AD337 achieves proof-of-concept in fibromyalgia trial

Japanese biopharmaceutical company Sosei says that its product candidate AD 337 has completed a Phase II proof-of-concept trial as a treatment for fibromyalgia syndrome. The drug, which is an enantiomer of an approved, centrally-acting, non-opioid analgesic, brought about a change in the Fibromyalgia Impact Questionnaire score of patients who received it for a period of four weeks, although not to a level of statistical significance.

In contrast, statistical significance in certain therapeutic efficacy measures was achieved at week one of the study, but such improvements changed into positive trends by the end of the program. Sosei concluded that AD337 has some potential in fibromyalgia, but added that it would fully review the findings before deciding how to develop the drug further.