By William Elliott, MD, FACP, and James Chan, PharmD, PhD
Dr. Elliott is Assistant Clinical Professor of Medicine, University of California, San Francisco.
Dr. Chan is Associate Clinical Professor, School of Pharmacy, University of California, San Francisco.
The FDA has approved the first over-the-counter (OTC) topical gel to treat erectile dysfunction.1 This product is a formulation of glyceryl trinitrate (GTN) that is applied to the tip of penis. The FDA gave a “de novo” classification, which permits OTC sales as a medical device. GTN gel will be marketed in the United States as Eroxon.
INDICATIONS
GTN topical gel can be recommended to treat adult men (age 18 years and older) with erectile dysfunction.2 This is intended to help develop and keep an erection when one is sexually excited. It is not recommended for use in individuals whose physicians advise against sexual activity or those with Peyronie’s disease.
DOSAGE
Patients should massage the content of one tube (pea-sized amount) for at least 15 seconds to the head (glans) of the penis before intercourse. GTN gel is available as single-dose tubes.
POTENTIAL ADVANTAGES
The is the first OTC formulation to treat erectile dysfunction. The onset of action is faster and there are fewer side effects than phosphodiesterase-5 (PDE-5) inhibitors, such as sildenafil and tadalafil. There also are no food or drug interactions.
POTENTIAL DISADVANTAGES
There is a risk of application site reactions, such as coldness, irritation, or pain.3 In clinical studies, 3% of participants reported headache.4 Female partners reported mild “localized burning sensation.”4 There is a small risk of transfer of the drug to the partner, potentially leading to side effects, such as headache.3 Patients can use GTN with latex condoms to prevent transferring the gel to sexual partners.
COMMENTS
GTN is rapidly absorbed into corpus cavernosum, with associated nitric oxide release and increase in penile blood flow, and is positively associated with the ability to obtain an erection.3 The clinical effectiveness of GTN gel was demonstrated in two Phase III studies. Data were released by the manufacturer, but have not been published in a peer-reviewed journal.4 Study 1 (FM 57; n = 250) was 12 weeks in duration and was conducted in nine European countries. Researchers monitored sexual history for four weeks before treatment to establish the extent of erectile dysfunction. Investigators assessed changes in week 12 from baseline with the International Index of Erectile Function (IIEF) scale and the Sexual Encounter Profile (SEP) questions 2 and 3. Participants used these tools to detail their ability to develop and maintain an erection, as well as their ability to penetrate and achieve successful intercourse. About two-thirds of participants achieved or exceeded the minimal clinically important difference (four-unit change) over baseline of IIEF. The meaningful improvement percentage was greater in participants with severe erectile dysfunction vs. moderate or mild erectile dysfunction (80% vs. 59% and 61%). Study 2 (FM 71; n = 96) was a 24-week investigation that produced results similar to FM 57.4
CLINICAL IMPLICATIONS
Erectile dysfunction is a common disorder, affecting nearly 30 million Americans and 50% of men age 75 years or older.5 Patients should check with their physicians for underlying causes of their erectile dysfunction. When appropriate, the most common treatments are oral PDE-5 inhibitors (e.g., sildenafil, tadalafil).6
GTN gel offers a new approach to treating erectile dysfunction and is available without a prescription. The manufacturer states GTN will work for most men on their first or second attempt.2 GTN gel is available in the United Kingdom and Belgium, but its timeline for availability and cost in the United States is not clear.
REFERENCES
1. FDA. Device classification under section 513(f)(2)(de novo). Eroxon.
2. Futura Medical Developments Ltd. Eroxon product leaflet. July 2022.
3. Davis A, Reisman Y. Development of a novel topical formulation of glyceryl trinitrate for the treatment of erectile dysfunction. Int J Impot Res 2020;32:569-577.
4. Eroxon clinical trial data.
5. Harvard Health Publishing. Erectile dysfunction.
6. Burnett AL, Nehra A, Breau RH, et al. Erectile dysfunction: AUA guideline. J Urol 2018;200:633.
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Eroxon can be recommended to treat adult men (age 18 years and older) with erectile dysfunction.
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