Innovative Med Concepts announced that the Food and Drug Administration (FDA) has granted Fast Track designation to IMC-1 for the treatment of fibromyalgia.
IMC-1 has successfully completed a randomized, double-blind, placebo-controlled Phase 2 study (PRID-201) in patients with fibromyalgia. The study was designed to confirm the hypothesis that latent herpes virus may have a role in fibromyalgia symptoms or recurrence. Suppression of chronic tissue-resident herpes virus, the mechanism of action of IMC-1, may significantly improve fibromyalgia-related symptoms.
The Phase 2 study showed promising data for IMC-1 in the treatment of pain and other symptoms associated with fibromyalgia. The company is currently working with the FDA to meet all the necessary requirements for the initiation of Phase 3 trials for IMC-1 in fibromyalgia.
IMC-1 is a fixed-dose combination of famciclovir, an antiviral nucleoside analog, and celecoxib, a COX-2 inhibitor.
For more information visit Innovativemedconcepts.com.