FDA approves treatment for neurogenic orthostatic hypotension

FDA has approved droxidopa (Northera, Chelsea Therapeutics) capsules for the treatment of neurogenic orthostatic hypotension (NOH).

NOH is a rare, chronic and often debilitating condition that is associated with Parkinson's disease, multiple-system atrophy, and pure autonomic failure. Symptoms of NOH include dizziness, lightheadedness, blurred vision, fatigue, and fainting upon standing. 

FDA is approving droxidopa 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). Droxidopa received orphan-product designation from FDA.

“The approval of Northera targets a rare and serious condition, which has the ability debilitate certain individuals, but this drug offers the potential for improved quality of life,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Droxidopa has a boxed warning to alert healthcare professionals and patients about the risk of supine hypertension, a common problem that affects people with primary autonomic failure and can cause stroke. Patients must 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.

Headache, dizziness, nausea, hypertension, and fatigue were the most common adverse events reported by clinical trial participants taking droxidopa.

The effectiveness of droxidopa was demonstrated through two weeks of treatment in two clinical trials in people with NOH. People taking droxidopa reported a decrease in dizziness, lightheadedness, feeling faint, or feeling as if they might black out compared to those taking placebo. Durability of the improvement in patient symptoms beyond two weeks has not been demonstrated.