FDA’s Approval Of Eroxon Part Of Trend Toward More OTC Treatments

On June 13th, a topical gel named Eroxon was approved by the Food and Drug Administration (FDA) under the de novo medical devices classification as an over-the-counter (OTC) erectile dysfunction treatment. Eroxon’s approval appears to be part of an ongoing trend in which OTC availability of products is increasing in therapeutic classes which were formerly off limits to OTC drugs. This also includes the opioid antagonist Narcan and the likely imminent approval of Opill, an oral contraceptive.

It’s not known when exactly Eroxon will be available in pharmacies in the U.S., nor has the price been announced. But the product’s manufacturer, Futura Medical, has launched the OTC product in a few European countries in Europe. The company intends to continue launches in European jurisdictions throughout 2023.

In the U.K., where Eroxon is in pharmacies and available OTC, the product costs the equivalent of about $31 for a four-pack.

The gel’s mechanism of action involves stimulating nerve sensors by a cooling and recovery warming effect. The company says an erection is possible within 10 minutes. In addition, Phase 3 trial data demonstrated a clinically meaningful effect in more than 60% of patients.

Eroxon’s mode of action is faster than oral medications such as Viagra (sildenafil) and Cialis (tadalafil). Both drugs—which have generic equivalents available—are PDE5 inhibitors, which relax blood vessels and increase blood flow, but can take 30 to 60 minutes to kick in.

Pharmaceutical giant Sanofi is pursuing a U.S. switch of its tadalafil product from prescription-only to OTC, but in 2022 encountered an FDA-imposed pause related to the protocol design of its actual use trial. The company plans to launch OTC Cialis in the U.K. later this year, after getting OTC approval from the Medicine and Healthcare Products Regulatory Agency The U.K. isn’t the only nation with OTC tadalafil, as Poland in 2019 became the first country in the world to allow tadalafil to be obtained without a prescription. Poles can also purchase OTC sildenafil, as consumers can in the U.K. and Norway, but not in the U.S.

In countries such as the U.K. and Norway, perhaps having a behind the counter alternative to off-the-shelf OTC helps facilitate more switches. Norway’s new “non-prescription medicines with guidance” category of medicines, for example, may have assisted in making sildenafil’s switch possible.

For many years, the U.K. pharmacy system has had a subgroup of OTC medications available that are behind the counter. This implies that unlike other OTC medicines sold in-aisle or off-the-shelf, obtaining behind-the-counter products requires the assistance of a pharmacist.

When determining whether to allow prescription drugs to be sold OTC, the U.S. FDA weighs whether patients are able to understand complex aspects of their condition and when to take the drug to ensure “conditions of safe use.” The conditions of safe use proviso has, however, proven to be a difficult hurdle to overcome, especially in the absence of an alternative category of OTC products —behind-the-counter —that would include an active role for pharmacists as a focal point of control and information provision.

In the U.S., the introduction by the FDA of the Nonprescription Safe Use Regulatory Expansion (NSURE) initiative in 2013 was supposed to spur a new wave of prescription-to-OTC switches, with a focus on creating the conditions for switches in new therapeutic classes. But since 2013 there have been relatively few switches in new OTC therapeutic classes, particularly those in which self-diagnosis may be difficult, or professional monitoring and follow-up deemed necessary.

It’s believed by experts that loss of healthcare professional oversight for products in certain therapeutic categories could lead to missed or inaccurate self-diagnosis, safety issues and the use of inappropriate self-medication.

But this year marks an apparent shift in attitude among regulators, illustrated by three products in therapeutic categories in which OTC products weren’t available. Eroxon isn’t a switched product as it was never prescription-only. But as an OTC therapeutic it belongs in a category—erectile dysfunction—that until now hasn’t been considered in the U.S. as OTC-eligible. Then there’s a spray version of Narcan (naloxone) which the FDA approved as an OTC product a few months ago. This product is used as emergency treatment for opioid overdoses. The FDA made the decision after fast-tracking a prescription-to-OTC switch application from Emergent BioSolutions, the maker of the branded product.

And soon OTC oral contraceptives will likely become a reality. Last month, the FDA advisory committee meeting, a panel of independent experts, voted unanimously 17-0 to recommend that the agency approve the first over-the-counter birth control pill. The Irish firm Perrigo had applied in the U.S. for a switch from prescription-only to OTC status for its once-daily oral contraceptive named Opill. The FDA could reach a final decision on switching the drug to OTC status as early as this summer.

Eroxon’s OTC approval, the switch of a spray version of Narcan and a probable switch of an oral contraceptive indicate a trend of more OTC availability of products in therapeutic classes that weren’t conventionally viewed as OTC.