FDA greenlights first OTC topical gel for erectile dysfunction

12 Jun 2023
www.pharmaceutical-technology.com
Phase 3Clinical ResultDrug Approval
FDA greenlights first OTC topical gel for erectile dysfunction
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Source: Pharmaceutical Technology
Robert Barrie
FDA greenlights first OTC topical gel for erectile dysfunction
Preview
Source: Pharmaceutical Technology
Latin American man buying medicines at the drugstore while talking to the pharmacist
Patients with erectile dysfunction (ED) will now be able to access a topical treatment without the need for a prescription after the US Food and Drug Administration (FDA) greenlit Futura Medical’s Eroxon.
The over-the-counter (OTC) marketing authorisation for the gel as a de novo medical device means the FDA has followed suit after the treatment received CE marking in Europe and UKCA marking in the UK in 2021 and 2022, respectively.
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Shares in Futura Medical rose following the FDA nod – opening 28% higher than the previous day’s (June 9) close.
Eroxon, also known as MED3000, is directly applied to the glans of the penis and stimulates nerve sensors by a cooling and recovery warming effect. The evaporative mode of action leads to smooth muscle relaxation, with the company saying an erection is possible within 10 minutes. The mechanism is notably faster than popular oral medications such as sildenafil, known by the brand name Viagra and marketed by Pfizer, and tadalafil, which is marketed by Eli Lilly as Cialis. Both drugs have generic equivalents available and are PDE5 inhibitors that can take 30 to 60 minutes to kick in.
ED affects approximately 18% of men in the US.  The addition of a topical gel to pharmacy shelves expands treatment options available to those with ED. Whilst standard oral prescription treatments have high success rates, the onset delay and complications with alcohol and certain types of food mean they are not always easy to take regularly. Injection therapies that deliver alprostadil, such as Pfizer’s Cavarjet and Advanz Pharma’s Viridal, can also cause scarring on the penis.
The Guildford, UK-based Futura used data from two clinical studies to enable approval. Its FM57 Phase III study, conducted in Europe, demonstrated a clinically meaningful effect in over 60% of patients with ED.
A US confirmatory trial (FM71) investigated the gel compared to oral tadalafil (5mg) in 96 male patients with ED. Co-primary endpoints (agreed to with the FDA) of patient-reported improvement and a statistically important clinical difference were met at 24 weeks.
The gel is currently available in Belgium and the UK with commercial agreements in the European Economic Area, Switzerland, South Korea, Latin America, and the Middle East. Futura says it plans to continue launches throughout 2023.
Whilst the gel generates novel waves in the US, Sanofi plans to launch its own OTC treatment in the UK later in 2023. The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) has allowed Sanofi’s tadalafil-based Cialis Together to be purchased without a prescription.
In the same statement announcing the FDA approval, Futura also announced it raised £4.3m ($5.4m) via a warrant exercise by Lombard Odier.
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