After hitting a regulatory roadblock in 2022, Sanofi’s consumer healthcare business Opella has secured the FDA’s blessing to move forward with its ambition to convert its erectile dysfunction med Cialis into an over-the-counter product.
The agency previously placed a clinical hold on the company’s planned actual use trial (AUT) for the conversion, citing problems with protocol design. AUTs are a key step in the FDA’s process for switching drugs from prescription to OTC products and are meant to prove that consumers can adequately diagnose and treat themselves without the help of a healthcare provider.
Now, after a review, the FDA’s green light marks a “significant step forward in Opella’s data-driven efforts to switch a PDE-5 inhibitor like Cialis,” Opella’s chief science officer Josephina Fubera, Ph.D., said in a company release.
“We look forward to continuing our work to bring safe and expanded access to the many consumers who will benefit from nonprescription Cialis,” Fubera added.
Prescription Cialis was first approved in 2003 and is marketed by Eli Lilly. In 2014, Lilly inked a licensing agreement with Sanofi that allows the latter company to pursue regulatory approval of OTC Cialis in the U.S., Europe, Canada and Australia.
With the FDA’s permission to go ahead with the AUT study, the drug becomes the first PDE-5 inhibitor to reach this milestone. Drugs in the class, such as Pfizer's Viagra, are typically used to treat erectile dysfunction.
Adding OTC Cialis to Opella’s portfolio would complement its existing portfolio of popular OTC brands such as antihistamine Allegra, non-opioid pain reliever Doliprane, stomach cramp reliever Buscopan and pain treatments Icy Hot and Gold Bond, among others.
While Opella has long operated as a standalone unit within Sanofi, boasting more than 11,000 employees across 100 countries, Sanofi in October proposed a plan to sell a 50% controlling stake to U.S. private equity firm Clayton, Dubilier & Rice (CD&R).
The transaction could close during the second quarter of this year, the company said at the time and will allow the French pharma to hone in on its innovative medicines and vaccines.