Addyi vs Vyleesi

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Overview

Addyi

Vyleesi

Effectiveness

Safety

Cost

Market Analysis

Conclusion

Introduction

Addyi and Vyleesi are two drugs prescribed for premenopausal women experiencing distress due to low sexual desire, a condition known as hypoactive sexual desire disorder (HSDD). Both medications work differently in the body to help manage this symptom. Addyi is classified as a non-selective serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, affecting levels of several neurotransmitters in the brain associated with mood and motivation. On the other hand, Vyleesi acts as a melanocortin receptor agonist that activates pathways in the brain involved in normal sexual response. These fundamental differences mean that each drug may be more suitable for different individuals based on their specific symptoms and overall health status.

What is Addyi?

Flibanserin (the generic name for Addyi) was the first drug of its kind, developed to treat hypoactive sexual desire disorder (HSDD) in premenopausal women. Flibanserin was first approved by the FDA in 2015. Addyi works by modulating neurotransmitters such as dopamine, norepinephrine and serotonin in the brain, with a particular focus on increasing dopamine and norepinephrine (both responsible for sexual excitement), while reducing serotonin levels (responsible for sexual inhibition). However, unlike Prozac which is selective in its influence on serotonin with minor effects on other neurotransmitters resulting in fewer side effects; Addyi influences several neurotransmitters which might lead to more pronounced side effects.

On the other hand, Bremelanotide (the generic name for Vyleesi), also intended to address HSDD in premenopausal women but via a different mechanism of action. Approved by the FDA four years after Addyi's approval - it activates melanocortin receptors involved in many biological functions including mood and appetite but importantly here – sexual responses. Unlike daily regimen required with flibanserin, bremelanotide is used 'as needed'. While both drugs can have side-effects such as nausea or fainting due to blood pressure drop; Vyleesi doesn't require avoiding alcohol intake like you would need with flibanserin use.

What conditions is Addyi approved to treat?

Addyi and Vyleesi are approved for the treatment of different sexual dysfunctions in women:

  • Addyi (flibanserin) is indicated for the treatment of premenopausal women suffering from hypoactive sexual desire disorder (HSDD). This condition is characterized by a persistent or recurrent lack of interest in sex that causes personal distress.

  • Vyleesi (bremelanotide) has been approved to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Unlike Addyi, which is taken daily, Vyleesi is used as needed before sexual activity.

How does Addyi help with these illnesses?

Addyi (Flibanserin) is designed to treat hypoactive sexual desire disorder (HSDD) in premenopausal women by altering the balance of certain neurotransmitters in the brain, specifically dopamine and norepinephrine which are increased, and serotonin which is decreased. The drug works by affecting these chemicals' pathways in the prefrontal cortex, a part of the brain that is associated with motivational aspects of behavior such as sex drive. Addyi improves sexual desire by balancing these neurotransmitter effects.

Vyleesi (Bremelanotide), on the other hand, also treats HSDD but through a different mechanism. It activates melanocortin receptors involved in many biological functions including skin pigmentation and appetite regulation. However, its exact process for improving female sexual desire isn't fully understood yet. Vyleesi can be used when needed rather than daily like Addyi – it's administered via an injection under the skin at least 45 minutes before anticipated sexual activity.

What is Vyleesi?

Vyleesi, known generically as bremelanotide, is a melanocortin receptor agonist. It works by activating pathways in the brain involved in sexual response, thereby increasing sexual desire. Vyleesi was approved by the FDA in 2019 for premenopausal women with hypoactive sexual desire disorder (HSDD). Unlike Addyi which is taken daily regardless of planned sexual activity, Vyleesi is used only when needed before sexual activity and does not require daily administration. This means that its side effect profile can be different from that of Addyi's: it doesn't cause sedation nor does it have to be avoided with alcohol (a notable limitation of Addyi). However, common side effects may include nausea or vomiting along with temporary skin reactions at the injection site. The on-demand nature of Vyleesi might make it a suitable option for those who do not respond well to or find themselves inconvenienced by 'typical' HSDD drugs such as Addyi.

What conditions is Vyleesi approved to treat?

Vyleesi is approved for the treatment of:

  • Pre-menopausal women experiencing hypoactive sexual desire disorder (HSDD)
  • HSDD in certain situations where the low sexual desire is not due to: a co-existing medical or psychiatric condition, problems within the relationship, or effects of medication or other drug substances

How does Vyleesi help with these illnesses?

Melanocortin is a hormone that plays multiple roles in the body, including influencing sexual arousal and physical responses to sex. Vyleesi works by activating melanocortin receptors in the brain, thereby potentially boosting sexual desire and decreasing distress related to low sexual desire. Unlike Addyi, which needs to be taken daily regardless of planning for sexual activity, Vyleesi can be used on an as-needed basis prior to anticipated sexual activity. Its action suggests it's less reliant on serotonin levels than drugs like Addyi; therefore it may be considered when a patient does not respond well or wishes to avoid potential side effects associated with daily intake medications for treating hypoactive sexual desire disorder (HSDD).

How effective are both Addyi and Vyleesi?

Both flibanserin (Addyi) and bremelanotide (Vyleesi) are FDA-approved medications for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD). They were approved by the FDA only four years apart. Since they act on different receptors in the body, they may be prescribed under different circumstances. The effectiveness of Addyi and Vyleesi in alleviating symptoms of HSDD was directly studied in several double-blind clinical trials; both drugs exhibited similar efficacy as well as promising safety profiles.

A 2016 review demonstrated that Addyi is effective at increasing sexually satisfying events per month and reducing distress associated with low sexual desire starting from eight weeks into treatment. Its side effect profile includes dizziness, somnolence, nausea, fatigue which are mild to moderate in severity but it has a black-box warning due to severe hypotension and syncope seen when taken with alcohol or hepatic impairment.

On the other hand, Vyleesi acts by activating melanocortin receptors involved in many biological functions including skin pigmentation and appetite regulation along with sexual arousal responses. It is administered via subcutaneous injection prior to anticipated sexual activity rather than daily use as for Addyi. A 2020 meta-analysis indicated that Vyleesi increased sexually satisfying events per month compared placebo; however, its use involves significant side effects like nausea,vomiting flushing reactions,and headache among others.

In conclusion both these drugs provide therapeutic options for managing HSDD but should be selected according to individual patient's needs considering their administration pattern ,efficacy expectations , tolerability factors etc .

abstract image of a researcher studying a bottle of drug.

At what dose is Addyi typically prescribed?

Oral dosages of Addyi are typically 100 mg/day, taken at bedtime. This is crucial as taking it during waking hours can increase the risk of low blood pressure, fainting and accidental injury. Vyleesi, on the other hand, is not a daily medication but an autoinjector pen that's used in the thigh or abdomen at least 45 minutes before anticipated sexual activity. It should not be used more than once within 24 hours or more than eight times per month. Both drugs require ongoing evaluation to determine if their benefits continue to outweigh their risks.

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At what dose is Vyleesi typically prescribed?

Vyleesi treatment typically begins with an auto-injector pen that delivers a 1.75 mg dose under the skin of your stomach or thigh, at least 45 minutes before anticipated sexual activity. The maximum recommended dosage is one injection per day and no more than eight injections per month. Unlike daily oral medications like Addyi, Vyleesi is used only when needed, which allows for greater flexibility and less overall exposure to medication if sexual activity isn't frequent. It's important to note that it may take several doses before you notice an improvement in your sexual desire and distress levels, so be patient as your body adjusts to this new treatment regimen.

What are the most common side effects for Addyi?

Common side effects of Addyi include:

  • Dizziness
  • Somnolence (sleepiness/drowsiness)
  • Nausea
  • Fatigue (general weakness and tiredness)
  • Insomnia
  • Dry mouth
  • Decreased libido (sex drive)

On the other hand, typical side effects of Vyleesi may include:

  • Nausea
  • Flushing (warmth, redness, or tingly feeling under your skin)
  • Injection site reactions (pain, itching, rash or swelling)
    Remember that both drugs are used to treat hypoactive sexual desire disorder in women who have not undergone menopause. It's important to note that these medications should only be taken after consulting with a healthcare professional.

abstract image of a patient experiencing side effect

Are there any potential serious side effects for Addyi?

While using Addyi or Vyleesi, a small number of people may experience severe side effects that require immediate medical attention. These could include:

  • Increased thoughts about self-harm or suicide
  • Signs of an allergic reaction such as hives, difficulty in breathing, swelling on your face or throat
  • Severe skin reactions like red or purple skin rash with blistering and peeling
  • Changes in vision including blurred vision, tunnel vision, eye pain or seeing halos around lights
  • Cardiac symptoms such as fast heartbeats, fluttering in the chest, shortness of breath and sudden dizziness (as if you might faint)
  • Symptoms indicative of low sodium levels - headache confusion slurred speech severe weakness vomiting loss of coordination feeling unsteady
  • Severe nervous system reaction very stiff muscles high fever sweating confusion fast heartbeat tremors feeling like you might pass out. In rare cases users have reported symptoms similar to serotonin syndrome: restlessness hallucinations fever excessive perspiration shivering rapid heart rate muscle stiffness twitching loss of coordination nausea vomiting diarrhea. If any these symptoms occur stop taking either drug immediately consult with healthcare professional.

What are the most common side effects for Vyleesi?

Vyleesi, a medication designed to enhance female libido, may present with the following side effects:

  • Nausea or vomiting
  • Flushing and redness of the skin
  • Headache
  • Injection site reactions such as pain or bruising
  • Cough or nasal congestion
  • Fatigue or dizziness
  • Temporary darkening of the skin around specific parts like face and breasts

It is important to note that Vyleesi should not be used in people with uncontrolled high blood pressure or heart disease. Always consult your healthcare provider before starting any new treatment regimen.

Are there any potential serious side effects for Vyleesi?

While Vyleesi is generally well-tolerated by most people, there are potential side effects to consider:

  • Allergic reactions could occur, signs of which include a skin rash, itching or hives, swelling of the face, lips or tongue.
  • Some patients may experience an increase in blood pressure and decrease in heart rate.
  • Nausea is quite common after taking Vyleesi and can sometimes be severe.
  • Darkening of the skin on parts of your body such as the face, gums and breasts (known as hyperpigmentation) might occur.
  • Other possible symptoms include headache, flushing or hot flushes.

You should always consult with your healthcare provider if you notice these symptoms persisting or worsening over time.

Contraindications for Addyi and Vyleesi?

Both Addyi and Vyleesi, similar to other medications intended for the treatment of hypoactive sexual desire disorder (HSDD) in women, may lead to certain side effects. If you notice severe nausea, fainting or any sudden changes in your health after taking these medicines, please seek immediate medical help.

Addyi cannot be taken if you consume alcohol or have liver problems. It is also prohibited if you are taking moderate or strong inhibitors of CYP3A4 (an enzyme that metabolizes drugs), including certain antibiotics and antifungal medications.

Vyleesi should not be used by women with uncontrolled high blood pressure or heart disease. Also, it's advised not to use this medication if you have liver disease or kidney problems unless prescribed by a doctor.

Always inform your healthcare provider about all the medicines you take; some could interact with Addyi and Vyleesi causing serious harm. For example, using either drug while on naltrexone can block its effect and potentially increase levels of distress related to HSDD.

How much do Addyi and Vyleesi cost?

For the brand name versions of these drugs:

  • The price of 30 tablets of Addyi (100 mg) averages around $846, which works out to approximately $28/day.
  • The price for a package containing four doses of Vyleesi (1.75mg/0.3ml pre-filled autoinjector pen) is about $888, working out to roughly $222 per dose or use.

Thus, if you are using Vyleesi more than once every eight days, then brand-name Addyi could be less expensive on a per-day basis. Please note that cost should not be your primary consideration in determining which drug may be more suitable for you.

As for generic versions: as far as it's known at the time this article was written, there are no available generic equivalents either for flibanserin (Addyi) or bremelanotide (Vyleesi).

Popularity of Addyi and Vyleesi

Flibanserin, marketed under the brand name Addyi, is a medication approved for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). As per recent data, its usage appears to be relatively low. In 2019, it was reported that about 650 prescriptions were written monthly for Addyi in the United States. Flibanserin's market share has been rather steady since its introduction in 2015.

Bremelanotide, sold under the brand name Vyleesi, is another drug used to treat HSDD in premenopausal women and was approved by FDA more recently than flibanserin - in June 2019. It’s too early to assess prescription trends for Bremelanotide due to limited available data; however initial uptake suggests it may have a similar volume of use as Flibanserin.

Both medications are "firsts" within their specific pharmacologic class for this indication and represent part of an ongoing effort to address female sexual dysfunction pharmacologically.

Conclusion

Both Addyi (flibanserin) and Vyleesi (bremelanotide) are approved for the treatment of premenopausal women with hypoactive sexual desire disorder (HSDD). They have been proven to be more effective than placebo treatments in clinical studies, but their uses are limited due to side effects. Their mechanisms of action differ; Addyi acts on serotonin receptors in the brain, while Vyleesi activates melanocortin receptors.

Addyi is usually given as a first-line treatment option and must be taken daily at bedtime to reduce adverse reactions such as hypotension and syncope associated with higher blood levels during waking hours. On the other hand, Vyleesi is administered via subcutaneous injection about 45 minutes prior to anticipated sexual activity or once per day as needed.

Both medications come only in brand-name forms currently, which might represent significant cost issues for patients paying out of pocket. Both Addyi and Vyleesi may require an adjustment period when starting therapy – this means that beneficial effects might not be noticeable right away.

The side effect profile varies between the two drugs: common adverse events reported with Addyi include dizziness, somnolence, nausea while those reported with Vyleesi include nausea, flushing, injection site reactions. For both drugs patients should closely monitor their well-being especially when starting treatment and seek medical help immediately if they experience severe side effects.