Trimel Pharmaceuticals Corp. reported its testosterone nasal gel, Tefina, for the treatment of female orgasmic disorder (FOD), led to an increase in the average number of orgasms. Currently, there are no Food and Drug Administration-approved treatment options for FOD, which is characterized by an absence, delay, or reduced intensity of orgasm. During the clinical trial, 0.6 mg of Tefina led to a statistically significant increase in the average number of orgasms among pre- and post-menopausal women in the U.S., Canada, and Australia. None of the women reported serious side effects.

“Female Orgasmic Disorder is the second most prevalent sexual disorder affecting women,” said Dr. Sheryl Kingsberg, the U.S. principal investigator for the clinical trial and professor of reproductive biology and psychiatry at Case Western Reserve University in Cleveland, Ohio. “Approximately one in five women report difficulty with orgasm and one quarter of these show marked distress, a key criterion in a clinical diagnosis.”

The Toronto-based company stated it will advance Tefina toward commercialization, which would include FDA approval. The company is actively developing medications for male hypogonadism, female sexual dysfunction, and various respiratory disorders.

The Tefina study enrolled 253 participants who were randomly placed in one of four groups — three separate dosage strengths or placebo — and treated over the course of 84 days. Although the researchers primarily compared the number of orgasms, they also measured levels of distress, sexual functioning, and sexual event satisfaction. Improvement was achieved in all of these secondary goals.

Tefina is a “use-as-required” nasal testosterone gel with no androgen-related side effects, such as facial and body hair growth, deepening of the voice, or acne. By virtue of the nasal dispenser, it is expected that there will be no risk of skin-to-skin transfer of testosterone to third parties.

Pink Viagra

Another experimental drug, Sprout Pharmaceuticals's Flibanserin (commonly referred to as “pink Viagra”) is also seeking FDA approval in the area of female sexual dysfunction. Flibanserin is intended to relieve hypoactive sexual desire disorder or distressing low desire — the most common form of female sexual dysfunction.

Flibanserin is a non-hormonal drug that is believed to work on key neurotransmitters, or chemicals, in the brain that affect sexual desire. The researchers believe that flibanserin increases dopamine and norepinephrine (both responsible for sexual excitement) while decreasing serotonin (responsible for sexual inhibition). “There are 25 approved drugs for some form of male sexual dysfunction, but still a great big zero for the most common form of FSD [female sexual dysfunction],” Cindy Whitehead, the founder and COO of Sprout, recently told ABC News.