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Phase II trial of non-opioid pain drug to recruit 100 FM Patients in UK and Australia

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www.ProHealth.com • November 7, 2006


Phase II trial of non-opioid pain drug to recruit 100 FM Patients in UK and Australia

“Sosei Announces Start of Phase II Trial of AD 337 in Fibromyalgia Syndrome”

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).

According to Sosei:

The trial is a multi-centre, randomized, 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.

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.”

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.

…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.

Interested parties may find contact numbers for Sosei in New York City, London, and Tokyo at Sosei site at http://www.sosei.com/en/contact/index.html




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