Trial Shows Positive Results for Treatment 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.”
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Phase 2 results show slightly better results than Cymbalta, the most effective of the three FDA-approved fibromyalgia drugs (Lyrica, Cymbalta, and Savella).
Side effects were low, with more patients from the placebo group dropping out of the trial due to adverse reactions than those taking IMC-1.
“The results of this study suggest that IMC-1 is safe and efficacious in the treatment of the symptoms of fibromyalgia. Based on a novel mechanism of action and the study results showing efficacy on a range of important outcome measures, improved retention rates, decreased adverse event rates, IMC-1 may represent an effective and differentiated treatment for fibromyalgia sufferers.”
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.