Taking Back the Taboo

Bringing attention to female sexual dysfunction issues

Finding a Solution to FSAID

With television commercials featuring beautiful women and seaside bathtubs, male sexual dysfunction gets a lot of attention in the pharmaceutical world. Just as big a problem, but much more taboo a topic, female sexual dysfunction lacks the solutions and drugs of the male market.

Just as big a problem, but much more taboo a topic, female sexual dysfunction lacks the solutions and drugs of the male market.

Thanks to the incredible marketing of Pfizer, male impotence was rebranded as erectile dysfunction (ED). Since the 1990s, numerous drugs have hit the market to solve it, including front-runners Viagra® and Cialis® and others like Staxin®, Levitra®, Stendra®, and Zydena®. All these PDE-5 inhibitors treat ED caused by compromised blood flow to the penis, a major cause of impotency issues in men.

Female sexual disorder, on the other hand, is more complicated with several different causes. It may be lifelong or acquired, the result of environmental and cultural factors, or situational. A woman’s sexual responsiveness has multiple variables, such as, age, estrogen status, testosterone status, making it hard to pinpoint an exact cause. Medications commonly used by women such as oral contraceptives and antidepressants can also be a factor.

Female Sexual Interest/Arousal Disorder (FSAID) has four components:
Desire/libido disorders – decreased or absence of sexual desire/libido
Arousal disorders – decreased or absence of sexual arousal
Orgasmic disorders – difficulty achieving orgasm, and/or anorgasmia (complete lack of orgasm)
Sexual pain disorders – dyspareunia, painful intercourse

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York City, said in an Associated Press article, “It’s a fairly complicated area. Unlike in men’s sexual dysfunction where there is a major mechanical concern, in women there’s no mechanical concern, so if she’s not having a successful sex life, where is the problem?”

Lots of Research, Little Progress

In 2000, the FDA published the Guidance for Industry on the clinical development of drug products for treatment of FSIAD. Since then, numerous pharmaceutical companies have expended hundreds of millions of dollars in search for an FDA-approvable drug to treat FSIAD.

Flibanserin, sold under the name Addyi, was approved in 2015 for the treatment of pre-menopausal women with FSIAD. Before then, only two New Drug Applications for Female Sexual Dysfunction had been submitted to, accepted by, and evaluated by the FDA. Both drugs were denied approval because of safety concerns.

Finding a solution for FSIAD has been an uphill battle with few answers. Fortunately, Callitas is working on the development of a new product, Extrinsa®, that may offer a solution.

Created to address the lack of female sexual dysfunction solutions, Extrinsa® focuses on women with orgasm and arousal difficulties. The topical, local, and non-systemic product is also non-hormonal and does not affect the central nervous system. It’s safe, natural, and effective and addresses a major need for a FSIAD product.