Editor’s note: Last May, National Pain Report ran an article by Donna Gregory Burch, about the pairing of famciclovir (Famvir), a common antiviral, with celecoxib (Celebrex), an anti-inflammatory arthritis drug, and it’s success in Phase 2 trials for the treatment of fibromyalgia. The combo, known as IMC-1, was billed as the next blockbuster fibromyalgia drug, with the potential to challenge the likes of Lyrica and Cymbalta, two of the most profitable drugs prescribed for fibromyalgia.
On March 7th, in a PR Newswire press release, Innovative Med Concepts announced that the Journal of Pain Research published the results of Phase 2 PRID-201 trial using IMC-1 for the treatment of fibromyalgia (Journal of Pain Research 2017:10 451-460).
The 16 week study was conducted at 12 research centers with 143 fibromyalgia patients.
According to the press release, “The PRID-201 study demonstrated that patients randomized to IMC-1 (celecoxib+famciclovir) experienced a significant decrease in fibromyalgia-related pain vs patients randomized to placebo. Over 50% of the IMC-1 patients had at least a 30% reduction of pain and 38% of them achieved at least a 50% reduction in pain during the study. Patient global impression of change (PGIC) and the revised disease specific fibromyalgia impact questionnaire (FIQ-R) response rates were also significantly improved. Additionally, IMC-1 significantly improved self-reported fatigue, as measured by the NIH developed PROMIS fatigue inventory. Essentially all primary endpoints and most of the secondary endpoints met statistical significance in the PRID201 Trial.”
The results of this Phase 2 trial are significant in that the FDA has granted IMC-1 fast track status, with IMC planning to start a Phase 3 study with an “improved IMC-1” this year.