Lundbeck announces availability of NORTHERA™ (droxidopa) capsules in the U.S. for symptomatic neurogenic orthostatic hypotension

Lundbeck announced today that NORTHERA™ (droxidopa) capsules for oral use are now available for healthcare providers to prescribe in the United States. NORTHERA, a norepinephrine prodrug, was recently approved by the U.S. Food and Drug Administration, and is now available across the United States through a specialty pharmacy.²

NORTHERA is approved for the treatment of orthostatic dizziness, lightheadedness, or the "feeling that you are about to black out" in adult patients with symptomatic neurogenic orthostatic hypotension (NOH) caused by primary autonomic failure (Parkinson's disease, multiple system atrophy, and pure autonomic failure), dopamine beta-hydroxylase deficiency, and non-diabetic autonomic neuropathy. Effectiveness beyond two weeks of treatment has not been demonstrated. The continued effectiveness of NORTHERA should be assessed periodically.³

NORTHERA is the only FDA-approved therapy for this condition and carries a boxed warning for supine hypertension. There are other serious risks associated with NORTHERA including hyperpyrexia and confusion, cardiovascular risk and allergic reactions. The most common adverse events in NORTHERA-treated patients in controlled clinical trials were headache, dizziness, nausea, and hypertension. For more information, please refer to the Important Safety Information below.³

"For people living with symptomatic NOH, the availability of NORTHERA may provide a new treatment option to discuss with their healthcare provider," said Staffan Schüberg, president of Lundbeck in the U.S. "As a company with a long-standing and proven track record of working closely with smaller patient populations facing considerable unmet medical needs, we are passionate about delivering this needed therapy to patients and their families."

Symptomatic NOH is a rare autonomic nervous system disorder associated with failure to release adequate amounts of norepinephrine upon standing.⁴ NOH is caused by an underlying autonomic neurologic disorder, such as Parkinson's disease, multiple system atrophy, or pure autonomic failure.¹ Norepinephrine deficiency may result in an inability for a person to maintain adequate blood pressure and blood flow to the brain upon standing, resulting in dizziness, lightheadedness, and the "feeling that you are about to black out."

"While the exact mechanism of action in the treatment of neurogenic orthostatic hypotension is unknown, NORTHERA is a prodrug that is directly metabolized to norepinephrine, the naturally occurring neurotransmitter of the sympathetic nervous system,"3 said Horacio Kaufmann, M.D., lead investigator of the NORTHERA pivotal trial. "I'm pleased that patients who have symptomatic NOH will now have another treatment option to discuss with their physician."

"Our entire community of patients rallied to help ensure NORTHERA gained FDA approval, and we're delighted that it's now available throughout the U.S.," said Judy Biedenharn, president of the Multiple System Atrophy (MSA) Coalition.