Change of product class – Tadalafil MAXON

Adamed Pharma, a Polish pharmaceutical company, is the first one ever that has been  granted a marketing authorisation for over-the-counter tadalafil.

The President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued a decision to reclassify medicinal product Tadalafil MAXON from the Rx category to OTC. The reclassification decision came into force on 01.02.2022. Tadalafil is, next to sildenafil, the PDE-5 inhibitor helping erectile dysfunction (ED) treatment. Comparing to sildenafil, it has longer time of action (works up to 36 hours). What is more, its work is influenced neither by food nor alcohol.

In 2019, Adamed initiated a multi-centre intervention clinical trial of tadalafil 10 mg including 408 participants. The purpose of the trial was to demonstrate that patients can safely use tadalafil at a dose of 10 mg on their own. The trial results unambiguously indicate that a patient is able to make an independent and safe decision on the possibility to use tadalafil at a specific dose without consulting the doctor, with the use of a dedicated diagnostic tool.