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Haleon Announces the Launch of Eroxon®, The First and Only FDA Cleared OTC Gel for Erectile Dysfunction, Available for U.S. Preorder Without a Prescription

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Haleon has launched Eroxon®, the first FDA-cleared over-the-counter gel for erectile dysfunction (ED) in the U.S. Available for pre-order on Amazon and in major retailers by October 2024, Eroxon® is clinically proven to help men achieve erections within 10 minutes. This fast-acting treatment addresses a significant unmet need, as existing prescription solutions can take up to an hour to work.

Clinical studies demonstrate Eroxon®'s safety and efficacy for men with ED. The gel stimulates nerve endings in the penis to aid in achieving and maintaining erections. Haleon aims to make this accessible treatment available to millions of American men affected by ED, emphasizing the importance of sexual health in overall wellness.

Haleon ha lanciato Eroxon®, il primo gel da banco approvato dalla FDA per la disfunzione erettile (DE) negli Stati Uniti. Disponibile per il pre-ordine su Amazon e presso i principali rivenditori entro ottobre 2024, Eroxon® è clinicamente provato per aiutare gli uomini a raggiungere un'erezione entro 10 minuti. Questo trattamento ad azione rapida risponde a un bisogno significativo, poiché le soluzioni prescritte esistenti possono richiedere fino a un'ora per funzionare.

Studi clinici dimostrano la sicurezza e l'efficacia di Eroxon® per gli uomini con DE. Il gel stimola le terminazioni nervose nel pene per contribuire a raggiungere e mantenere le erezioni. Haleon mira a rendere questo trattamento accessibile a milioni di uomini americani colpiti dalla DE, sottolineando l'importanza della salute sessuale nel benessere generale.

Haleon ha lanzado Eroxon®, el primer gel de venta libre aprobado por la FDA para la disfunción eréctil (DE) en los EE. UU. Disponible para prepedido en Amazon y en los principales minoristas para octubre de 2024, Eroxon® ha demostrado clínicamente ayudar a los hombres a lograr erecciones en 10 minutos. Este tratamiento de acción rápida aborda una necesidad importante no satisfechada, ya que las soluciones prescritas existentes pueden tardar hasta una hora en hacer efecto.

Los estudios clínicos demuestran la seguridad y eficacia de Eroxon® para hombres con DE. El gel estimula las terminaciones nerviosas en el pene para ayudar a lograr y mantener erecciones. Haleon busca hacer que este tratamiento accesible esté disponible para millones de hombres estadounidenses afectados por DE, enfatizando la importancia de la salud sexual en el bienestar general.

헤일론은 미국에서 발기부전 (ED)을 위한 최초의 FDA 승인 일반의약품 젤인 Eroxon®을 출시했습니다. Eroxon®은 2024년 10월까지 아마존과 주요 소매점에서 사전 주문할 수 있으며, 10분 이내에 남성들이 발기를 도와주는 것으로 임상적으로 입증되었습니다. 이 신속 작용 치료법은 기존의 처방 솔루션이 작동하는 데 최대 한 시간이 걸릴 수 있는 점에서 중요한 미충족 요구를 해결합니다.

임상 연구는 ED가 있는 남성에게 Eroxon®의 안전성과 효능을 입증합니다. 이 젤은 발기를 달성하고 유지하는 데 도움을 주기 위해 음경의 신경 말단을 자극합니다. 헤일론은 ED로 영향을 받는 수백만 미국 남성들에게 이 접근 가능한 치료법을 제공하는 것을 목표로 하며, 전체적인 웰빙에서 성 건강의 중요성을 강조하고 있습니다.

Haleon a lancé Eroxon®, le premier gel en vente libre approuvé par la FDA pour la dysfonction érectile (DE) aux États-Unis. Disponible en précommande sur Amazon et dans les principaux détaillants d'ici octobre 2024, Eroxon® a prouvé cliniquement qu'il aide les hommes à obtenir une érection en 10 minutes. Ce traitement à action rapide répond à un besoin non satisfait significatif, les solutions sur ordonnance existantes pouvant prendre jusqu'à une heure pour agir.

Les études cliniques démontrent la sécurité et l'efficacité d'Eroxon® pour les hommes atteints de DE. Le gel stimule les terminaisons nerveuses dans le pénis pour aider à obtenir et à maintenir des érections. Haleon vise à rendre ce traitement accessible à des millions d'hommes américains touchés par la DE, soulignant l'importance de la santé sexuelle dans le bien-être général.

Haleon hat Eroxon® eingeführt, das erste rezeptfreie Gel in den USA, das von der FDA gegen Erektionsstörungen (ED) zugelassen ist. Eroxon® kann ab Oktober 2024 zur Vorbestellung auf Amazon und in großen Einzelhandelsgeschäften erhältlich sein und hat sich klinisch als wirksam erwiesen, um Männern in 10 Minuten zu helfen, eine Erektion zu erreichen. Diese schnell wirkende Behandlung deckt ein bedeutendes unbefriedigtes Bedürfnis ab, da bestehende rezeptpflichtige Lösungen bis zu einer Stunde benötigen können, um zu wirken.

Klinische Studien belegen die Sicherheit und Wirksamkeit von Eroxon® bei Männern mit ED. Das Gel stimuliert die Nervenenden im Penis, um zu helfen, Erektionen zu erreichen und aufrechtzuerhalten. Haleon zielt darauf ab, diese zugängliche Behandlung Millionen von amerikanischen Männern mit ED zur Verfügung zu stellen und betont die Bedeutung der sexuellen Gesundheit für das allgemeine Wohlbefinden.

Positive
  • First FDA-cleared OTC gel for erectile dysfunction in the U.S.
  • Clinically proven to work within 10 minutes, faster than existing prescription solutions
  • Available for pre-order on Amazon, with wide retail distribution planned for October 2024
  • Addresses a significant unmet need in the ED treatment market
  • Expands Haleon's product portfolio into the sexual health space
Negative
  • None.

Insights

Haleon's launch of Eroxon®, the first FDA-cleared OTC gel for erectile dysfunction (ED), marks a significant milestone in sexual health treatment. The gel's rapid onset of action (within 10 minutes) addresses a important unmet need, potentially disrupting the market dominated by prescription medications with longer onset times.

Clinical studies demonstrating Eroxon®'s safety and efficacy in men with ED are promising. However, it's important to note that the product's long-term effects and potential interactions with other medications remain to be seen in real-world usage. The gel's mechanism of action, stimulating nerve endings in the penis, differs from oral ED medications, which could lead to a different side effect profile.

The OTC availability could significantly increase accessibility for millions of men affected by ED, potentially leading to improved quality of life and relationships. However, this also raises concerns about proper usage and the potential for men to bypass important medical consultations that could identify underlying health issues causing ED.

Haleon's entry into the sexual health market with Eroxon® represents a strategic move to tap into a lucrative segment. The global erectile dysfunction market was valued at $3.9 billion in 2022 and is projected to grow at a CAGR of 6.8% from 2023 to 2030. As the first OTC option, Eroxon® could capture a significant market share, especially among younger men who may be hesitant to seek prescription treatments.

The product's availability through major retailers and Amazon pre-orders indicates a robust distribution strategy. However, success will depend on effective marketing to overcome potential stigma and educate consumers about this new treatment option. The October 2024 launch timing allows for a comprehensive awareness campaign.

Investors should monitor initial sales figures and consumer reception closely, as these will be important indicators of Eroxon®'s market penetration and Haleon's potential revenue growth in this new segment. The product's performance could significantly impact Haleon's stock valuation in the coming years.

  • Eroxon® is Haleon's first offering in the sexual health space
  • Clinical studies show Eroxon® is safe and effective in men with ED
  • Eroxon® is available now for Amazon pre-order; available on shelves and online at most major retailers in October 2024

WARREN, N.J., Sept. 3, 2024 /PRNewswire/ -- Eroxon®, the first-and-only FDA cleared gel available without a prescription for the treatment of erectile dysfunction (ED), is now available for pre-order in the United States through Amazon and will be available at most major retailers in October 2024.

Eroxon® is clinically proven to help men get an erection within 10 minutes to foster physical intimacy (individual results may vary). The treatment stimulates nerve endings in the penis to help men with ED get and maintain an erection during sex. Given existing prescription solutions may take up to an hour to work (based on labels), Eroxon® addresses a significant unmet need for men experiencing ED.

Clinical study results show that Eroxon® is safe and effective in men with ED. While ED can be caused by underlying physical conditions, psychological challenges such as stress, anxiety, depression, and other mental health issues may also contribute to ED, especially in younger men. Eroxon® aims to help men with ED enhance intimacy and connection in their relationships, fostering closer and more fulfilling partnerships.

Lisa Paley, President, North America at Haleon, said: "At Haleon, we have a clear purpose to deliver better everyday health with humanity. Introducing Eroxon to U.S. consumers reflects our belief that sexual health is a critical part of wellness. We understand how important making meaningful and intimate connections are to one's wellbeing, and Eroxon helps achieve just that. We are proud to take this bold step to make this first-of-its-kind over-the-counter (OTC) gel treatment accessible to the millions of men in the U.S. who are affected by ED."

Gerald Brock, MD, FRCSC, Haleon Partner, said: "The body of scientific evidence for Eroxon supports it as an effective, fast-acting, and accessible OTC ED treatment with an excellent safety profile."

How to use Eroxon®:

  • Unscrew cap. Pierce the tube seal with top of cap.
  • Squeeze tube firmly to empty all the contents onto finger(s), which will provide the correct dose.
  • Massage the gel onto the head of your penis for about 15 seconds. If you are uncircumcised, gently pull your foreskin back as far as comfortable before applying the gel. It may take a few attempts to achieve the desired effect.
  •  You can apply the gel, or your partner can apply the gel to your penis as part of foreplay. In a clinical study, partners applied the product for the male as part of foreplay, which resulted in better outcomes.

For more information on Eroxon® and ED, visit eroxon.us, and to preorder visit Amazon.

About Erectile Dysfunction
ED is a common condition, impacting 1 in 4 men over the age of 221 – that's 30 million men.2 Men with ED may have trouble getting or maintaining an erection firm enough for sexual activity. Some men have trouble on occasion, while others may not be able to get an erection at all. ED typically becomes more prevalent as you age, impacting half of men over the age of 40.3 However, mild-to-moderate symptoms often go undetected and untreated, especially in younger men. For more information about erectile dysfunction (ED), please visit our website eroxon.us.

About Eroxon®
Eroxon®, launched by Haleon in the United States, is the first-and-only FDA cleared gel available without a prescription for the treatment of erectile dysfunction (ED). The treatment works directly on the penis to stimulate nerve endings leading to increased blood flow to help men get and keep an erection for sex/intimacy. Eroxon® is a convenient and accessible ED treatment for millions of men. For more information, please visit our website eroxon.us.

About Haleon U.S.
Haleon (NYSE: HLN) is a leading global consumer health company with a purpose to deliver better everyday health with humanity.  Haleon's product portfolio spans five major categories: Oral Health, Pain Relief, Respiratory Health, Digestive Health, and Wellness. Built on trusted science, innovation, and deep human understanding, Haleon's U.S. brands include Abreva, Advil, Benefiber, Centrum, Emergen-C, Excedrin, Flonase, Gas-X, Nexium, Nicorette, Parodontax, Polident, Preparation H, Pronamel, Sensodyne, Robitussin, Theraflu, TUMS, Voltaren, and more. For more information on Haleon and its brands, please visit www.haleon.com or contact USMediaRelations@haleon.com

  1. Selvin E, Burnett A, Platz E Prevalence and risk factors for erectile dysfunction in the U S Am Jour of Med 2007 (120) 151-157
  2. National Institutes of Health (NIH) website http://kidney niddk nih gov/kudiseases/pubs/ED/index aspx Downloaded 5/14/12
  3. Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol. 1994 Jan;151(1):54-61. doi: 10.1016/s0022-5347(17)34871-1. PMID: 8254833.

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SOURCE Haleon

FAQ

When will Eroxon be available in U.S. stores for Haleon (HLN) stock investors?

Eroxon will be available in most major U.S. retailers in October 2024. It is currently available for pre-order on Amazon.

How quickly does Haleon's (HLN) Eroxon work compared to existing ED treatments?

Eroxon is clinically proven to help men get an erection within 10 minutes, while existing prescription solutions may take up to an hour to work, according to their labels.

Is Haleon's (HLN) Eroxon FDA approved for over-the-counter use?

Yes, Eroxon is the first and only FDA-cleared over-the-counter gel for the treatment of erectile dysfunction in the United States.

What is the target market for Haleon's (HLN) new Eroxon product?

Eroxon targets the millions of men in the U.S. affected by erectile dysfunction, including those experiencing ED due to physical conditions or psychological challenges such as stress and anxiety.

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