FDA approves new over-the-counter gel for erectile dysfunction

In this newsletter, we will discuss existing evidence for the use of topically administered treatments, for the management of ED. Alprostadil is available in the United States as an injectable for ED as well as an intraurethral suppository, but in other countries, there are alternatives such as intraurethral alprostadil. Vitaros is an intraurethral cream available in some European countries as well as Canada.

How Eroxon® works

Learn more about the Health Library and our editorial process. Cleveland Clinic’s health articles are based on evidence-backed information and review by medical professionals to ensure accuracy, reliability and up-to-date clinical standards. Alprostadil (Injectable and Transurethral) ( Updated 8/3/2021. Treasure Island, FL: StatPearls Publishing; 2023 Jan-. At Cleveland Clinic, we offer specialty care that’s focused on you.

Change of medication

Eroxon®, an over-the-counter (OTC) topical treatment for erectile dysfunction (ED) will be made available by Haleon in October 2024. The OTC gel is applied to the penis just before sex and has an onset of action of 10 minutes. The drug-free product produces a rapid cooling effect followed by a warming effect. This stimulates the nerve endings on the head of the penis, which then leads to vasodilation and erection. It was approved by the Food and Drug Administration in June 2023 and is intended for men aged 22 years and older experiencing ED. It is 3mg/g alprostadil and is packaged in single dose syringes carrying 100mg of cream, equivalent to 300mcg alprostadil.

Product	Dosage	Quantity + Bonus	Price
Viagra Generic	100mg	10 Pills	28.91€ 27.53€	Buy
Viagra Professional	100mg	10 Pills	44.09€ 41.99€	Buy
Super Kamagra	160 mg	152 + 8 Pills	729.11€ 694.39€	Buy
Levitra Original	20mg	64 + 4 Pills	298.45€ 284.24€	Buy
Kamagra Oral Jelly	100 mg	90 + 8 Sachets	303.56€ 289.10€	Buy
Viagra Original	100mg	8 Pills	59.84€ 56.99€	Buy
Kamagra 100 mg	100 mg	180 + 6 Pills	436.79€ 415.99€	Buy
Cialis Generic	40mg	270 + 10 Pills	382.19€ 363.99€	Buy
Levitra Professional	20mg	10 Pills	62.37€ 59.40€	Buy
Cialis Professional	20mg	180 + 4 Pills	423.11€ 402.96€	Buy
Apcalis SX Oral Jelly	20mg	50 + 6 Sachets	146.39€ 139.42€	Buy
Levitra Professional	20mg	120 + 4 Pills	348.44€ 331.85€	Buy

Phase II and III trials demonstrated up to 83% efficacy with this product with only 3% of the treated population reporting systemic adverse effects.3 In addition to intraurethral administration, some studies have also evaluated topical/transdermal use.

Explore related content

The average cost of alprostadil is over $500 for a 5-milliliter (teaspoon size) vial. The cost per dose depends on how much you need to inject, which varies from person to person. The lower the volume that you need to inject, the more doses per vial you’ll get, which makes it cheaper per dose. The cost of alprostadil may also depend on: The pharmacy where you pick up your prescription. Alprostadil can help treat erectile dysfunction and improve your sex life.

Introducing the First FDA-Cleared Over-the-Counter (OTC) Treatment for Erectile Dysfunction (ED).

ED can cause a lot of different feelings — frustration, embarrassment, shame and even humiliation. You may even experience these feelings when you seek help from a healthcare provider. But ED is common, and providers are available to help you and make you as comfortable as possible with your questions and concerns. Ask a provider if alprostadil is the best treatment for you or if another medication is better. Sign up for our Health Essentials emails for expert guidance on nutrition, fitness, sleep, skin care and more. One study of alprostadil 1% had patients apply 0.25ml of alprostadil 1% or placebo gel to the glans penis. The study reported better responses to the alprostadil treatment at all timepoints, with greatest differences noted at 45 and 60 minutes after application. The study noted that of the tested patients 38.9% in the treatment group and 6.9% in the placebo group achieved an erection deemed sufficient for penetration.4 Some studies have also evaluated papaverine HCl for transdermal use. One study of drug release of papaverine HCl in a gel vehicle found an alcohol-containing penetration enhancer resulted in drug penetration both in vitro and in vivo in rabbits.

• Innovations in ed gels include natural and herbal formulations.
• New delivery systems aim for enhanced penetration and reduced application time.
• They are continuously evolving to improve efficacy and patient experience.
• Research focuses on reducing side effects while maintaining effectiveness.

The study suggested that their results supported the use of penetration enhancer to deliver papaverine HCl transdermally.5 Another study evaluated 15% and 20% papaverine HCl gel applied to the scrotum, perineum, and penis.

• Ed gels may help in managing pain from tooth extractions or restorations.
• They are useful in treating sensitive teeth by desensitizing the area.
• Certain gels are formulated for specific age groups, including children.
• Ed gels should not be used on broken or severely inflamed tissue.

Patient response was evaluated 45 minutes after treatment.

• The effectiveness of ed gels depends on proper application and timing.
• They are less suitable for chronic pain, which requires comprehensive treatment.
• Ed gels can be combined with other topical agents for enhanced relief.
• Patients with allergies should review ingredients before use.

The treatment was well tolerated and papaverine HCl was minimally systemically absorbed, the researchers hypothesized that effects seen, mainly increase in duration of erection compared to placebo, were a result of local rather than systemic absorption.6 Phentolamine mesylate, while sometimes included in transdermal erectile dysfunction combination products, has not currently been studied in well controlled trials for its potentially efficacy via the transdermal route.

Understanding Topical ED Therapies: Why gels? The rationale behind topical delivery

The topical therapy has been shown to be safe and effective in two phase 3 clinical trials. Results from these studies showed over 60% of participants with mild, moderate or severe ED experienced a clinically meaningful improvement in erections with Eroxon. Seventy-one percent of participants were able to have penetrative sex within 15 minutes of application. The gel was also found to be safe and well tolerated. Eroxon is supplied in a single-dose tube.

Limitations and variability

The gel is compatible with latex and polyisoprene condoms, as well as lubricants. It has not been 100 sex tablet tested with contraceptive foams and gels. Individuals interested in pre-ordering Eroxon may do so through Amazon. The product includes 4 single-use tubes and retails for $25.99. Haleon announces the launch of Eroxon®, the first and only FDA cleared OTC gel for erectile dysfunction, available for US preorder without a prescription. Sildenafil is a PDE5 Inhibitor commercially available for oral use for ED, but there is some information to suggest that it may be efficacious transdermally as well. One placebo-controlled study compared sildenafil 1% gel to sildenafil 100mg tablets. The topical gel group applied 0.5g of sildenafil 1% gel to the glans of the penis approximately 5 minutes before sexual activity and the tablet group took a 100mg tablet 1 hour before sexual activity. In the gel group, 25% of patients achieved complete or moderate erections compared to 75% of the tablet group.

The Bottom Line on Erection Gels

You have swelling or pain in your testicles, perineum or legs. Veins in your legs start to swell. You develop flu-like symptoms, including fever, chills or nausea and vomiting. You develop scarring or hard areas on your penis. The alprostadil solution looks cloudy, is a different color or has debris.

4. Ayurvedic / OTC Gels (Example: Himalaya Himcolin)

Go to the nearest emergency room if your erection lasts longer than four hours. No, you shouldn’t combine alprostadil with other oral medications for ED. Taking alprostadil in combination with Viagra or other similar drugs may increase toxic effects. The most common complication includes a prolonged erection that lasts longer than four hours. Without proper treatment, it can cause permanent damage to your penile tissue. Though oral tablets demonstrated increased likelihood of complete or moderate erection, both groups did see benefit and onset of erection in the patients who applied sildenafil gel was 7.4 ±3.6 minutes, but was 37.8 ± 14.9 minutes in the group who used oral tablets.7 Though there aren’t many other studies on sildenafil cream topical for erectile dysfunction, other studies for conditions such as Raynaud’s have demonstrated benefit and increased blood flow as a result of local administration of sildenafil 5% cream, further suggesting that sildenafil may be absorbed from topical administration.8 Though currently information regarding other in vivo studies on other PDE5 inhibitors topically for erectile dysfunction are not available, some studies have found benefit for tadalafil used topically for Raynaud’s, suggesting transdermal penetration and potential local efficacy.9 Future studies are needed to confirm the potential of tadalafil as a topical treatment for erectile dysfunction.

Limitations of topical gels

Erectile dysfunction (ED) is a common patient concern, and its prevalence is strongly associated with age. Data from the US National Heath and Nutrition Examination Survey suggests that 8.2% of men between ages 40-49 years and 77.5% of men greater than 75 years old suffer from erectile dysfunction.1 The prevalence of ED was also associated with other conditions such as diabetes mellitus, smoking, cardiovascular disease, hypertension, and obesity.1 ED is most commonly managed with prescription phosphodiesterase-5 (PDE5) inhibitors used orally such as sildenafil, tadalafil, or vardenafil.1 Commercially available injectables for ED such as alprostadil or phentolamine mesylate injections are also sometimes used. Compounded options for ED often include combination injectable products such as phentolamine mesylate/papaverine HCl/alprostadil combinations, commonly referred to as “Tri-mix”. Tri-mix injections can be associated with serious side effects. One study evaluating trimix use and reasons for dropout in 189 patients noted that 30% of patients discontinued Tri-mix due to lack of efficacy, 5.2% experienced fibrosis or scarring, and 3.7% reported priapism.2 While Tri-mix works well for many patients, adverse effects make this route inappropriate for some patients creating a need for alternatives. Other active ingredients used transdermally to increase blood flow are sometimes also considered for combination topical ED mediations. Arginine, sometimes used at 3-6% in female sexual dysfunction creams, was found in a study of diabetic patients to improve blood flow. These patients applied transdermal arginine 12.5% cream to the feet and noted improved blood flow with a doppler flow meter and with an infrared thermometer 30 minutes after application.10 Despite this promising information, not enough data yet exists to suggest that arginine transdermal is appropriate for the management of ED. Though there is limited information to support transdermal application of medication for ED, some data exists to suggest efficacy.

Gel Type	Typical Shelf Life	Storage Temperature	Best Storage Conditions
Gelatin	6 months	Refrigerated	Cool, dry place
Agar-Agar	12 months	Room temperature	Keep sealed
Carrageenan	12-24 months	Cool, dry place	Shield from moisture
Pectin	1 year	Refrigerated	Freezer if long stored

The transdermal route could be considered for patients who prefer not to use oral or injectable medications. Check out the Fagron Academy site for related formulas. If you have further questions, feel free to reach out to Fagron Academy Technical Support Services! Relationship between age and erectile dysfunction diagnosis or treatment using real-world observational data in the United States.

• The development of ed gels focuses on maximizing bioavailability.
• They often contain flavoring agents to mask medicine taste.
• Some gels are formulated with rapid onset in mind, within 30 seconds.
• They play a critical role in minimally invasive dental treatments.

Drop-out reasons and complications in self-injection triple vasoactive drug mixture in sexual erectile dysfunction. Cuzin B. Alprostadil cream in the treatment of erectile dysfunction: clinical evidence and experience.