FDA pushes to pause trial for over-the-counter version of anti-impotence drug Cialis

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Sanofi logo at the company headquarters during the annual results news conference in Paris, France, February 4, 2022. REUTERS/Benoit Tessier/File Photo

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PARIS/LONDON, May 30 (Reuters) – The U.S. health regulator has suspended a trial to assess the switch from prescription erectile dysfunction drug Cialis to an over-the-counter (OTC) treatment, French drugmaker Sanofi (SASY.PA) said Monday.

The pause is linked to concerns about the way the trial protocol was designed, the company said, adding that no patients had so far been recruited for the study.

Cialis, known chemically as tadalafil, was first approved by the European Medicines Agency in 2002 and then by the United States Food and Drug Administration (FDA) in 2003 as a prescription-only treatment .

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The treatment – which earned US drug developer Eli Lilly (LLY.N) billions before generic competition eroded sales – has differentiated itself from the competition because it has a time-release formula that allows men to take it anywhere up to 36 hours before using it. .

In 2014, Sanofi obtained the license to sell Cialis as a non-prescription drug in the United States, Europe, Canada and Australia, once regulatory approvals were obtained in each region.

This OTC version of Cialis is expected to be a key contributor to achieving above-market growth from 2024 in Sanofi’s consumer healthcare division, a company executive said last year.

Any delay here is clearly unnecessary, Bernstein analyst Wimal Kapadia told Reuters, adding that it was unclear what the delay would mean for this 2024 timeline.

Sanofi shares were down more than 3% late Monday morning.

When determining whether to allow prescription drugs to be sold over-the-counter, the FDA assesses whether patients are able to understand complex aspects of their condition and exactly when to take the drug to ensure safe use.

Like rival anti-impotence drugs, such as Viagra, Cialis can cause a dangerous drop in blood pressure if taken with nitrates, a class of heart medications that includes nitroglycerin.

The global erectile dysfunction treatment market was estimated at around $3.7 billion last year and is expected to reach around $5.9 billion by 2028, according to market intelligence firm Coherant Market. Insights, although it is unclear what slice of the market should be taken by over-the-counter drugs.

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Reporting by Tassilo Hummel in Paris and Natalie Grover in London; additional reporting by Juliette Portala in Gdansk; Editing by Bradley Perrett and David Holmes

Our standards: The Thomson Reuters Trust Principles.

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