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Axsome Therapeutics Receives New U.S. Patent Covering AXS-02 for the Treatment of Complex Regional Pain Syndrome; Provides Patent Protection for AXS-02 into 2033 and Covers Uses of Oral Zoledronic Acid for Complex Regional Pain Syndrome

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Additional Relevant Details Axsome Therapeutics received a new patent (U.S. Patent No. 9,283,239), titled “Compositions for Oral Administration of Zoledronic Acid or Related Compounds for Treating Complex Regional Pain Syndrome”, from the U.S. Patent and Trademark Office. The patent provides intellectual property protection for AXS-02 (disodium zoledronate tetrahydrate), which is currently in development for the treatment of complex regional pain syndrome (CRPS).The patented claims cover uses of oral zoledronic acid, the active moiety in AXS-02, for the treatment of CRPS. Another patent covering uses of oral zoledronic acid for the treatment of CRPS (U.S. Patent No. 9,216,168) was issued in December 2015 and provides additional protection. The terms of these issued patents extend into 2033 and 2034, respectively. These patents are part of a portfolio of 19 issued patents covering AXS-02, other bisphosphonates or other osteoclast inhibitors. AXS-02 is a potent osteoclast inhibitor developed by Axsome as an oral, targeted, non-opioid, potentially first-in-class therapeutic for chronic pain, including pain associated with CRPS.CRPS is a debilitating condition characterized by severe, continuous, burning or throbbing pain in a limb. The excessive pain is accompanied by changes in skin color, temperature and/or swelling. It is considered to be one of the most painful conditions, results in loss of physical function, and can lead to significant and sometimes permanent disability. There is currently no medication approved for the treatment of CRPS.Axsome is currently conducting a Phase 3 trial, named the CREATE-1 study, of AXS-02 in patients with CRPS. This global trial is enrolling patients in the United States, the United Kingdom, Australia and Canada. AXS-02 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of pain associated with CRPS. AXS-02 has also been granted Orphan Drug Designation by the FDA and Orphan Medicinal Product Designation by the European Medicines Association (EMA) for the treatment of CRPS.
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Mar 15, 2016
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Related Keywords Axs-02, Complex Regional Pain Syndrome, Oral Zoledronic Acid, Disodium Zoledronate Tetrahydrate, Create-1 Study, Crps, Limb Pain, Osteoclast Inhibitor, Chronic Pain, Bisphosphonates, Complex Regional Pain Syndrome