FDA approves Northera (droxidopa) for neurogenic orthostatic hypotension

By Reuters Staff

COPENHAGEN (Reuters) - Lundbeck said on Tuesday its drug Northera (droxidopa) for the treatment of neurogenic orthostatic hypotension has been approved by the U.S. Food and Drug Administration and the capsules are available to the country's market through specialty pharmacies.

On its website, the FDA said it 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 about supine hypertension, a common problem in patients with primary autonomic failure. Patients must be reminded to 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, the FDA says.

The most common adverse events in patients taking Northera were headache, dizziness, nausea, hypertension, and fatigue.

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