Sanofi’s plans for OTC Cialis hit a snag in the US –

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It’s been eight years since Sanofi cleared the rights to an over-the-counter version of Eli Lilly’s erectile dysfunction (ED) drug Cialis, and the FDA just threw the brakes on its plans to market it in the United States.

Sanofi said this morning that the US regulator had imposed a clinical hold on its real-use trial (TUE) of the OTC formulation over “issues surrounding protocol design.”

According to the French pharmaceutical group, the study has not yet recruited patients, and it “will engage the agency in future meetings as we determine the next steps”.

Cialis (tadalafil) is sold as a prescription-only treatment worldwide for erectile dysfunction and was first approved for marketing in 2002, reaching sales of $2.3 billion for Lilly in 2015 before the expiration of its patents in the United States and generic copies of the drug and rival therapy. Pfizer’s viagra (sildenafil) has eroded market share.

Sanofi bought the rights to an OTC version in Europe, the United States, Canada and Australia in 2014, saying it would market the new version after patents on the drug expired. The terms of this license agreement were not disclosed.

At the moment, there are no OTC ED drugs available in the US, although Pfizer launched an OTC version of its drug – called Viagra Connect – in select markets starting with the UK in 2017. It There were no announced plans to bring the product to the US market, although Viagra retained patent protection there until 2020.

In her first quarter earnings update, Sanofi’s head of consumer health – Julie Van Ongevalle – said the switch to Cialis in the US had been delayed by the pandemic, but added that she is expected the AUT trial to start before the end of the second quarter.

“No company has gone this far on this journey, and that puts our estimated launch date in 2025,” she pointed out.

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