., Director of Research Programs Yesterday, an industry-sponsored session for clinicians and scientists was held prior to the official start of 2nd World Parkinson Congress. Largely a review of current medical management of PD, the session included one tidbit that I found particularly interesting – a comment made by Mark Stacy, M.D. He said that orthostatic hypotension, that is low blood pressure upon standing, is the most common, unrecognized symptom of PD. Up to 40 percent of people with PD experience orthostatic hypotension. Drugs that are currently approved to treat hypotension, like midodrine, work, but may work… read more Read More