The news: Sanofi’s consumer health division, Opella, received the go-ahead from the Food & Drug Administration (FDA) to conduct a study with the goal of converting erectile dysfunction (ED) medication Cialis into an over-the-counter (OTC) product. The study had previously been placed on a clinical hold by the agency.

For context, prescription Cialis was first approved in 2003 and is marketed by Eli Lilly—in 2014, Lilly signed a licensing agreement with Sanofi that permits the latter to pursue regulatory approval of an OTC version in the US, Canada, Europe, and Australia.

What’s driving the about-face? At the time the study was put on hold, the FDA cited problems with protocol design related to the company’s planned actual use trial (AUT). AUTs are a key component of the FDA’s process for converting drugs from prescription to OTC products and are meant to confirm that consumers can self-diagnose and treat themselves appropriately without the help of a healthcare provider.

After a subsequent review of the study, the agency gave the green light to Opella, which can now initiate its AUT.

Why it matters: Cialis is the first PDE-5 inhibitor—a class of drugs that includes the likes of Pfizer’s Viagra—to reach this study milestone.

A shift to OTC status could have serious implications given the number of people impacted by the condition. ED affects about 30 million men in the US, according to the NIH.

Our take: Consumers and direct-to-consumer (D2C) health and wellness retailers stand to benefit should Cialis make the shift from a prescription drug to an OTC product.

Consumers will benefit in the form of increased access to the treatment. OTC status will bypass the need for consumers to see a physician for a Cialis prescription, which some men may have avoided due to feelings of embarrassment. This would likely be welcome news to consumers as they look to increasingly take self-ownership of their health.

And D2C retailers will have another proven product to offer. Companies like Hims & Hers, GoodRx, and Amazon Pharmacy can add Cialis to their roster of OTC health products. OTC medications are consumers’ top health-related online purchase, per our December 2023 survey.

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