Educational guide
Vyleesi for HSDD: Treatment for Low Sex Drive in Women
You may have heard about Vyleesi (bremelanotide), a medicine approved by the FDA to treat low sex drive, called hypoactive sexual desire disorder (HSDD), in premenopausal women. HSDD is the most common cause of sexual dysfunction in women. Women with HSDD stru
This guide cannot diagnose a condition or recommend a personal treatment plan. Discuss medical questions with a qualified professional.
You may have heard about Vyleesi (bremelanotide), a medicine approved by the FDA to treat low sex drive, called hypoactive sexual desire disorder (HSDD), in premenopausal women.
HSDD is the most common cause of sexual dysfunction in women. Women with HSDD struggle with an ongoing lack of interest in sex that also causes distress and problems with relationships. It is typically reported in women who previously had normal sexual desire and have experienced symptoms for more than six months, causing distress over 75% of the time.
Common symptoms of HSDD may include:
- Low or no libido (sex drive)
- No sexual fantasies or thoughts
- Distress at the thought of having sex
- Loss of interest during sexual activity
- Avoiding sex or activities that could lead to sex
- Less or no pleasure or orgasms during sex most of the time
Below are some common questions and answers about Vyleesi for HSDD and whether it may be an option for you.
How Does Vyleesi Work for Low Sex Drive?
Vyleesi contains the active ingredient bremelanotide. It belongs to a class of medicines called melanocortin receptor agonists. Vyleesi is thought to turn on the melanocortin receptors to balance certain chemicals, such as serotonin, dopamine, and norepinephrine. These chemicals are important for normal sexual health and sexual desire. Serotonin in excess can lower the effects of dopamine and norepinephrine, leading to decreased sexual desire. Vyleesi may balance the level of serotonin in your brain, lowering the inhibition of sexual thoughts or feelings. Dopamine and norepinephrine are associated with the reward, pleasure, and excitement seen with normal sexual desire. Dopamine is associated with pleasure and reward pathways in the brain, with feelings of attraction, excitement, and motivation to initiate or respond to sexual contact. Norepinephrine is associated with excitement, energy, and focus due to sexual cues. Vyleesi may boost the levels of dopamine and norepinephrine, leading to increased sexual desire. While Vyleesi helps manage the symptoms of HDSS, it does not cure the disorder.
Is Vyleesi Right for Me?
Vyleesi may be right for you if you are premenopausal and have an ongoing lack of interest in sex that causes distress or problems with your relationships. Vyleesi should not be used by men or postmenopausal women. It should also not be used to improve sexual performance or for low sexual drive caused by medical or mental health problems, relationship problems, or another medicine. Your health care provider may give you a screening tool to help talk about your symptoms. They can also help determine if Vyleesi may be right for you.
How Was Vyleesi Studied for HSDD?
The FDA approved Vyleesi for HSDD based on two studies that showed how well it works and how safe it is to use. These studies were called RECONNECT. The combined studies included more than 1,200 adult women with diagnosed HSDD. People in the studies had the following traits:
- Everyone reported a low sex drive that caused distress or problems in their relationship.
- All women were premenopausal, meaning they had not gone through menopause, and were in a stable, long-term relationship with a partner who was willing to be sexually active.
- Most of the women were in their mid-30s to early 40s, had been struggling with low desire for at least six months, and reported having had normal sexual desire previously.
- Most women had low sexual desire scores and high distress scores, based on the screening completed at the beginning of the studies. These questionnaires included: Female Sexual Function Index-Desire Domain (FSFI-D) Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DOA)
- Female Sexual Function Index-Desire Domain (FSFI-D)
- Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DOA)
Women could not join the studies if they had certain medical conditions or mental health problems or if they took certain medicines, such as antidepressants or sleep aids.
Everyone was randomly assigned to use Vyleesi injection or a placebo (a fake treatment with no medicine) about 45 minutes before sexual activity. But no one knew if they were using an injection with medicine or the placebo. People did not use more than one dose in 24 hours or more than eight doses in a month.
In both studies, the effect of Vyleesi was measured by measuring changes in sexual desire and distress scores. A response was defined as:
- An increase in the “desire” score from the FSFI-D questionnaire, where a higher score means better desire
- A decrease in the “distress” score from the FSDS-DOA questionnaire, where a lower score means less distress
What Benefits of Vyleesi Were Seen in Studies?
After 24 weeks, women using Vyleesi before sexual activity felt some improvement in their sexual desire and were less distressed about it, compared to people using the placebo. The table below summarizes the percentages of women who had changes in their “desire” and “distress” scores. Those using Vyleesi saw a bigger increase in the “desire” scores than those using the placebo. Also, women reported being less distressed by their low desire than those using the placebo. Changes in Desire and Distress Scores from RECONNECT
The study showed meaningful results for many of the premenopausal women, while some saw less improvement. Keep in mind that your results may differ from study results.
How Do I Use Vyleesi?
Vyleesi is an injection that you give under the skin (subcutaneously), in your thighs or stomach area (abdomen). Inject Vyleesi at least 45 minutes before sexual activity. Do not use more than one dose within 24 hours or more than 8 doses within a month. Choose a place on your stomach area (at least 2 inches away from your belly button) or the front of your thigh to give the injection. Make sure to choose a different place for each injection. Read and follow the instructions that come with the medicine. Do not use Vyleesi unless you have received training from your health care provider or pharmacist. After the injection is complete, do not cap the injector. Place the entire injector into a container that is safe for used “sharps” equipment. Do not throw the injector away in your household trash or recycling bin. Talk to your health care provider or pharmacist if you have questions about safe ways to throw away (dispose) the injector.
How Can I Tell if Vyleesi Is Working?
It may take several uses of Vyleesi before you see changes in your sexual desire or the distress you feel about your low desire. You can tell that the medicine is working if you notice more interest in sex or sexual activities, or if you feel less bothered by your low desire. These changes may be small and may happen slowly over time.
- More interest in sex may include: Thinking about sex more often or more easily Feeling more open to sex when a partner shows interest Feeling more “alive” with romantic or erotic cues
- Thinking about sex more often or more easily
- Feeling more open to sex when a partner shows interest
- Feeling more “alive” with romantic or erotic cues
- Less emotional distress may include: Feeling less guilt, frustration, or sadness about not wanting sex Fewer issues with your partner about sex
- Feeling less guilt, frustration, or sadness about not wanting sex
- Fewer issues with your partner about sex
If you feel that Vyleesi is not working after eight weeks, talk to your health care provider for advice.
How Can I Get Vyleesi?
Vyleesi requires a prescription from a health care provider. They will send the prescription directly to a specialty pharmacy. This pharmacy will work with you, your provider, and your insurance to fill the prescription. You cannot get this medicine at your local pharmacy. This medicine will be mailed to your home.
Is There Any Cost Assistance Available for Vyleesi?
The cost of Vyleesi can vary depending on your insurance status. Some insurance plans may cover this medicine, while some may not. Financial assistance may be available. The pharmacy will work with you and your insurance to check if there is a savings program that can lower the cost if you qualify. You can visit this website for more information.