Could OTC Cialis for erectile dysfunction reach the US?

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OTC version of Cialis in UK packaging

OTC version of Cialis in UK packaging

Sanofi's consumer healthcare unit Opella could finally be on course to bring an over-the-counter PDE-5 inhibitor for erectile dysfunction to the US market, after the FDA relaxed its clinical hold on a key trial.

The agency placed the hold on a real-world study designed to support the switch of Cialis (tadalafil) from prescription-only to OTC status in 2022 – called an actual use trial (AUT) – citing issues with its design and protocol.

AUTs are used in switching to identify any issues that have not previously been identified and to confirm that consumers can self-diagnose and treat themselves appropriately without the help of a healthcare provider, according to Sanofi.

While OTC versions of Cialis and other PDE-5 inhibitors like Viatris' Viagra (sildenafil) are available without a prescription in other countries they have yet to reach the US market, where currently the only FDA-approved option for men with ED is Haleon/Futura Medical's topical therapy Eroxon.

In a statement this morning, Sanofi confirmed that the FDA has lifted the clinical hold on the AUT, allowing the study to get started and making Cialis "the first PDE-5 inhibitor to achieve this milestone."

The French pharma group has been trying to bring an OTC version to the US market since it licensed rights in Europe, the US, Canada, and Australia from Eli Lilly in 2014, and it was a key product highlighted when the company split consumer health into a standalone business unit in 2019. The OTC version is already available in some markets, including the UK, where it launched in 2023, and Ireland.

Sanofi said last October it was in exclusive talks to sell a 50% stake in Opella to private equity firm Clayton Dubilier & Rice (CD&R) for €16 billion ($16.6.billion). It had previously said it was considering a spin-out or public listing for the business, which reported revenues of €4.1 billion in the first nine months of 2024, up almost 8% on the same period of 2023.

"Now that the FDA has completed their thorough review of our data, we can move into the next phase of this programme; the actual use trial, which is pivotal in ensuring the safety and proper self-selection of Cialis for over-the-counter use," commented Opella's chief science officer, Dr Josephine Fubara.

"We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from non-prescription Cialis," she added.