UK first country to allow OTC sales of erectile dysfunction drug Viagra

UK first country to allow OTC sales of erectile dysfunction drug Viagra

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today announced Viagra Connect (containing sildenafil 5mg) will be formally classified from a prescription-only medicine (POM) to a pharmacy medicine (P). This means it could be available without prescription for use by men over 18 who have erectile dysfunction.

Силденафил

This decision was made following a reassuring assessment of the safety of the Viagra Connect, advice from the Commission on Human Medicines, and a public consultation earlier this year with positive outcome, and makes the UK the first country to permit over-the-counter sales of the therapy.

Launch planned for spring 2018

Viagra maker Pfizer (NYSE: PFE) says it is currently working on plans for the launch of Viagra Connect in the UK in the spring of 2018. In the interim, the company will be implementing an extensive training and education program within pharmacies. When available, supply of the product will depend on pharmacists’ assessment of its suitability for each man presenting with symptoms of erectile dysfunction (ED).

Sildenafil is already available on National Health Service (NHS) prescription free of charge. Pfizer has not indicated a likely retail price for OTC Viagra, which achieved peak worldwide sales of more than $2 billion in 2012 but sales have since declined as patents have expired, prompting Pfizer to explore extending its brand value as a non-prescription drug.

If marketed, the medicine will be sold from pharmacies following a discussion with the pharmacist. Viagra Connect will not be sold to those with severe cardiovascular disorders; at high cardiovascular risk; liver failure; severe kidney failure; or taking certain interacting medicines. Use of Viagra Connect in these groups of men must continue to be under the supervision of a doctor.

Making this medication more widely available will help direct men who might not otherwise seek help into the healthcare system and away from the risks that come with buying medicines from websites operating illegally, the MHRA pointed out.

Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines. Over the past five years, investigators from MHRA have seized more than £50 million ($66 million) of unlicensed and counterfeit erectile dysfunction medicines.

29-11-2017

https://www.thepharmaletter.com/

November 29, 2017 / Pharma News