therapeutic testosterone gel for treating chronic pain, chronic inflammatory pain, inflammation, chronic fatigue syndrome, and post traumatic st

White Mountain Pharma

Developing chronic pain treatments with therapeutic testosterone gel.

Innovations in Chronic Pain Therapeutics

Relief from fibromyalgia pain using White Mountain Pharma's therapeutic testosterone gel

Fibromyalgia

What is fibromyalgia:

Patients with fibromyalgia complain of chronic unresolvable widespread muscle pain. Common complaints include loss of feelings of well-being, having flu-like muscle aches but without the fever, “feeling like you have been hit by a Mack truck”, having difficulty getting out of bed in the morning, and having difficulty exercising.

Patient population:

Fibromyalgia affects 5 million people in the U.S. and is characterized by chronic muscle pain and fatigue. Patients with fibromyalgia have been shown to have significantly lower testosterone than age-matched controls. 90% of fibromyalgia patients are women, although the incidence in men may be under-reported. Currently, there is no FDA-approved testosterone replacement therapy for women.

Diagnosis of fibromyalgia:

  • Chronic, widespread pain (both above and below the waist, and on the left and right sides) upon digital palpation of at least 11 of 18 tender points (American College of Rheumatology, Wolfe 1990). Or a Widespread Pain Index (WPI) ≥7 and symptom severity (SS) scale score ≥5; or WPI 3-6 and SS scale score ≥9 (American College of Rheumatology,Wolfe 2010).
  • Pain symptoms have been present for at least 3 months.
  • The patient does not have a pain disorder that would otherwise explain the pain.
  • The American College of Rheumatology (ACR) fibromyalgia Classification Criteria are used for diagnosis and clinical studies. For additional information on diagnosis and treatment go to: (Wolfe 1990) (Wolfe 2010) (Clauw 2014).

Unmet needs of fibromyalgia patients:

Current therapeutics for the chronic pain of fibromyalgia are suboptimal and have significant unwanted side effects. A recent study has shown high economic costs of fibromyalgia patients: 83% had outpatient hospital visits in any single year, an average of 58 workdays were missed, and 30% received disability income (Robinson, Pain Medicine 2012).

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