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).