Pharma

Chelsea’s Northera for Parkinson’s patients gets FDA priority review

Chelsea Therapeutics‘ (NASDAQ:CHTP) drug candidate for dizziness and fainting in Parkinson’s disease patients has been […]

Chelsea Therapeutics‘ (NASDAQ:CHTP) drug candidate for dizziness and fainting in Parkinson’s disease patients has been accepted for priority review by the U.S. Food and Drug Administration.

Priority review is reserved for drugs that either offer a major advance in treatment, or provide treatment where no adequate therapy exists. The drug candidate, Northera, already has orphan drug designation. An FDA decision whether to approve Northera’s new drug application is expected by March 28.

Charlotte, North Carolina-based Chelsea has been studying Northera as a treatment for neurogenic orthostatic hypotension, or NOH. The sudden drop in blood pressure from NOH can can result in lightheadedness and fainting, and is common in Parkinson’s patients. The compound received orphan drug status in 2007. The only FDA-approved drug to treat NOH has been withdrawn from the market. Shire‘s (NASDAQ:SHPGY) ProAmatine carried  a black-box warning due to risks it could raise a patient’s blood pressure. The company last year decided to pull the product rather than conduct the additional tests on the drug requested by the FDA.

Northera was developed by Japanese pharmaceutical company Dainippon Sumitomo Pharma. The company’s product, Droxidopa, was approved by Japan’s regulators in 1989 for treating frozen gait and dizziness on standing associated with Parkinson’s disease as well as orthostatic hypotension. In 2000, Japan expanded Droxidopa’s marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.

Chelsea licensed Droxidopa in 2006 and has global commercialization rights for the drug outside of Japan, Korea, China and Taiwan. Called Northera by Chelsea, the compound is now the company’s lead drug candidate. Besides treating NOH, Chelsea also studied Northera’s ability to reduce falls in Parkinson’s patients. The FDA earlier this year recommended that in the initial labeling, Chelsea should not seek a claim about reducing falls. Depending on the outcome of additional studies, fall reduction could be added to Northera’s labeling after approval.

Chelsea is also studying droxidopa as a potential treatment for fibromyalgia. That drug program is in phase 2 clinical trials. The company has said that droxidopa also has potential applications in treating attention-deficit/hyperactivity disorder.

Photo from Flickr user IsaacMao

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