SANOFI: FDA SUSPENDS TRIAL OF OTC VERSION OF CIALIS
PARIS (Archyde.com) – Sanofi announced on Monday that the Food and Drug Administration (FDA), the American health authority, has postponed the launch of the trial in real conditions of use of Cialis, a treatment against disorders of the erection, aiming to achieve over-the-counter drug status.
“Sanofi continues to work with the FDA to advance the Cialis transfer program into the self-medication market,” the French drugmaker said, adding that next steps would be determined in upcoming meetings.
Sanofi said it had not recruited patients for the trial.
The title of the pharmaceutical group lost 3.4% at 8:30 GMT at the Paris Stock Exchange.
An analyst contacted by Archyde.com pointed to low market expectations as the reason for the stock move, but added that the trial was meant to boost sales of the group’s consumer healthcare division if successful.
“It is a bit surprising to suspend a trial before it begins, especially since the protocol is generally agreed in advance”, also underlines the analyst in an email.
Cialis, whose active agent is known as Tadalafil, was first approved by the European Medicines Agency in 2002 and then by the US FDA in 2003, by prescription only.
Sanofi, together with drug owner Eli Lilly, has been seeking regulatory approval for a non-prescription version of Cialis since 2014.
Cialis made $718.4 million (668.28 million euros) for Eli Lilly last year, according to the company’s annual report.
(Report by Tassilo Hummel; French version by Augustin Turpin, edited by Kate Entringer)