Nearly nine years after its last attempt to make its blockbuster erectile dysfunction treatment available without a prescription, Pfizer is having another go.
UK regulator the MHRA has began reviewing an application to allow Viagra (sildenafil) to be made available without a prescription if supplied by a pharmacist – a move that would grant it ‘P’, though not OTC (over-the-counter), status.
If approved, Pfizer’s plans would see it continue to market the medicine as a prescription-only treatment under the Viagra brand and then it would provide pharmacists with training on dispensing sildenafil at a 50mg dose.
Pfizer’s UK medical director Dr Berkeley Phillips said: “The availability of pharmacist-supplied, non-prescription sildenafil could offer men a new and additional way to access a legitimate, long established, and well-studied treatment for erectile dysfunction.
“This could have further benefits as the condition may be an early warning sign of a more serious underlying condition, such as heart disease4, which may otherwise go undetected.”
Pfizer has previously tried for European approval to make Viagra available without a prescription, but those plans were scuppered in 2008 after regulatory advisors voiced concerns about misuse of the drug.