Shots:

• Ken gave a brief overview of the OTC marketing approval of Eroxon (MED3000) by the US FDA. He also talked about Eroxon’s mechanism of action and how it helps to treat erectile dysfunction
• Later, he discussed the study design and results obtained from the clinical trial based on which the approval was granted. In addition, he gave a comparative view of Eroxon vs. existing treatments for erectile dysfunction, both prescription and OTC
• The interview highlights Futura’s portfolio of innovative products based on its proprietary, transdermal DermaSys® technology which has separately patented and designed formulations based on indication and application as well as optimized for clinical efficacy, safety, administration, and patient convenience

Smriti: Would you please give an overview of the recently granted OTC marketing authorization by the US FDA for the topical gel, Eroxon (MED3000) to treat erectile dysfunction?

Ken James: Eroxon is a clinically proven topical gel to treat Erectile dysfunction which helps men achieve an erection in 10 minutes for physical intimacy. It does not contain a drug substance and is classified as a medical device by virtue of its unique evaporative action. Because it is totally unique and there was no “predicate” or similar product to reference, the regulatory pathway to approval was through the “De Novo” process to create a new device type. This required Futura Medical to establish the effectiveness and safety of the product through a number of studies which were extensively reviewed by FDA Center for Devices and Radiological Health (CDRH). FDA CDRH agreed with our assessment that the benefits outweighed any risk to health and was suitable for OTC classification making Eroxon unique. Marketing authorisation was granted on June 9, 2023.

Smriti: Could you explain the mechanism of action of Eroxon and how it helps in treating erectile dysfunction?

Ken James: Eroxon gel is rubbed gently onto the glans penis (head of the penis) for approximately 15 seconds. It contains volatile components which rapidly evaporate and create a pleasant cooling and recovery warming sensation on the glans. The glans contains tiny nerve endings which are sensitized by this effect, and this ultimately leads to an increase of blood flow in the penis, tumescence and erection.

Smriti: Could you please tell us more about the trial design and the results obtained from the clinical trial based on which Eroxon was approved?  

Ken James: The clinical trial design was the subject of much discussion with FDA through a series of pre-submission meetings. FDA were reluctant to only accept results of the first large scale clinical study on Eroxon used to gain approval in Europe and required us to conduct an additional study over 24 weeks to eliminate the possibility that the product was acting only as a placebo. The primary endpoint had to achieve a clinically significant improvement over pre-treatment (baseline) levels of erectile dysfunction at 24 weeks. This was determined by exceeding a 4-unit change in the International Index of Erectile Functionality scale (IIEF-EF), the gold standard measure used in ED clinical trials. Eroxon achieved a score of 5.73 at 24 weeks and was shown to be effective in over 60% of subjects. The secondary endpoint was designed after discussion with FDA to quantify the onset of action. Eroxon was shown to help men get an erection in 10 minutes for physical intimacy, an important differentiating claim. The study also included a number of subjects who took tadalafil, to enable us to determine the relative benefit to risk profile against a leading prescription product. As expected, tadalafil was also clinically effective (in around 80% of subjects) but with a slower onset of action and an inferior systemic side-effect profile than Eroxon. The results therefore supported our hypothesis that the benefit to risk profile for Eroxon was suitable for OTC classification.

Smriti: How does Eroxon differ from other existing treatments for erectile dysfunction, both prescription and over the counter?

Ken James: Current prescription products used to treat ED are primarily “PDE5i” oral medications such as Viagra and Cialis. These typically take 30-60 minutes to work and can remain in the system for several hours. They also have systemic side-effects associated with them such as headache, back ache and flushing. As a result, up to 50% of men discontinue use within one year. Moreover, a barrier to PDE5i’s switching from prescription to OTC is the possibility of interaction with other prescription drugs such as nitrates often used to treat cardiovascular disease. This can lead to significant and potentially dangerous drops in blood pressure. Eroxon is a drug-free medical device and there are no significant systemic side-effects nor adverse drug/drug interactions making it suitable for OTC classification. A further differentiation over the PDE5i’s is the fast onset of action where no pre-planning for intercourse is required. There are a number of “fringe” OTC products available for treating ED such as vacuum pumps, but these are generally unattractive to users. Likewise on prescription, injections with alprostadil, suppositories, testosterone, shock wave therapy, surgery and implants are available but many ED sufferers regard these as too invasive and therefore don’t seek treatment for their condition. Eroxon provides a safe, effective and user-friendly alternative for those ED sufferers who for whatever reason currently remain untreated.  

Smriti: Shed some light on the regulatory approvals and market designations for Eroxon.

Ken James: Aside from FDA granting marketing authorisation, Eroxon is approved as a Class 2 medical device in Europe (OTC) and in a number of countries in the Middle East. Approvals are also being sought in other geographies. Eroxon has been launched in the UK and Belgium and will be rolled out in a number of additional countries during 2023/4.

Smriti: Are there any specific usage instructions or precautions that users should be aware of when using Eroxon?

Ken James: Eroxon is an effective and extremely safe product to use as proven in two clinical studies (over 5000 uses), and biocompatibility studies. As a precautionary measure, we warn users to stop use and ask a doctor if “you or your partner feel any irritation such as burning, itching or redness”. We also advise potential users when it may not be appropriate to use the product such as if they have been advised by their doctor to avoid sexual activity.

Smriti: How does Futura plan to address any scepticism from consumers regarding the effectiveness or safety of Eroxon?

Ken James: Experts agree that no one treatment for ED works for everyone. Eroxon has been shown in two clinical studies to be effective in over 60% of sufferers of ED of mild, moderate and severe ED and has been shown to be very safe in use. Our product labeling carefully explains the clinical performance of Eroxon in layman’s language and provides cautionary statements to ensure the safe use of the product.  

Smriti: Are you planning to use DermaSys drug delivery technology for any other drugs/ products?

Ken James: We continue to believe that DermaSys has great versatility as a topical drug delivery system and are exploring various avenues to maximize the value of DermaSys.

Image source: Canva

About the Author:

Ken James

Ken James is the Head of R&D at Futura Medical. He oversees the development, regulatory and manufacturing strategies for the Group’s existing pipeline and the evaluation of early-stage pipeline opportunities. He is also an Executive Director. He brings over 40 years’ experience in the research, development and commercialization of consumer healthcare products – previously having served as Senior Vice President of Research and Development for GlaxoSmithKline Worldwide Consumer Healthcare.

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