The reclassification will change the drug’s status from prescription only medicine (POM) to pharmacy medicine (P), meaning that if marketed, the medicine will be sold following a discussion with a pharmacist, said the Medicines and Healthcare products Regulatory Agency (MHRA) in a statement.
Viagra or Viagra Connect?
The prescription version of sildenafil, marketed by Pfizer as Viagra, is indicated for the treatment of the symptoms of erectile dysfunction in adult men (aged 18 years and over). It is available in 25mg, 50mg and 100mg tablets.
Viagra Connect, the non-prescription, pharmacy-supplied version of sildenafil 50mg, is indicated for erectile dysfunction in adult men (aged 18 years and over). It is available in 50mg tablets.
Pfizer has been making the active pharmaceutical ingredient (API) for Viagra at its Rigaskiddy facility in Ireland, but spokesperson Lisa O’Neil told us Viagra Connect will be manufactured in France.
“Pfizer will be investing in start-up costs to deliver Viagra Connect to the UK market and resulting investment will be made in manufacturing based on demand,” she said.
The reclassification responds to an application made by the drugmaker, said O’Neill.
This was confirmed by an MHRA spokesperson:“The company presented information to support its view that Viagra Connect 50mg tablets are suitable to be switched to Pharmacy status.”
Pharmacists will not sell Viagra Connect to those with severe cardiovascular disorders, liver failure, severe kidney failure, or patients taking certain interacting medicines.
“Use of Viagra Connect in these groups of men must continue to be under the supervision of a doctor,” the MHRA told us.
The MHRA announced it has seized more than £50m ($67m) of unlicensed and counterfeit erectile dysfunction medicines over the past five years, however according to the spokesperson, the decision to reclassify Viagra Connect is unrelated.
“Erectile dysfunction medicines are a popular target for criminals selling unlicensed and counterfeit medicines,” he told us.
“It’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side effects,” he added.