Sanofi says OTC Cialis could help tackle fakes

Sanofi has signed a deal with Eli Lilly to develop an over-the-counter (OTC) version of its erectile dysfunction (ED) drug Cialis.

With prescription-only ED drugs such as Cialis (tadalafil), Pfizer's Viagra (sildenafil) and Bayer/GlaxoSmithKline's Levitra (vardenafil) among the most counterfeited medicines around the world, having an OTC product for ED available could reduce demand for falsified copies.

One reason why falsification of Cialis and its peers is so rampant is that men are sometimes reluctant to broach the subject of ED with their doctor and get a prescription for therapy, while others just find it easier to bypass the doctor and order the drugs directly online. Unfortunately, that exposes them to the risks of receiving counterfeits that are either useless or potentially harmful.

A Pfizer-commissioned survey in 2011 found that men were still placing themselves at risk of counterfeits - such as buying ED medicines from Internet pharmacies advertised by spam (27 per cent) or based on an online search (36 per cent) - despite public awareness drives to highlight the dangers of buying drugs from rogue pharmacies.

Meanwhile, a survey conducted by the National Association of Boards of Pharmacy in the US found that 97 per cent of websites selling prescription drugs were not legitimate pharmacies, while around half offered foreign or non-FDA-approved drugs.

Cialis was first approved in the EU in 2002, followed by the US in 2003, and brought in almost $2.2bn in sales last year. If approved the OTC version will only be launched once patents on the prescription-only brand have expired, according to Sanofi. Cialis is due to lose patent protection in 2017.

It remains to be seen whether Sanofi will be successful in switching Cialis from prescription-only to OTC status. An earlier attempt by Pfizer to get the go-ahead for OTC Viagra was abandoned in 2008 after regulators in Europe expressed concerns over its safety.

At the time, Pfizer estimated that a third of all men seeking treatment for ED sought to source Viagra outside formal healthcare channels.