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Chelsea announces topline data from Phase II study of droxidopa in fibromyalgia.

M2 PHARMA-December 23, 2011-Chelsea announces topline data from Phase II study of droxidopa in fibromyalgia(C)2011 M2 COMMUNICATIONS

23 December 2011 - Chelsea Therapeutics International Ltd (NASDAQ:CHTP) on Thursday released topline data of a Phase II dose-finding trial intended to assess the safety and determine the potential therapeutic dose range of droxidopa monotherapy or droxidopa plus carbidopa for treatment of fibromyalgia.

The multi-centre, randomised, double-blind, placebo-controlled, dose response, factorial 12-arm parallel group trial, carried in the UK, assessed 120 patients equally randomised to receive droxidopa alone, carbidopa alone, droxidopa/carbidopa combination therapy or placebo.

The primary endpoint was the average reduction in pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ), with secondary goals including Fibromyalgia Index Questionnaire (FIQ) and Visual Analog Scale (VAS).

Topline results indicated a dose response with the highest dose of droxidopa, 600 mg TID, demonstrating a 6.2-point average improvement from a baseline score of 23.00 on the SF-MPQ at the end of the nine-week treatment period. This represents a 3.2 unit improvement over placebo on the SF-MPQ total pain score.

Although the trial was not intended to show statistical significance given the limited number of patients per arm, the results demonstrate a mean change in pain as measured by the visual analogue scale (VAS) of -1.64 for patients treated with droxidopa alone compared to a mean change of -0.90 for placebo. Assessment using FIQ showed patients treated with droxidopa alone demonstrated a mean change from baseline of -9.72 compared to -4.74 reported by patients in the placebo arm. Also, the trial showed that droxidopa as a monotherapy was more efficient than droxidopa/carbidopa combination therapy.

While overall dropouts in the trial were similar to the relatively high discontinuation rates seen in fibromyalgia studies, there were fewer dropouts in the monotherapy arm (29.2%) compared to placebo (46.7%). No serious adverse events occurred with either droxidopa monotherapy or droxidopa/carbidopa combination therapy.

NORTHERA (droxidopa) is Chelsea's most advanced drug candidate. It is an orally active synthetic precursor of norepinephrine originally developed to treat neurogenic orthostatic hypotension.

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Publication:M2 Pharma
Date:Dec 23, 2011
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