Cialis is a PDE-5 inhibitor therapy that can be used 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 an anti-impotence drug developed by Sanofi. (Credit: James Yarema on Unsplash)
Sanofi announced that the US Food and Drug Administration (FDA) has put on hold, its planned Actual Use Trial (AUT) of its erectile dysfunction drug Cialis (tadalafil), over concerns related to the protocol design of the trial.
AUT was designed to evaluate the possible switching of Cialis usage from its current prescription-only indication to an over-the-counter (OTC) treatment.
Sanofi stated that the trial has not recruited any patients and will work together with FDA to advance the Cialis programme and will join the agency in future meetings.
Cialis is a PDE-5 inhibitor therapy that provides a treatment option for erectile dysfunction in men, used as needed and for once daily use.
The drug can be used 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 was first approved by the European Medicines Agency (EMA) in 2002, followed by the US FDA in 2003, as a prescription-only therapy.
In 2014, Sanofi has obtained the license to commercialise Cialis as a non-prescription drug in the US, Europe, Canada and Australia, after receiving regulatory approvals.
Sanofi, in a statement, said: “Cialis is not for women or children. It is important to note that Cialis is not to be taken with medicines called “nitrates” such as isosorbide dinitrate or isosorbide mononitrate which are often prescribed for chest pain; or with recreational drugs called “poppers” like amyl or butyl nitrite, as the combination may cause an unsafe drop in blood pressure; or if allergic to Cialis or Adcirca (tadalafil), or any of its ingredients.
“Anyone who experiences any symptoms of an allergic reaction, such as rash, hives, swelling of the lips, tongue or throat, or difficulty breathing or swallowing, should call a healthcare provider or get help right away.”
The US FDA considers the ability of patients to understand complex aspects of their condition and exactly when to take the drug, while allowing prescription drugs to be sold over the counter, Reuters reported.