Dive Brief:
- The U.K. drugs regulator has reclassified Pfizer Inc.'s erectile dysfunction drug Viagra as a non-prescription medicine, making the U.K. the first country where the drug can be bought over the counter.
- Viagra Connect, as the OTC version will be marketed, now has pharmacy status, meaning it can be sold without a prescription after a discussion with a pharmacist.
- Pfizer plans to launch Viagra Connect next spring, and is putting together a training and education program for pharmacies.
Dive Insight:
Dubbed the little blue pill, Pfizer's Viagra (sildenafil) was the first oral treatment approved to treat erectile dysfunction and has since been credited for increasing awareness and reducing stigma for the condition. National Health Service prescriptions for sildenafil rose by 43% between 2014 and 2015, and by 16% between 2015 and 2016, to 2,958,199, as reported by the U.K.'s The Guardian.
Drugs in the UK are classified into three categories: Prescription-only medicine; pharmacy (can be sold over-the-counter in pharmacies); or general sales list (can be sold in retail stores, such as supermarkets). Viagra Connect is the first erectile dysfunction drug to gain pharmacy status in the UK.
Viagra Connect will be sold as a 50 mg tablet only; the prescription drug will remain available as 25, 50 and 100 mg tablets.
Attempts to move Viagra to over-the-counter status failed in 2008, but the process began again with a public consultation launched in March 2017. "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," noted the U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA).
One factor behind the MHRA's approval is the sheer volume of counterfeit Viagra shipped and sold. The ED treatment is the most commonly counterfeited drug available online, according to a report from CNN.
"Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines," stated the MHRA. "Over the past 5 years, investigators from MHRA have seized more than £50 million [$67.2 million] of unlicensed and counterfeit erectile dysfunction medicines."
Counterfeit drugs typically have higher risk and can come with off-target effects or other safety issues.
Selling Viagra over the country could give Pfizer another channel for demand in Europe. Sales of the drug outside of the U.S. and Canada fell 30% year over year in the third quarter of 2017, as generic competition eats into revenues from Europe.
The first generic version of the drug will reach the U.S. market next month, courtesy of Teva. Already, Pfizer has seen wholesalers destock ahead of generic entry.