You are here
New Fibromyalgia Treatment Shows Promise in Mid-Stage Study
An investigational oral medication known as IMC-1 (Innovative Med Concepts) –– a fixed-dose combination of famciclovir and celecoxib –– was shown to be effective at reducing pain and other symptoms of fibromyalgia in a recent randomized, double-blinded, placebo-controlled, phase II study.
The results were presented November 18 at the 2014 American College of Rheumatology annual meeting in Boston.
Fibromyalgia is a multi-symptom disorder involving widespread pain, fatigue, headaches, sleep problems, mood changes, and the inability to concentrate. Its cause is unknown. According to the National Fibromyalgia Association, an estimated 3% to 6% of people worldwide have the condition —10 million people in the U.S. alone.
The 16-week study evaluated the efficacy and safety of IMC-1 in 143 fibromyalgia patients at 12 U.S. clinics. The patients received either IMC-1 or placebo.
It has been theorized that chronic tissue-resident herpes virus may be an underlying cause of fibromyalgia. IMC-1 represents a novel treatment approach by combining an anti-herpes virus nucleoside analog (famciclovir) with the anti-herpes virus activity exhibited by the cyclooxygenase-2 (COX-2) inhibitor celecoxib.
Patients rated their pain over the course of the study using a 0-to-10 numeric rating scale, with the study’s primary endpoint being the reduction in average pain from baseline to week 16. Pain measured on both a 24-hour and 7-day recall basis met statistical significance, with the 7-day recall data achieving high statistical significance (P = 0.001). Other therapeutic domains that showed statistical significance included the Patient Global Impression of Change (PGIC); all three Revised Fibromyalgia Impact Questionnaire (FIQ-R) domains; 30% and 50% pain-reduction responder analysis; and the NIH PROMIS fatigue instrument.
The study also showed a lower discontinuation rate among patients in the IMC-1 arm compared with those in the placebo arm, with 82.6% of patients treated with IMC-1 completing the full 16 weeks of therapy compared with 60.8% of patients given placebo. The discontinuation rate due to adverse events was almost three times lower for patients in the IMC-1 group than for those in the placebo group (5.8% vs. 16.2%, respectively; P = 0.012). While 41% of patients receiving placebo used rescue medication, only 25% of those in the IMC-1 group required such medication (P = 0.037).
Source: PR Newswire; November 18, 2014.