SOSEI BEGINS TRIAL OF TREATMENT FOR FIBROMYALGIA SYNDROME

Sosei has announced 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 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group exploratory study to investigate the efficacy, safety and tolerability of AD 337 in the treatment of FMS in female subjects. The trial will involve the recruitment of approximately 100 patients in up to 20 centers in the UK and Australia.

Single- and multiple-dose Phase I studies in a total of 49 subjects have showed that AD 337 is well-tolerated with an attractive pharmacokinetic profile. AD 337 is a serotonin noradrenalin reuptake inhibitor (SNRI) that has demonstrated antidepressant and anxiolytic 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.

Fibromyalgia syndrome predominantly affects women between the ages of 35 and 60 with an estimated prevalence of 2 percent in the U.S. The disease is characterized by widespread musculoskeletal pain. The cause of the syndrome is not well-understood, but serotonin (5-HT) and noradrenalin dysfunction is believed to be a contributory factor. Currently there are no drugs specifically approved for FMS, although some treatments are available to treat various symptoms.