New Non-opioid May Help Ease Sleep Problems

New Non-opioid May Help Ease Sleep Problems
A non-opioid therapy called ASP0819 failed to reduce fibromyalgia-associated pain over eight weeks, but showed promise as a safe treatment for sleep problems in a Phase 2a trial. The findings warrant further research into the therapeutic potential of ASP0819 for fibromyalgia, researchers said. The study, “Efficacy and Safety of ASP0819 in Patients with Fibromyalgia: Results of a Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial,” was published in the Journal of Pain Research. Treatments currently available to manage fibromyalgia symptoms are unable to fully alleviate the pain associated with the disorder. While opioids are used to treat many chronic pain disorders, they have not shown efficacy in easing fibromyalgia symptoms and carry risks of side effects and addiction. ASP0819, an experimental therapy developed by Astellas Pharma to treat pain in fibromyalgia, acts by targeting a calcium-activated potassium channel known as KCa3.1 that reduces the activity of pain-associated nerves. After positive results in healthy individuals, an Astellas-sponsored Phase 2a trial (NCT03056690) was conducted to assess the efficacy of ASP0819 as an analgesic as well as its safety and tolerability in patients with fibromyalgia.  A total of 184 participants (96.2% women and 82.1% white), mean age 49.3, received either a 15 mg oral dose of ASP0819 or a placebo once daily in the morning for eight weeks. Participants and researchers did not know who received the treatment or the placebo. Participants had a pain score of at least 4 on the Fibromyalgia Impact Questionnaire Revised (FIQR) scale from 1 to 10, where 10 is the most severe. Held at 24 sites across the U.S., the study had a screening period of up to six weeks, an eight-week treatment
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