Sanofi: clinical suspension lifted for Cialis trial
(CercleFinance.com) - Opella announces that the US FDA has lifted the clinical suspension on the real-life trial it intends to conduct in support of its application to transfer Cialis to the self-medication market.
This decision allows the launch of this trial, and makes Cialis the first PDE-5 inhibitor to be studied for over-the-counter marketing, Sanofi's consumer healthcare business says.
The aim of the real-life trials is to identify any as yet undetected problems, and to confirm that consumers can self-diagnose and self-treat adequately without the intervention of a healthcare professional.
Opella is in the process of completing the clinical and regulatory formalities required to launch this pivotal trial under real-life conditions. Information on this study will shortly be available on the clinicaltrials.gov website.
Copyright (c) 2025 CercleFinance.com. All rights reserved.
This decision allows the launch of this trial, and makes Cialis the first PDE-5 inhibitor to be studied for over-the-counter marketing, Sanofi's consumer healthcare business says.
The aim of the real-life trials is to identify any as yet undetected problems, and to confirm that consumers can self-diagnose and self-treat adequately without the intervention of a healthcare professional.
Opella is in the process of completing the clinical and regulatory formalities required to launch this pivotal trial under real-life conditions. Information on this study will shortly be available on the clinicaltrials.gov website.
Copyright (c) 2025 CercleFinance.com. All rights reserved.