Tadalafil switch from Rx to OTC: USFDA puts a clinical hold on Sanofi's Trial
Paris: Sanofi has announced that U.S. Food and Drug Administration (USFDA) has placed clinical hold on its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil).
"The U.S. Food and Drug Administration has informed Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design." the company said in a release.
Sanofi's AUT has not yet recruited any patients.
"Sanofi continues to work with FDA to move the Cialis program forward and will engage the Agency in upcoming meetings as we determine next steps," the company added.
Currently only available with a prescription, Cialis is a tablet taken to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH. Cialis is the only PDE-5 inhibitor treatment that offers men a choice when it comes to treatment for erectile dysfunction - Cialis for use as needed and Cialis for once daily use.
Tadalafil is a selective phosphodiesterase-5 inhibitor that is used in the treatment of erectile dysfunction (ED), pulmonary arterial hypertension (PAH), and benign prostatic hypertrophy. It was first approved in 2003 by the FDA for use in ED and later in 2009 for PAH. In contrast to other PDE5 inhibitors like sildenafil, tadalafil has greater selectivity for PDE5 and a longer half-life which has made it a more suitable option for chronic once-daily dosing in the treatment of PAH.
Tadalafil selectively inhibits the cyclic guanosine monophosphate (cGMP)-specific type 5 phosphodiesterase-(PDE-5)-mediated degradation of cGMP, which is found in the smooth muscles of the corpus carvenosa and corpus spongiosum of penis. Inhibition of cGMP degradation by tadalafil results in prolonged muscle relaxation, vasodilation, and blood enforcement of corpus cavernosa and so prolongation penile erection.
