While men’s sexual health has been a popular and lucrative industry for some time, women’s health finally has a new entry. Sprout Pharmaceuticals, Inc., a division of Valeant Pharmaceuticals North America LLC, announced Addyi to treat hypoactive sexual desire disorder (HSDD) in premenopausal women.
There’s no doubt that sex drugs for men have been a boon for the pharmaceutical industry. The FDA approved Viagra in 1998. Last year Viagra earned more than $1.6 billion for Pfizer and companies are hoping that they will be able to earn that with drugs that help women. But thus far drug companies have struggled to come up with the right formula.
The market is definitely there. According to research, female HSDD may occur in up to one-third of adult women in the US. The essential feature of female HSDD is a deficiency or absence of sexual fantasies and desire for sexual activity that causes marked distress or interpersonal difficulty. The evaluation of female HSDD generally requires careful and thoughtful consideration of the patient and the multitude of factors that impact on the various components of adult female sexual desire.
Several female reproductive life experiences may uniquely affect sexual desire. These events include menstrual cycles, hormonal contraceptives, postpartum states and lactation, oophorectomy and hysterectomy, and perimenopausal and postmenopausal states. Sexual dysfunctions in women have strong positive associations with low feelings of physical and emotional satisfaction and low feelings of happiness. Thus, female HSDD can greatly impact on quality of life. In this article, treatment options are discussed with special attention to significant reproductive life events that may impact on sexual desire in adult women. Depending on the particular phase of reproductive life that a woman is experiencing, different recommendations are made. Various options in the treatment of HSDD in women include lifestyle changes, treatment of coexisting medical or psychiatric disorders, switching or discontinuing medications that could impact on sexual desire, hormone therapy and marital therapy. In addition to Addyi, other clinical trials are presently underway to assess medications that may potentially benefit female patients with HSDD.
There are two types, both of which can be treated by the new drug. Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner. Addy is a once-daily, non-hormonal pill and is now available in the United States through certified physicians and pharmacies. Addyi was approved by the U.S. Food and Drug Administration (FDA) on August 18, 2015.
“Finally, all women who have been waiting for a medical treatment option can now make their own decision with their healthcare provider if Addyi is right for them,” said Sprout Pharmaceuticals Chief Executive Officer Cindy Whitehead. “With our availability nationwide today, we are proud of our affordable and innovative programs to offer Addyi for as little as $20 per prescription.”
Sprout will offer two avenues of affordable access for women, including the Addyi Affordable Access Card for pharmacies and the AddyiDirect program with doorstep delivery. For more information about both programs, you can visit www.Addyi.com or talk your healthcare provider.
“Acquired, generalized HSDD is the most common sexual complaint that I see among women in my practice, so having Addyi as an option for them is game changing. It’s my belief that Addyi marks a new era for women and couples to have an honest conversation about what’s happening for her in the bedroom. I think we’ll see the positive effects of this dialogue well beyond medicine,” said Dr. Karen Boyle, urologic surgeon at Chesapeake Urology Associates at Greater Baltimore Medical Center.
The approval of Addyi is largely based on three North American, Phase 3, 24-week, randomized double blind, placebo-controlled studies of premenopausal women with HSDD. Addyi was administered to over 2,500 premenopausal women with acquired, generalized HSDD in clinical trials, with over 850 receiving treatment for at least 12 months. For premenopausal women with HSDD, Addyi has demonstrated improvements in desire for sex, reducing distress from the loss of sexual desire and increasing the number of satisfying sexual events.
Addyi is not indicated for use in postmenopausal women or men or to enhance sexual function. Addyi was approved with a Boxed Warning.
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Lindsey McCoy MPA, is an Executive Medical Recruiter and former CEO in the not for profit sector.