FDA Approves “ADDYI”

fda approved addyi todayDear Patient, Supporters and Friends,

Today the FDA made #HERstory for women with the approval of a first-ever medical treatment option for women’s most common sexual dysfunction, known as Hypoactive Sexual Desire Disorder, or HSDD. You can think of this disorder (HSDD) as: distressing low desire that can affect a woman, her partner or both and that lasts and lasts and lasts for more than 6 months regardless of circumstances, mood, vacation, health, etc. After enjoying normal sexual function, and then totally losing one’s interest in or desire for sex for longer than 6 months gives you some idea of the scope and impact of HSDD.

I know all of you have been closely monitoring the national conversation over the “little pink pill” or the “female Viagra” during the last year as the drumbeat has built among organizations such as ours – and among hundreds of thousands of people across the country – for treatment options for a condition that the FDA itself has recognized as a key unmet medical need. We at James A. Simon, MD, PC have been actively involved in the development of Flibanserin, or its new trade name ADDYI, for many years and have conducted several of the clinical trials used for FDA approval right here in the Washington, DC, office. For those of you who participated in those clinical studies, we want to personally thank you. Whether you received the active treatment in those trials or the matching placebo, soon you will be able to take “the real thing.”

James A. Simon, MD, PC is proud to be a part of such a thrilling moment in women’s sexual health and for the 16 million American women currently living without a single FDA-approved medical treatment option for HSDD.

With the FDA’s action today, The Agency not only approved a first-ever medical treatment option for HSDD, it also demonstrated that there IS a viable regulatory pathway forward toward approval of additional therapies for this and other female sexual health indications. Further, Flibanserin’s (ADDYI’s) approval today, opens the pipeline for other future options yet to come for women’s sexual health. In that vein, we are currently conducting additional studies on other medications for female sexual dysfunction right here at James A. Simon, MD, PC, and we are always looking for qualified study subjects/volunteers.

Women with HSDD deserve the safety and peace of mind that comes with access to FDA-approved medical treatment options, and today we write a new chapter in the fight for equity in sexual health.

Sincerely,
The entire James A. Simon, MD, PC family

 

Interested in women’s sexual health? Contact us for an appointment.

Contributed by

James A. Simon

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