The long, strange ride continues for Northera, Chelsea Therapeutics’ candidate to treat orthostatic hypotension in Parkinson’s and other diseases, which was denied approval by the Food and Drug Administration (FDA) today. Those living with orthostatic hypotension — a sudden drop in blood pressure when standing up, which can cause dizziness, falls and injury — will have to continue to wait for a drug.
While the latest decision is clearly not what Chelsea was hoping for, the door may not be completely closed on Northera. The FDA has asked for additional efficacy data from an ongoing clinical trial. According to their press release, Chelsea could be ready to go back to the FDA in the near future.
Northera is the brand name for droxidopa, which has been approved to treat orthostatic hypotension in Japan since 1989.
In mid-February, Chelsea voluntarily released news of safety concerns about the drug (a highly unusual move) and the company lost a third of its market value in the wake of that first announcement. Then, just two days later, an FDA advisory committee recommended that the FDA approve the drug. Stock soared on the strength of the unexpected good news.
Following the advisory committee decision last month, which had ruled 7-4 in favor of Northera being approved, there was speculation that the committee may have been willing to tolerate a somewhat higher level of risk regarding safety given that there was no available treatment for orthostatic hypotension. Usually, FDA rules in line with advisory committee recommendations. Not this time.
In related news, The Michael J. Fox Foundation (MJFF) is funding a separate project on droxidopa investigating its potential to treat cognitive disorders in PD, under our recurring Repositioning Existing Drugs program. The trial is currently in the second phase of clinical testing.