Topical application of 10 minutes to take effect, ED new drug approved, the Indian miracle oil come true?

(2023年07月01日)

On June 12, the FDA approved MED3000 (trade name: Eroxon), a drug from British biotech company Futura Medical, for the treatment of erectile dysfunction (ED).

Eroxon is a topical gel that can be applied topically to help men get an erection in 10 minutes. Notably, it is the first over-the-counter (OTC) drug approved by the FDA for the treatment of ED.

Over-the-counter, works in 10 minutes in more than half of patients

Previously, the mainstay of ED treatment was phosphodiesterase type 5 inhibitors (PDE5i), represented by sildenafil. These drugs are available only by prescription and are usually taken orally 30 to 60 minutes before sexual activity.

Although PDE5 inhibitors have been widely used to treat ED for many years and are safe for most people, there may be some side effects. The literature suggests that sildenafil has systemic vasodilatory effects, so it should be used with caution in patients who are sensitive to changes in blood pressure, such as those with left ventricular outflow tract obstruction. Also, sildenafil administration may increase the incidence of non-arteritic anterior ischemic optic neuropathy (NAION) in men over 50 years of age [1].

On the official Eroxon website, Eroxon is advertised as easy to use, fast-acting, and safe. Before sexual activity, patients simply squeeze out a pea-sized amount of Eroxon gel and apply it to the penis for 15 seconds and massage it in. The official website states that Eroxon contains no "active pharmaceutical ingredients," and that it is primarily a localized, rapid cooling effect on the head of the penis through the physical evaporation of the volatile ingredients in the formula, followed by a gradual recovery and slow warming.

During the change, the nerve endings in the head of the penis are stimulated, increasing blood flow in the penis and thus enhancing erections.

Eroxon's official website published data from a Phase III clinical trial conducted in accordance with the FDA's recommended design. The trial enrolled 96 ED patients from three European countries and the United States, treated with Eroxon or a comparator product (a well-known prescription oral medication in the United States), and evaluated the efficacy, speed of action, and safety of Eroxon and the other product at various time points and at 24 weeks.

The results showed that Eroxon was clinically effective in 61% of ED patients at 24 weeks [2]. Officials show that more than 60% of patients saw an erection within 10 minutes of dosing, which the company says "is much faster than oral PDE5 inhibitors, making it easier to go for spontaneous intercourse rather than planning intercourse in advance.

In terms of side effects, the clinical data showed that 2% of men reported local side effects, while no local side effects were observed in female partners [2]. The safety of the product was also previously confirmed in another phase III clinical study. Local side effects were observed in 1% of men and 0.4% of female partners in more than 5000 intercourse sessions [2].

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