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Drug Evaluations

Droxidopa for the treatment of neurogenic orthostatic hypotension and other symptoms of neurodegenerative disorders

, MD PhD, , PharmD, , MD PhD & , MD PhD
Pages 509-522 | Published online: 24 Mar 2014
 

Abstract

Introduction: l-threo-3,4-dihydroxyphenylserine (droxidopa) is a pro-drug that is metabolized to norepinephrine in nerve endings and in other tissues. It has been commercialized in Japan since 1989 for treatment of orthostatic hypotension (OH) symptoms in Parkinson's disease (PD) with Hoehn & Yahr stage III, Shy-Drager syndrome, familial amyloid polyneuropathy and hemodialytic patients. It has also been recently approved by the FDA for symptomatic neurogenic OH.

Areas covered: In this review, clinical uses of droxidopa in neurogenic OH and other neurodegenerative disorders will be reviewed. Results from a MEDLINE search with the keywords ‘droxidopa' or ‘l-threo-3,4-dihydroxyphenylserine' or ‘L-DOPS' will be discussed. Abstracts from international congresses will also be explored.

Expert opinion: Results from a few small and short placebo-controlled trials and clinical studies in neurogenic OH showed significant reductions in the manometric drop of blood pressure after posture changes or meals. Larger Phase III studies suggest a positive effect of the drug on dizziness, which has only been shown in the short term (i.e., < 2 weeks). FDA approval was granted in the context of an ‘accelerated approval program', which means that further studies have to be conducted in order to assess the long-term effects of droxidopa on OH symptoms. Droxidopa has also been studied for the treatment of other causes of OH, other symptoms of Parkinson's disease or other indications. Nonetheless, the results of such pilot studies remain preliminary, as randomized placebo-controlled clinical trials are generally lacking.

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