CHELSEA REPORTS RESULTS OF ORTHOSTATIC HYPOTENSION TRIAL

Chelsea Therapeutics International has reported the preliminary results of a European Phase IIb trial of Droxidopa, an orally available synthetic amino acid for the treatment of neurogenic orthostatic hypotension, a disorder resulting from a deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart.

The primary objective of the trial was to determine the optimal dose of Droxidopa in the treatment of orthostatic hypotension in patients with multiple system atrophy (MSA) or Parkinson's disease. The double-blind, randomized, placebo-controlled, parallel-group, Phase IIb trial was conducted at 30 centers in the EU and significantly expands the body of clinical data available in non-Asian populations. The trial consisted of 125 randomized patients with 121 patients enrolled in the intent-to-treat population for efficacy evaluation. Patients received either placebo or Droxidopa three times daily for 28 days in doses ranging from 100 to 300 mg.

Statistical significance in reducing the fall in orthostatic systolic blood pressure (SBP) was demonstrated at 300 mg with the difference in SBP being 11.6 mmHg between the groups. Results of the trial further validated the excellent tolerability of Droxidopa, which exhibited no difference in the incidence or severity of adverse events or laboratory values when compared with placebo, according to the company. Data from the trial further suggested that concomitant medications such as dopamine decarboxylase inhibitors, a mainstay in both Parkinson's and MSA therapy, did not limit the therapeutic benefit of Droxidopa.

Chelsea acquired development and commercialization rights to Droxidopa through an exclusive license agreement with Dainippon Sumitomo Pharma. As part of its development strategy for Droxidopa, Chelsea has filed an application for orphan drug designation in the U.S. and Europe.