Kalypsys will conduct a double-blind, placebo-controlled trial, which will enroll approximately 50 patients at 12-15 centers in the US, to demonstrate proof-of-concept for KD7040 as a treatment for neuropathic pain. Trial participants, who have had PHN-related pain of moderate-to-severe intensity for at least three months, will receive KD7040 or placebo for a period of 14 days. The endpoints of the trial include assessment of changes in worst and average daily pain scores, as well as impact on sleep, mood and function.
August Watanabe, vice chairman of Kalypsys, said: “While our initial focus is on the investigation of the therapeutic effects of the topical gel on PHN, we believe that KD7040 has potential in other indications. Therefore, KD7040 has a profile that fits nicely into a franchise focused on underserved chronic pain markets.”