Additional Efficacy Indication Approved for Anti-Parkinsonism Agent DOPS®: Alleviation of Orthostatic Hypotension Symptoms in Hemodialytic Patients
Anti-parkinsonism agent Dops (generic name: droxidopa), which Sumitomo Pharmaceuticals has developed and marketed in Japan since 1989, was approved as of July 3 for an additional efficacy indication: the alleviation of vertigo, staggering, dizziness on standing up, lassitude, and weakness in hemodialytic patients with orthostatic (postural) hypotension.
Dops, an orally administered precursor to the neurotransmitter norepinephrine, is metabolized to norepinephrine in vivo and alleviates norepinephrine deficiency. If patients receiving hemodialysis for their renal insufficiency take Dops before dialysis, the medicine can alleviate the symptoms associated with orthostatic hypotension: vertigo, staggering, dizziness on standing up, lassitude, and weakness.
A common and potentially disabling refractory complication among hemodialytic patients is dysfunction of the autonomic nervous system, which can become even more pronounced as patients grow older. The treatment of neurogenic symptoms associated with norepinephrine deficiency including dizziness, staggering, and general weakness in such patients poses a considerable challenge in daily clinical practice.
Hitherto, symptomatic orthostatic hypotension in dialytic patients has been treated conservatively via gradual change in posture and maintenance of a resting position. There was thus a strong need for medicine to provide effective treatment of orthostatic hypotension symptoms in hemodialytic patients.
It is presumed that symptoms of orthostatic hypotension are caused by the reduced synthesis, neuronal release, and uptake of endogenous norepinephrine due to the malfunction of the vasculo-autonomic system. As the supplementation of norepinephrine appeared to be effective in alleviating such symptoms, Sumitomo Pharmaceuticals has worked on the development of suitable therapeutic agents since 1989. After extensive clinical investigation, Dops has received recent approval for the treatment of orthostatic symptoms in hemodialytic patients. The addition of Dops to the physician's therapeutic armamentarium is expected to contribute to the improvement of the normal daily activities of hemodialytic patients.