POS0017 IMC-1, A FIXED DOSE COMBINATION OF FAMCICLOVIR AND CELECOXIB, IMPROVES COMMON SYMPTOMS ASSOCIATED WITH FIBROMYALGIA IN ADDITION TO PAIN: POST HOC ANALYSIS OF A PHASE 2A TRIAL

Abstract

Background: Fibromyalgia is a chronic disease characterized by widespread pain and severe fatigue that may be triggered by reactivation of latent herpes simplex virus type 1 (HSV‐1). In a Phase 2a proof of concept trial, IMC‐1 (a fixed dose combination of famciclovir and celecoxib) demonstrated greater tolerability and statistically significant reduction in pain compared with placebo, as measured by change from baseline to week 16 in 24‐hour recall pain intensity on an 11‐point Numerical Rating Scale (NRS) and 7‐day recall pain intensity on the 11‐point pain item on the Revised Fibromyalgia Impact Questionnaire (FIQ‐R). Objectives: In this post hoc analysis, we evaluated the effects of IMC‐1 compared with placebo on other fibromyalgia symptoms, including lack of energy, stiffness, problems with sleep, problems with memory, depression, and anxiety. Methods: In the double‐blind, multi‐center, placebo‐controlled trial, male or female patients 18‐70 years of age who met diagnostic criteria for fibromyalgia and had at baseline a 24‐hour recall average pain intensity score between 4 and 9 on the NRS were randomized 1:1 to 16 weeks of treatment with IMC‐1 or placebo. Mean changes from baseline to week 16 in FIQ‐R symptom scores were analyzed using a Mixed‐Effect Model Repeated Measure (MMRM) model with treatment as the main effect, and investigative site and baseline FIQ‐R symptom scores as covariates. Results: A total of 143 patients were enrolled and randomized to treatment with IMC‐1 (n=69) or placebo (n=74). Baseline demographic and clinical characteristics were comparable between treatment groups; the majority of patients were Caucasian (95.8%) and female (93.7%) with a mean age of ∼49 years. Compared with placebo, treatment with IMC‐1 resulted in statistically significant improvements in the FIQ‐R symptom scores of stiffness (least squares mean change from baseline ‐0.96 vs. ‐1.92, P=0.03), sleep quality (‐0.76 vs. ‐1.76, P=0.039), depression (‐0.44 vs. ‐1.33, P=0.016), and anxiety (‐0.30 vs. ‐1.69, P<0.001), but not in energy level (‐0.67 vs. ‐1.29, P=0.115) or memory problems (‐0.71 vs. ‐1.24, P=0.165). Conclusion: In addition to alleviation of chronic pain, treatment with IMC‐1 appears to be effective in improving many of the other symptoms often associated with fibromyalgia. Further clinical trials are warranted.