Dive Brief:
- Patients in the U.K. could have a new way to get Pfizer's Viagra (sildenafil) if the British Medicines and Healthcare Products Regulatory Agency opts to make the erectile dysfunction drug available for over-the-counter dispensing in pharmacies.
- The regulator has launched a public consultation on reclassifying Viagra from prescription-only to a pharmacy medicine, asking for comments through April 18.
- This isn't the pharma giant's first go at attempting to win reclassification. An attempt in 2008 fell short after the European Medicines Agency expressed concerns. Even if MHRA makes Viagra available over the counter, Pfizer would continue to supply it as a branded prescription drug as well.
Dive Insight:
Pfizer's Viagra, originally created as a drug for hypertension and angina, celebrates its 20th birthday next year as the first oral erectile dysfunction drug to hit the U.S. market. The drug's sales peaked in 2012 at just over $2 billion, but have been eroded by generic competition and new entrants, dropping to a shade under $1.6 billion in 2016. While Viagra's first generic competitor in the U.S. won't go on sale until December 2017, Actavis launched generic versions in Europe in 2013.
One of the potential challenges for success in erectile dysfunction is men's reluctance to discuss the topic with a doctor, which may be at least partly behind the (rather risky) boom in internet sales of the drug. Online sales are sometimes associated with dubious pharmacies and fake drugs.
Drug availability through pharmacies could be one way to address this issue, and Pfizer suggests pharmacists could also help by alerting patients to other conditions.
The MHRA currently deems Viagra safe enough to made available through pharmacies for adult men with ED, provided the patient is assessed by a pharmacist for potential interactions or when the drug would otherwise not be appropriate.
In a report on the reclassification, the regulatory noted the potential benefits to a more open distribution of Viagra.
"Furthermore [the risk of direct danger is] outweighed by the benefits that this route of supply can bring – by bringing a hard to reach group into healthcare environment with the potential to increase earlier identification of heart disease and also reducing the risks associated with use of counterfeits obtained via the internet," the MHRA wrote in the report.
Pfizer had withdrawn its 2008 reclassification application after recognizing concerns about the proposed supply and pledging to continue evaluation of data.