The new Parkinson’s disease treatment developed by Chelsea Therapeutics (NASDAQ:CHTP) has been submitted to regulators for approval and the company is seeking an expedited review.
Charlotte, North Carolina-based Chelsea filed the new drug application for Northera on Wednesday. Chelsea already has orphan drug status on Northera, its lead drug candidate. In its NDA filing, the company also requested Northera receive priority review, which could lead to a U.S. Food and Drug Administration decision on the drug as soon as the first quarter of next year.
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Northera has been studied as a treatment for neurogenic orthostatic hypotension, or NOH, a sudden drop in blood pressure that can result in lightheadedness and fainting that is common among Parkinson’s patients. Earlier this year, the FDA recommended that Chelsea not seek a claim for Northera’s ability to reduce falls in Parkinson’s patients in the initial labeling. Pending the outcome of additional studies, fall reduction could be added to Northera’s labeling after its approval.
Orphan drug status for Chelsea’s compound was granted by the FDA in 2007. That designation is reserved for drugs that address serious conditions where there is an unmet medical need. Only one FDA-approved product treats orthostatic hypotension. But that product, Shire Development’s ProAmatine, received a black box warning because the drug carries the risk of raising a patient’s blood pressure. Shire decided last year to withdraw its product from the market rather than conduct the additional clinical tests the FDA had requested for the drug.
Droxidopa, the drug that is now Chelsea’s Northera, was developed by and licensed from Japanese pharmaceutical company Dainippon Sumitomo Pharma. In 1989, Japan’s regulators approved droxidopa for treating conditions including frozen gait and dizziness on standing associated with Parkinson’s disease as well as orthostatic hypotension. In 2000, Japan expanded the drug’s marketing approval to include prevention of vertigo, dizziness and weakness associated with orthostatic hypotension in hemodialysis patients.
