The US Food and Drug Administration (FDA) has removed the clinical hold on a trial of Cialis (tadalafil) by Sanofi’s consumer healthcare business, Opella.
Opella had launched the actual use trial (AUT) to support its planned switch of Cialis from a prescription to an over-the-counter (OTC) medicine.
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The FDA’s decision makes the erectile dysfunction (ED) tablet the first phosphodiesterase 5 (PDE-5) inhibitor in the US to undergo an AUT.
AUTs are critical in assessing the real-world application of medicines, ensuring that consumers can self-diagnose and self-treat without medical supervision.
The FDA originally placed the trial on hold in 2022 due to concerns over its protocol design.
Opella president and CEO Julie Van Ongevalle said: “We are pleased that the FDA has completed their review and is allowing us to initiate this important study.
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By GlobalData“The actual use trial is not only a significant opportunity to gain insights into how Cialis is used by consumers without a prescription, but it also underscores our commitment to advancing self-care solutions.”
Opella said it is committed to advancing its development programme and providing a new option for self-care with ‘proven effectiveness’ for ED patients.
The company is completing the necessary clinical and regulatory steps to start the pivotal AUT.
Last October, Sanofi and US-based private equity company Clayton, Dubilier & Rice (CD&R) announced plans to transfer a controlling stake of 50% in Opella to CD&R, with Sanofi retaining significant ownership.
As the only available tablet via prescription in the country, Cialis is used to treat ED, benign prostatic hyperplasia symptoms, and both conditions simultaneously.
Earlier this month, Sanofi announced outcomes from its Phase III IRAKLIA trial, which had assessed Sarclisa (isatuximab) as a treatment for multiple myeloma.
The trial met its co-primary endpoints when Sarclisa was administered subcutaneously using an on-body delivery system in combination with pomalidomide and dexamethasone.
