Parkinson’s patients suffering from orthostatic hypotension — a sudden drop in blood pressure when standing up, which can cause dizziness, falls and injury — scored a victory today when the U.S. Food and Drug Administration (FDA) approved the drug Northera.
The FDA wrote in a press release:
The FDA is approving Northera under the accelerated approval program, which allows for approval of a drug to treat a serious disease based on clinical data showing that the drug has an effect on an intermediate clinical measure (in this case, short-term relief of dizziness) that is reasonably likely to predict the outcome of ultimate interest (relief of dizziness during chronic treatment) ...
Northera has a boxed warning to alert health care professionals and patients about the risk of increased blood pressure while lying down (supine hypertension), a common problem that affects people with primary autonomic failure and can cause stroke. It is essential that patients be reminded that they must sleep with their head and upper body elevated. Supine blood pressure should be monitored prior to and during treatment and more frequently when increasing doses.
Northera is the brand name for droxidopa, which has been approved to treat orthostatic hypotension in Japan since 1989. It was a long journey for the drug candidate from Chelsea Therapeutics; the FDA denied approval and asked for more efficacy data in 2012. The results later that year were mixed.
Symptoms like orthostatic hypotension fall into the category of autonomic dysfunction that affects many people living with Parkinson’s disease (PD). The autonomic nervous system controls “automatic” muscle movements — like heart beat and breathing — that keep us alive. The Michael J. Fox Foundation is hosting a Webinar on autonomic dysfunction in PD this Thursday, February 20 at 12 p.m. ET. Register now.
Also, MJFF is funding a separate Phase II study on droxidopa investigating its potential to treat cognitive impairment in PD. Read more.
Learn more about other drugs in the development pipeline MJFF is supporting.