A famciclovir + celecoxib combination treatment is safe and efficacious in the treatment of fibromyalgia

Abstract

Objective

Infections and other stressors have been implicated in the development of fibromyalgia. We hypothesized that these stressors could result in recurrent reactivations of latent herpes virus infections, which could lead to the development of fibromyalgia. This study evaluated a famciclovir + celecoxib drug combination (IMC-1), active against suspected herpes virus reactivation and infection, for the treatment of fibromyalgia.

Methods

A total of 143 fibromyalgia patients were enrolled at 12 sites in a 16-week, double-blinded, placebo-controlled proof-of-concept trial. Randomized patients received either IMC-1 or placebo in a 1:1 ratio. Outcome measures included a 24-hour recall pain Numerical Rating Scale, the Revised Fibromyalgia Impact Questionnaire (FIQ-R), the Patient’s Global Impression of Change (PGIC) questionnaire, the Multidimensional Fatigue Inventory, the NIH Patient-Reported Outcomes Measurement Information System (PROMIS), and the Beck Depression Inventory-II conducted at baseline and weeks 6, 12, and 16 of the study.

Results

A significant decrease in fibromyalgia-related pain was observed for patients on IMC-1 treatment versus placebo. PGIC response rates were significantly improved with IMC-1 treatment. Overall, patient self-reported functioning, as measured by the FIQ-R, was significantly improved. Fatigue was also significantly improved as measured by the PROMIS fatigue inventory. The safety profile was encouraging. Despite the celecoxib component of IMC-1, gastrointestinal and nervous system treatment emergent adverse events were reported less frequently in the IMC-1 group, and study completion rates favored IMC-1 treatment.

Conclusion

IMC-1 was efficacious and safe in treating symptoms of fibromyalgia, supporting the hypothesis that herpes virus infections may contribute to this syndrome. Improved retention rates, decreased adverse event rates, and evidence of efficacy on a broad spectrum of outcome measures are suggestive that IMC-1 may represent an effective, novel treatment for fibromyalgia.

Keywords:

• fibromyalgia
• famciclovir
• celecoxib
• antiviral
• herpes virus

Acknowledgments

The authors thank the patients who participated in this clinical trial. We also wish to acknowledge the participating investigators: Christopher Alftine, MD (Sunstone Medical Research, LLC, Medford, OR), Lucinda Bateman, MD (Fatigue Consultation Clinic, Salt Lake City, UT), Ara Dikranian, MD (San Diego Arthritis Medical Clinic, San Diego, CA), Francisco Garcia, MD (Superior Research, LLC, Sacramento, CA), Mark Graves, MD (Deaconess Research Institute, Evansville, IN), Cynthia Huffman, MD (Meridien Research, Tampa, FL), John Lafata, MD (Progressive Clinical Research, Vista, CA), Michael Lockwood, MD (IU Health Arnett, Lafayette, IN), Steven Mathews, MD (Jacksonville Center for Clinical Research, Jacksonville, FL), Alicia Prestegaard, MD (Michigan Head-Pain & Neurological Institute, Ann Arbor, MI), John Rubino, MD (PMG Research of Raleigh, LLC, Raleigh, NC), and Hayes Williams, MD (Achieve Clinical Research, LLC, Birmingham, AL).

Disclosure

This study was funded by Innovative Med Concepts, LLC (IMC). William L Pridgen is the founder and CEO of IMC and is a shareholder in IMC. Carol Duffy received research support from IMC in the form of a Sponsored Research Agreement between the University of Alabama and IMC. Judy F Gendreau and R Michael Gendreau are paid consultants for IMC. The authors would like to disclose that this research was presented at the American College of Rheumatology 78th Annual Meeting/Association of Rheumatology Health Professionals 49th Annual Meeting November 14–19, 2014 Boston, MA. The authors report no other conflicts of interest in this work.