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First-Ever OTC Gel for Erectile Dysfunction Receives US-FDA Approval

United States: The FDA approved the sale of an over-the-counter topical therapy for erectile dysfunction in men with stocks set to be available by 2025. Eroxon gel from Futura Medical can now be marketed as de novo medical device. In the United States, erectile dysfunction affects about 18% of men.  The number of treatments accessible to those with erectile dysfunction has increased with the addition of a topical gel to drugstore shelves. Although traditional oral prescription therapies have high success rates, they are not always simple to take regularly due to the beginning delay and difficulties with alcohol and certain types of food. Eroxon, often referred to as MED3000, is administered directly to the penis glans and works to stimulate nerve receptors by cooling and warming the area. The manufacturer claims that an erection is attainable in as little as 10 minutes once the smooth muscles are relaxed as a result of the evaporative mode of action.

In addition, Futura Medical disclosed that it has received a notice of warrant exercise from Lombard Odier Asset Management (Europe) Limited ("Lombard Odier") for 10,937,500 ordinary shares of the company worth 0.2 pence (the "Ordinary Shares"), at an exercise price of 40 pence per share. The Company will receive 5515037.50 USD in compensation for the exercise of the warrant. The United Kingdom and Belgium already carry Eroxon and the cost of a four-pack of Eroxon in the United Kingdom is approximately 31.50 USD. That is roughly the same as 31.22 USD in the United States.

According to the Chief Executive Officer of Futura Medical, “The granting of marketing authorization by the US FDA as the first clinically proven, topical gel for the treatment of ED in the USA available without a doctor’s prescription is a huge milestone for Futura and highlights the incredible progress that the Company continues to make. FDA set a very high standard in evaluating the effectiveness and safety of De Novo Medical Devices. I am delighted that we met this standard with MED3000’s submission of 22 clinical, biocompatibility, human factors studies and performance bench tests which were rigorously reviewed and accepted by the FDA. The FDA approval is a major de-risking event for the Company, and we look forward to updating shareholders on our US commercialization plans in due course”.

According to TechSci Research, Erectile dysfunction can have various causes, including physical, psychological, or a combination of both. Physical causes may include underlying medical conditions such as cardiovascular disease, diabetes, hormonal imbalances, neurological disorders, or side effects of certain medications. Psychological factors can include stress, anxiety, depression, relationship issues, or performance anxiety. Treatment for erectile dysfunction depends on the underlying cause and may involve a combination of lifestyle changes, counseling, medication, or other medical interventions. Lifestyle modifications such as maintaining a healthy weight, regular exercise, quitting smoking, reducing alcohol consumption, and managing stress can have a positive impact on erectile dysfunction.

While the gel is making headlines in the United States, Sanofi plans to introduce its own over-the-counter medication in the United Kingdom later in 2023. Sanofi's tadalafil-based Cialis Together is now available over the counter in the United Kingdom thanks to the Medicine and Healthcare products Regulatory Agency (MHRA).

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