Could You Benefit From A Libido Drug?

Image: CC BY-ND 2.0

Mayo Clinic News Network – A new drug for premenopausal women with low sexual desire has been approved by the FDA.

Vyleesi is designed to treat low libido in women, known as hypoactive sexual desire disorder.

This disorder is characterized by low sexual desire that’s not related to an other issue, such as a medical condition, relationship issues or lack of sex education. OUR VIEW: It’s not necessarily a ‘disorder’ (see below.) 

Dr. Stephanie Faubion, the Bill and Penny George Director of the Center for Women’s Health at Mayo Clinic, says there is one drug already on the market for low sexual desire. This drug, Addyi (flibanserin), works through different brain chemicals than bremelanotide injection.

“Flibanserin works on the serotonin and dopamine brain transmitters; whereas, bremelanotide is working on melanocortin,” says Dr. Faubion. “Both of these drugs are either working on increasing those brain chemicals that are excitatory or reducing the chemicals that are inhibitory.”

Dr. Faubion says this is not the female Viagra. “It’s sad that we continue to reference everything in terms of a male drug,” says Dr. Faubion. “Viagra affects blood flow. These drugs that are approved for sexual desire in women — both flibanserin and bremelanotide — affect the brain neurochemicals. They’re not about the arousal aspect.”

This new medication is given as an injection in either the abdomen or the thigh. “It’s a little different from the other drug, flibanserin, in that it is given by injection on demand,” says Dr. Faubion.

“That means it’s not used as a daily drug. It’s just used when the woman wants to have sex. She would inject the drug about 45 minutes before planned sexual activity and it lasts for a few hours.”

Watch Dr. Stephanie Faubion discusses the newest libido drug for women.

This latest libido drug is for a specific age group.

“A good candidate would be a premenopausal woman in whom we cannot identify any other treatable cause for low sexual desire — for example, another medication that’s causing a problem or sexual pain,” says Dr. Faubion.

She says that while the FDA has approved the drug for premenopausal women, it doesn’t mean it wouldn’t work for older women. But, she adds, more studies are needed for post menopausal women.

Low sexual desire remains the most common sexual problem in women of all ages, says Dr. Faubion. “About 44% of the female population reports some form of a sexual problem.”

“This is not the female Viagra. It’s sad that we continue to reference everything in terms of a male drug,” says Dr. Faubion.

There can be several causes for low sexual desire, including a medical condition such as heart disease or diabetes, or even hip arthritis. Dr. Faubion says hormonal changes associated with menopause also can cause difficulties with sexual desire. And there’s a psychological category.

“Women with anxiety and depression often have difficulty with sexual functioning,” says Dr. Faubion. “It might also be because some women don’t feel good about their body and have a poor body self-image, or perhaps related to a history of substance abuse, sexual abuse, or emotional or verbal abuse.”

There’s even a sociocultural category to consider. “That means how much sex education did a patient have,” says Dr. Faubion. Questions about what society and religion teach about sex are also important to explore, as well as the relationship category, partner communication and whether a partner might have sexual dysfunction.

There are some side effects to consider for patients. In studies leading up to the FDA approval, about 40% of women had some nausea, and about 20% of women experienced some flushing, according to Dr. Faubion.

Vyleesi is expected to be available for health care providers to prescribe in September.

# # #

OUR VIEW

“Low libido” is not a disorder 

Headline Health – Some people are shorter than average. Some have less pigment than others. Or less hair.

Are these things necessarily disorders? In some cases, perhaps – dwarfism is a genetic disorder that causes adults to have short stature. Hair loss, too, can be caused by a disease.

But not all differences, even differences we don’t like, are disorders.

It is in fact perfectly natural for a person’s seix drive to diminish along with age-related reduction in hormones.

A new drug, Vyleesi, is designed to “affect the brain neurochemicals” of women seeking treattment for dimished sexual desire. Vyleesi comes with the following warnings:

VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.

WARNINGS AND PRECAUTIONS
Transient Increase in Blood Pressure and Decrease in Heart Rate: VYLEESI transiently increases blood pressure and reduces heart rate after each dose. Advise patients that these changes usually resolve within 12 hours. VYLEESI is not recommended in patients at high risk for cardiovascular disease. Consider the patient’s cardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. To minimize the risk of more pronounced blood pressure effects, patients should not take more than one VYLEESI dose within 24 hours. Patients should not use more than 8 VYLEESI doses per month.

Focal Hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Patients are at higher risk of developing focal hyperpigmentation if they have darker skin and with daily dosing. Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI. Consider discontinuing VYLEESI if hyperpigmentation develops.

Nausea: Reported by 40% of patients who received up to 8 monthly doses, requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Nausea improves for most patients with the second dose. Consider discontinuing VYLEESI or initiating anti-emetic therapy for persistent or severe nausea.

ADVERSE REACTIONS
Most common adverse reactions (incidence >4%) are nausea, flushing, injection site reactions, headache, and vomiting.

DRUG INTERACTIONS
VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction.

PREGNANCY
Advise patients to discontinue VYLEESI if pregnancy is suspected. Advise patients to use effective contraception while taking VYLEESI.

There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers are encouraged to call the VYLEESI Pregnancy Exposure Registry at 1-877-411-2510.

INDICATION
VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:

A co-existing medical or psychiatric condition,
Problems with the relationship, or
The effects of a medication or drug substance.
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.

Limitations of Use

VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men.
VYLEESI is not indicated to enhance sexual performance.

The last line is particularly telling: “VYLEESI is not indicated to enhance sexual performance.” So … what’s it for again?

For those looking to increase their level of sexual interest and activity without taking a prescription designed to “affect the brain neurochemicals,” Headline Health has published many practical suggestions, none of which come with a long list of “warnings and contraindictaions”