Innovations in Chronic Pain Therapeutics
Patients with fibromyalgia have been shown to have significantly lower testosterone blood levels than age-matched controls. Currently, there is no FDA-approved testosterone replacement therapy for women. In contrast, initial studies support White Mountain Pharma’s novel hypothesis that a patented testosterone gel therapeutic has the potential to manage muscle pain, stiffness, fatigue and libido, while maintaining a beneficial safety profile with respect to serum testosterone levels and clinical symptoms, and without the adverse events seen in other fibromyalgia therapeutics.
Phase I/II clinical trial/study results using White Mountain Pharma’s testosterone gel therapeutic are now in press: “Treatment of pain in fibromyalgia patients with testosterone gel: Pharmacokinetics and clinical response”, White, H.D. et al, International Immunopharmacology, 2015. A Phase II trial is planned.
The goal of our planned phase II clinical trial is to confirm and extend our previous studies in which White Mountain Pharma’s testosterone gel therapy decreased chronic pain in fibromyalgia patients. At a formal pre-Investigational New Drug Application (IND) meeting, the FDA accepted White Mountain Pharma’s plans for this phase II study.
Fibromyalgia does not have the hallmarks of peripheral inflammatory pain conditions, such as high white blood cell counts or local swelling, redness and soreness. Rather, fibromyalgia patients have normal white blood cell counts, a normal erythrocyte sedimentation rate (which is elevated for chronic inflammatory pain states in the clinic) and a lack of localized swelling or inflamed joints. These patients do have high levels of the neuropeptide Substance P within the CNS in cerebrospinal fluid (Russell et al 1994) but not plasma, and abnormally low pain thresholds (Gracely et al 2002). White Mountain Pharma’s clinical trial data support our hypothesis that fibromyalgia patients have an inflamed nociceptive nervous system in which these pain fibers have augmented pain responses due to abnormally low testosterone levels, and further, that testosterone gel therapy can dampen the chronic pain in these individuals. The foundation for this hypothesis is summarized in White et al.
Consistent with this approach, a recent combined oral contraceptive pill (COCP) study of women with chronic pain conditions showed that pain processing as observed by brain imaging was significantly diminished in a subset of women with the lowest serum testosterone levels, and their pain threshold was low, as well, compared with the subset of women in the highest-T stratum (Vincent et al, Pain 2013). These findings support White Mountain Pharma’s approach, that testosterone therapy can reduce pain symptoms in patients with chronic pain.
MedlinePlus information on Fibromyalgia