International Phase II trial of novel non-opioid FM pain drug to recruit female Patients – in UK and Australia

The Tokyo-based Sosei Group biopharmaceutical company announced on October 17, 2006 that AD 337, “a novel enantiomer of an approved centrally acting non-opioid analgesic,” has entered a Phase II “proof of principle” trial for the treatment of Fibromyalgia syndrome (FMS).

The trial, apparently focused on sites in the UK and Australia, is listed as NCT00377039 by ClinicalTrials.gov. It will involve four weeks of treatment for approximately 100 female Fibromyalgia patients ages 18 to 65. Its official title: “A multicenter Trial to Determine the Efficacy and Safety of AD-337 in the Treatment of Firbromyalgia.”

For study details, eligibility criteria, and trial site/contact information, go to http://clinicaltrials.gov/ct/show/NCT00377039?order=3

Following is a bit of background information, taken from the Sosei press release:

n The trial is a multi-centre, randomised, double-blind, placebo controlled, parallel group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of Fibromyalgia in female subjects.

n The trial will involve the recruitment of some 100 patients in up to 20 centres in the UK and Australia. Earlier single and multiple dose Phase I studies in a total of 49 subjects showed that AD 337 is “well tolerated with an attractive pharmacokinetic profile.”

n AD 337 is a serotonin noradrenalin reuptake inhibitor (SNRI) and exhibits comparable pharmacology to drugs that are showing promising results in FMS, and has demonstrated antidepressant and anxiolytic [anti-anxiety] activity. In addition, AD 337 is expected to have a low-incidence of drug-drug interaction, a highly desirable characteristic in members of this therapeutic class. AD 337 is also being considered for use in other indications.

n The aetiology of Fibromyalgia syndrome is not well understood but serotonin (5-HT) and noradrenalin (NA) dysfunction is believed to be a contributory factor. Currently there are no drugs specifically approved for FMS although some treatments are available to deal with various Fibromyalgia symptoms.

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