Axsome Therapeutics, Inc., a biopharmaceutical company dedicated to developing therapies for the treatment of pain and other central nervous system disorders, announced last month that the first patient has been enrolled in the CREATE-1 (CRPS Treatment Evaluation 1) study, a Phase 3 trial evaluating the effectiveness and safety of disodium zoledronate (AXS-02) in the treatment of the pain associated with complex regional pain syndrome (CRPS), also known as reflex sympathetic dystrophy (RSD).
The CREATE-1 study is expected to enroll 190 patients at sites in the U.S., Canada, Europe, and Australia. Eligible patients will be treated with either AXS-02 or a placebo, and the primary objective will be to measure the change in patient-reported pain intensity, measured with the Numerical Rating Scale.
FDA Fast Tracks AXS-02
In March 2015, the U.S. Food and Drug Administration (FDA) granted “Fast Track” designation to AXS-02 for the treatment of the pain associated with CRPS/RSD. AXS-02 is an osteoclast inhibitor being developed as an oral, non-opiod medication to treat the chronic pain. It is an investigational medication not yet approved by the FDA, and its safety and efficacy have not yet been determined.
Fast Track designation typically expedites approval by providing greater access to and more frequent communication with the FDA throughout the drug development and review process. Fast Track designation also gives Axsome Therapeutics the opportunity to potentially submit sections of the AXS-02 new drug application on a rolling basis, allowing the medication to be considered for priority review at the time of submission.
About CRPS/RSD
CRPS/RSD is a debilitating condition characterized by severe and chronic pain in a limb, accompanied by autonomic, sensory, motor, and trophic changes. The pain and associated loss of function results in significant and sometimes permanent disability for many patients, and there is no non-opiod drug currently approved to treat CRPS/RSD in the U.S. or the European Union.
