Overview
Female sexual dysfunction consists of four recognized disorders: decreased sexual desire, decreased sexual arousal, dyspareunia (painful sexual intercourse) and a persistent difficulty in achieving or inability to achieve orgasm (Anorgasmia). In a survey of over 1700 women aged 18 to 59, 43% acknowledged some form of sexual dysfunction. Looking further into the survey results, the data suggested that 32% of the women lacked interest in sex and 26% could not experience orgasm.(1)
At present, no pharmacologic therapies are approved by the FDA for the treatment of Female Sexual Dysfunction. Some treatments have been used off-label, including psychotropic medications and phosphodiesterase (PDE-5) inhibitors, with limited efficacy.
Testosterone is the primary circulating androgen in women and is a naturally occurring steroid secreted by the ovaries and the adrenal glands. Contrary to the sudden drop in estrogen during menopause, serum levels of androgens fall gradually as women age primarily due to a decrease in the production of adrenal androgen precursors. Testosterone plays a role in mood, body composition, bone mineral density and has central and peripheral effects on sexual function. Over the two past decades, over 80 studies have been conducted in women with female sexual dysfunction using exogenous testosterone through the oral, transdermal, sublingual or parental route of administration with or without concomitant estrogen therapy, resulting in an increase in sexual desire, arousal, frequency of satisfactory sexual activity, pleasure and responsiveness.
Tefina™ - Anorgasmia
The Corporation’s product candidate TefinaTM is an intranasal low-dose gel formulation of testosterone. TefinaTM is being developed to offer women experiencing anorgasmia – a “use as required” treatment option. Anorgasmia is defined as the persistent or recurrent delay in, or absence of, orgasm following normal sexual excitement phase that causes marked personal distress or interpersonal difficulties. The etiology of anorgasmia is often characterized by whether the dysfunction has been lifelong (primary) or acquired (secondary).
The “use as required” treatment regimen for TefinaTM is expected to present an attractive safety profile with virtually no androgen-related side effects such as acne, facial and body hair growth or deepening of the voice. Moreover, there is no expected risk of skin-to-skin transfer of testosterone to third parties with the multi-dose nasal dispenser.
Tefina™ has successfully completed an initial clinical trial in patients with both Hypoactive Sexual Desire Disorder and Anorgasmia. From a pharmacokinetic perspective the trial confirmed that testosterone could be delivered intranasally both safely and effectively and further generated physiological data with produced a very positive clinical response.
Tefina™ entered Phase II clinical trials in the first half of 2011.
Sources:
1) Lauman et al. Sexual dysfunction in the United States: prevalence and predictors. Journal of the American Medical Association. April 1999.