Fibromyalgia is a musculoskeletal pain and fatigue disorder for which the cause is still unknown.
The trial will investigate the efficacy, safety and tolerability of AD 337 in the treatment of fibromyalgia in female subjects.
Earlier single and multiple dose phase I studies showed that AD 337 is well tolerated with an attractive pharmacokinetic profile.
AD 337 exhibits comparable pharmacology to drugs that are showing promising results in fibromyalgia and has demonstrated antidepressant and anxiolytic activity. In addition, AD 337 is expected to have a low-incidence of drug-drug interaction. AD 337 is also being considered for use in other indications.
Currently there are no drugs specifically approved for fibromyalgia although some treatments are available to deal with various symptoms of the disease.
Sosei Group said that it expects the global market for the drug to grow to over $1 billion in the next 10 years.