A combination of famciclovir and celecoxib may be an effective treatment for patients with fibromyalgia, according to recently presented data from a phase 2a study.
“A proprietary combination of famciclovir, which we postulate is inhibiting herpesvirus replication, and celecoxib, known to inhibit both herpesvirus replication and reactivation, was efficacious in treating multiple symptoms of fibromyalgia,” the researchers wrote.
A cohort of 143 patients with fibromyalgia who met American College of Rheumatology 2010 criteria were enrolled into a double-blind, placebo-controlled, 16-week study at 12 sites. Patients were randomized 1:1 to a combination of famciclovir and celecoxib or a placebo group.
At 16 weeks, a significant decrease in pain was reported by patients in the treatment group compared to patients in the placebo group. An absolute change of – 1.9 was observed on a numeric rating scale compared to – 1.1 in the placebo group. A change of – 2.2 was observed on the Fibromyalgia Impact Questionnaire-Revised (FIQ-R) compared to – 0.92 in the placebo group.
A value of 1 or 2 was considered a clinical response on the Patients' Global Impression of Change (PGIC) scale, which was observed in 33.3% of patients in the treatment group compared to 19.2% of patients who received placebo.
At the last visit, the total change in FIQ-R was – 17.54 in treated patients compared to – 7.87 in the placebo group. Function domain scores of the FIQ-R decreased by 14.29 in the treatment group compared to – 5.44 in the placebo group, the Overall impact domain decreased by – 4.29 in treated patients compared to – 1.89 in the placebo group and the Symptoms domain scores lowered by – 16.77 compared to a – 7.9-point decrease in the placebo group. Patient-Reported Outcomes Measurement Information System fatigue scores improved – 7.62 points in the treatment group compared to a – 4.15 reduction in the placebo arm.
Adverse events included nervous system and gastrointestinal symptoms, which were higher in the placebo group, and the completion rate was 82.6% in the treatment group compared to 60.8% in those who received placebo.
“Given the simultaneous improvement in many domains and the surprising tolerability of this combination of drugs, we believe this combination warrants further study as a potential new therapy for fibromyalgia patients,” the researchers concluded. – by Shirley Pulawski
Pridgen W, et al. Paper #1878. Presented at: American College of Rheumatology Annual Meeting; Nov. 7-11, 2015; San Francisco.
Disclosure: The researchers each report an affiliation with Innovative Med Concepts.