Arakis completes Phase I trials of AD 337 in fibromyalgia syndrome

02-Nov-2005

Sosei Co. Ltd announced that its wholly-owned subsidiary Arakis Ltd, has successfully completed Phase I single and multidose studies of AD 337, a novel enantiomer of an approved centrally acting non-opioid analgesic, which is under investigation for the treatment of fibromyalgia syndrome. AD 337 has been shown to have activity against central monoamines which are thought to be implicated in the pathogenesis of fibromyalgia. The multidose trial was a double blind, randomised, placebo-controlled, dose escalation study to evaluate the pharmacokinetics, safety and tolerability of multiple oral doses of AD 337 in healthy volunteers and comprised two groups of ten subjects.

AD 337 was observed to be well tolerated. Two earlier single dose studies, involving a total of 28 subjects, showed that the PK profile of AD 337 appeared to be linear and almost proportional to dose over the administered range. Preparations are now underway to initiate a Phase II proof of principle (PoP) trial in the first half of 2006 in patients with active fibromyalgia.

Fibromyalgia syndrome is a poorly diagnosed condition affecting predominantly women with an estimated prevalence of 2% in the USA. The disease is characterised by widespread musculoskeletal pain that presents with a number of co-morbidities including fatigue, sleep disturbance and depression. The aetiology of the syndrome is not well understood but serotonin (5-HT) and noradrenalin (NA) dysfunction is believed to be a contributory factor. There are no drugs specifically approved as yet for fibromyalgia.

The global market for current fibromyalgia treatments is worth some $300m and is expected to grow to over $1 billion in the next 10 years as new therapeutic options become available.

https://www.bionity.com/en/news/49945/arakis-completes-phase-i-trials-of-ad-337-in-fibromyalgia-syndrome.html