Wednesday, November 25, 2020

Sex disorder, female solution

Last weekend, a new pill became available to help women across the country increase their sexual libidos.

Manufactured by Sprout Pharmaceuticals, flibanserin (brand name Addyi) was given the green light by the federal drug agency in August for the treatment of hypoactive sexual desire disorder, or HSDD — a condition characterized by low sexual desire.

HSDD is defined as “persistent absence of sexual thoughts, fantasies, responsiveness and willingness to engage in sexual activity that causes personal or relationship distress and cannot be accounted for by another medical condition or substance,” according to Sprout Pharmaceuticals’ press release on Addyi.

Society for Women’s Health Research, a national non-profit organization based in Washington D.C., said HSDD is the most common female sexual dysfunction and affects about 1-in-10 women.

The Mayo Clinic, a nonprofit medical practice and medical research group, notes that as many as 40 percent of women have HSDD at some point in their lives while 5 to 15 percent of women have the problem continuously.

Sprout Pharmaceuticals believes Addyi will correct an imbalance in brain chemicals that are responsible for sexual desire.

The studies by Sprout Pharmaceuticals were done by having women take one pill a day for a month. The clinical trials showed that, on average, women on Addyi increased their number of satisfying sexual events by one a month from a baseline of two or three. That’s not an enormous amount, but there is a subset of women for whom the drug had a better effect and, for them, the drug may prove to be of value. It was these data that led the FDA to approve Addyi.

However, similar to other drugs, it comes with risks — in this case dizziness, low blood pressure, fainting and sleepiness.

These risks are increased and become more severe when patients drink alcohol or take Addyi with certain medicines that interfere with the breakdown of Addyi in the body. Because of the chemical interaction, the use of alcohol is counter-active while taking the drug. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

“It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition,” Cindy Whitehead, chief executive officer of Sprout, said in a press release said. “We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence.”

Following the FDA approval, Medscape.com, a part of WebMD Health Professional Network, talked to Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” Woodcock said. “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

But before women go to their doctors and ask for Addyi, Plattsburgh State Student Health and Counseling Center Director Kathleen Camelo said more evaluations should be done first.

“We don’t want to give someone a pill and say ‘go try this,’” Camelo said. “If a more in depth evaluation of a woman happens, the woman’s problem can be fixed without the use of the pill.”

Camelo said the doctor should do a detailed history of the patient. Getting a physical exam can also let the doctor see if there is a physical issue that is affecting a woman’s libido.

“I do think it’s another tool,” Camelo said. “We really haven’t had a drug that helps the woman aspects of sex.”

Camelo said Addyi brings attention to a woman’s sexual drive. Sexual health, she said, is an important part of a woman’s full body health.

“It’s a part of daily life,” she said. “I hope women feel more comfortable now to go to their doctors and discuss this issue.”

Addyi is now available and is expected to cost between $30 and $75 a month for women with medical insurance, according to Sprout Pharmaceuticals. The company will use 200 sales representatives to detail clinicians already familiar with diagnosing HSDD — primarily obstetricians and gynecologists. Some psychiatrists and primary care physicians will also be included.

Email Samanatha Stahl at samantha.stahl@cardinalpointsonline.com

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