After an initial rejection in 2012, the FDA has now approved Chelsea Therapeutics International Ltd's drug Northera, lending further stature to both the pharmaceutical giant and the medication that treats dramatic drops in blood pressure.
Typically used for sufferers of Parkinson's and other neurological conditions which act as the catalyst for plummeting blood pressure, Northera (known generically as droxidopa) was previously tabled for FDA approval in 2011. In March of the following year, the agency declined to give the drug the go-ahead, with an advisory panel requesting additional details from Chelsea Therapeutics in order to proceed. The pharmaceutical company obliged, evaluating the drug's performance over a two-week clinical trial. Northera was tested alongside placebos, with the patients taking Northera demonstrating relief from reported symptoms, including dizziness, blurred vision, fatigue, and fainting spells. Though the results of the two-week study yielded a positive future for the drug, Chelsea Therapeutics will continue to test Northera for long-term efficacy. The FDA's approval is 'accelerated,' enabling medical practitioners to prescribe the drug despite ongoing trials.
As tests are continuing, Northera's packaging will be emblazoned with a boxed warning - the most serious of its kind - due to the increased likelihood of supine hypertension in patients. Supine hypertension, a type of increase blood pressure, occurs when lying down, placing patients at risk of a stroke. As a result, those taking Northera are being urged to sleep with their heads and upper bodies raised.
Despite the potential risk, the FDA's approval of Northera is a milestone for sufferers of symptomatic neurogenic orthostatic hypotension (NOH). Symptomatic NOH, the rare type of low blood pressure that Northera treats, is notorious for its lack of treatment avenues. Indeed, no new alternatives have been made available for some twenty years. Dr. Robert A. Hauser, Director of the Parkinson's Disease Movement Disorders Center and Professor of Neurology, Molecular Pharmacology, and Physiology at the University of South Florida, welcomed the FDA's decision. "Symptomatic NOH is a commonly debilitating disorder with limited treatment options and no new therapeutic choices introduced in nearly two decades," said Hauser. "Northera has a distinct mechanism of action affecting the root cause of NOH and represents an important new treatment choice for patients... I look forward to offering this new and novel treatment approach to patients who may benefit from it."
Chelsea Therapeutics also stands to benefit financially from the FDA's clearance of Northera, with company shares jumping to $6.63 apiece - a 34 percent leap - in after-market trading.
