FDA Approves First Gel for Erectile Dysfunction

The FDA authorized MED3000, a topical gel formulation to treat erectile dysfunction (ED).

MED3000, or Eroxon, will be available over the counter and is clinically proven to be effective for men at all levels of ED severity, whether psychological or organic, or mixed.

The treatment helps to achieve an erection within 10 minutes with no or little side effects, according to its manufacturer Futura Medical PLC.

In comparison, oral ED medications such as Cialis and Viagra are required to be taken at least 30 minutes in advance and are only available with a doctor’s prescription. Oral ED drugs cannot be taken in combination with a number of medications, such as nitrates for cardiovascular disease. To date, MED3000 has no known drug interactions.

MED3000 works by stimulating nerve endings on the head of the penis increasing blood flow and giving an erection. The gel is applied to the glans of the penis before intercourse, and the gel is massaged for 15 seconds.

One of the two phase-3 clinical trials compared MED3000 to oral tadalafil, an ED drug taken in 5mg tablets, over 24 weeks. At the end of the study, 85.4% of MED3000 users felt that sex could be spontaneous.

Although tadalafil showed a greater overall improvement in erectile function than MED3000, the gel achieved the FDA-agreed criteria for proving a rapid onset of action at 10 minutes when patients noticed an erection, whereas tadalafil did not.

As for side effects, only 4.3% of MED3000 users experienced a headache on at least one occasion while using the product, compared to 19.1% of tadalafil users.

MED3000 has already been approved in Belgium and the United Kingdom (UK), with multiple commercial agreements in Europe, Latin America, the Middle East, and South Korea.

Erectile dysfunction affects about 30 million men in the United States and refers to the inability to get or keep an erection firm enough for satisfactory sexual intercourse.