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Meet Vyleesi.

Introducing the first and only FDA-approved as-needed treatment for premenopausal women with acquired, generalized HSDD.

First things first:
Vyleesi…

*yes*

  1. Increases sexual desire and reduces related distress

  2. Can be taken when you choose—letting YOU take control

  3. Should be taken at least 45 minutes before anticipated sexual activity

  4. Has no alcohol restriction

Do not take Vyleesi more than one time within 24 hours or more than 8 times per month. Vyleesi can cause serious side effects, including temporary increase in blood pressure and decrease in heart rate, darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast, and nausea.†

Do not use Vyleesi if you have:

  1. high blood pressure that is not controlled (uncontrolled hypertension)

  2. known heart (cardiovascular) disease

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

How does Vyleesi do this?

It’s been known for a long time that the brain is responsible for sexual desire.
Women who have HSDD have an imbalance of neurotransmitter (chemical messengers) activity in the brain, resulting in low sexual desire.

Vyleesi is believed to act on certain neurotransmitters, called melanocortins, to help improve sexual desire. The exact way that Vyleesi works isn’t fully known.

HSDD 101

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So…is it effective?

We’ll let the science do the talking.
The Vyleesi clinical studies included more than 1,200 premenopausal women with HSDD.†

Here’s what they found:

  1. Vyleesi increased sexual desire and reduced related distress

  2. Women who took Vyleesi experienced continued meaningful improvement of HSDD symptoms

  3. The most common side effects are nausea, flushing, injection site reactions, headache, and vomiting.

  4. Nearly 80% of women who completed the clinical study volunteered for an additional one-year extension.

Vyleesi can cause serious side effects, including temporary increase in blood pressure and decrease in heart rate, darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast, and nausea.†

Want to find out if Vyleesi is right for you?

The first step is to talk to a healthcare professional—you can do that online from your phone or computer.

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Let's hear from some women who participated in the clinical trials.

Some of the women who participated in the clinical trials volunteered to be interviewed about their experience.‡ Here are some of their responses:

  1. ...it did give me that increase and that boost...to go from not having any sex drive...to doing that and being close with my husband, I would say it definitely worked for me and—and was much better.

  2. …I hadn’t felt [the desire] in so long. But it was a joy for me for the same reason, I hadn’t felt it in so long.

  3. I was nervous at first because I don’t like needles…But then once I actually took the drug a couple of times I realized that…it’s pretty easy. So, then it was fine. You never see the needle at all.

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FOOTNOTES

*The effectiveness and safety of Vyleesi were studied in two identical trials in over 1,200 premenopausal women with acquired, generalized HSDD for at least six months. Ages ranged from 19-56 years old, with an average age of 39 years old; 86% were White and 12% were Black. The trials had two phases: a 24-week Core Study Phase (24-week placebo-controlled, double-blind treatment period) and an uncontrolled, 52-week Open-label Extension Study Phase in which nearly 700 patients received Vyleesi. Most people who received Vyleesi used it two to three times per month and no more than once a week.

†Serious adverse reactions were reported in 1.1% of Vyleesi-treated patients and 0.5% of placebo-treated patients.

‡After completing the 24-week double-blind study period, 242 participants completed a voluntary exit survey to provide additional context to the clinical trial data. Consisting of 16 questions, the survey was conducted to understand the perceived effects and meaningfulness of Vyleesi. Additionally, a subset of the survey participants (80 women) also consented to be interviewed. 

Frequently Asked Questions
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  1. What is HSDD?

    See Answer

  2. What do you mean Vyleesi can be taken “as needed”?

    See Answer

  3. Who shouldn't take Vyleesi?

    See Answer
Get More Answers Here

Don't forget this part.
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IMPORTANT SAFETY INFORMATION

Do not use VYLEESI if you have:

  • high blood pressure that is not controlled (uncontrolled hypertension)
  • known heart (cardiovascular) disease

Before using VYLEESI, tell your healthcare provider about all of your medical conditions, including if you:

  • have high blood pressure.
  • have heart problems.
  • have kidney problems.
  • have liver problems.
  • are pregnant or plan to become pregnant. It is not known if VYLEESI will harm your unborn baby.
    • Women who can become pregnant should use effective birth control during treatment with Vyleesi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VYLEESI may affect the way other medicines work, and other medicines may affect the way VYLEESI works.

How should I use VYLEESI?
  • Inject Vyleesi at least 45 minutes before you think that you will begin sexual activity.
  • Do not inject more than 1 dose of VYLEESI within 24 hours of your last dose.
  • Do not inject more than 8 doses of VYLEESI within a month.
What are the possible side effects of VYLEESI?

VYLEESI can cause serious side effects, including:

  • Temporary increase in blood pressure and decrease in heart rate: An increase in blood pressure and decrease in heart rate can happen shortly after you inject VYLEESI. These changes usually go away within 12 hours after your injection. Increases in blood pressure and an increased risk of heart (cardiovascular) problems can happen if you use VYLEESI more often than prescribed by your healthcare provider.
  • Darkening of the skin on certain parts of the body (focal hyperpigmentation) including the face, gums (gingiva) and breast. The chance of darkening of the skin is increased in people with darker skin color. The chance of darkening of the skin is higher if VYLEESI is used every day. Darkening of the skin may not go away, even after you stop using VYLEESI.
  • Nausea. Nausea is common and can also be severe. Nausea most commonly happens after the first VYLEESI injection but can also happen after any dose of VYLEESI. The nausea usually lasts for about 2 hours but can last longer in some people. The nausea usually goes away by itself. Tell your healthcare provider if you have nausea that is severe or does not go away.

The most common side effects of VYLEESI include: flushing, injection site reactions, headache, vomiting, cough, fatigue, hot flush, tingling, dizziness, and nasal congestion. These are not all the possible side effects of VYLEESI.

Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact Palatin Technologies at 1-800-972-5220 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

INDICATION
What is VYLEESI?

VYLEESI is a prescription medicine used to treat hypoactive (low) sexual desire disorder (HSDD) in women who have not gone through menopause, who have not had problems with low sexual desire in the past, and who have low sexual desire no matter the type of sexual activity, the situation, or the sexual partner. Women with HSDD have low sexual desire that is troubling to them. Their low sexual desire is not due to:

  • a medical or mental health problem
  • problems in the relationship
  • medicine or other drug use

VYLEESI is not for the treatment of HSDD in women who have gone through menopause or in men.
VYLEESI is not for use to improve sexual performance.
VYLEESI is not for use in children.

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