Viagra Connect hits UK shelves
This article was originally published in OTC Bulletin & The Rose Sheet
Pfizer is preparing a wide-ranging consumer marketing campaign to support the launch of its Viagra Connect (50mg sildenafil) product in the UK, after the country’s first OTC medicine for erectile dysfunction hit the shelves yesterday.
Available exclusively through Boots pharmacies and Boots.com for a two week period which ended on 10th April, Viagra Connect – which was approved as a pharmacy medicine late last year (OTC bulletin, 15 December 2017, page 1) – is now available in pharmacies across the UK.
Boots is currently selling a four-tablet pack of Viagra Connect for £19.99 (€22.82) and an eight-tablet pack for £34.99.
Viagra Connect is available to UK men aged 18 years or older suffering from erectile dysfunction. Pfizer has produced a checklist for pharmacists to use when supplying the product to determine a man’s suitability.
A spokesperson for Pfizer UK told OTC bulletin that the consumer launch of Viagra Connect would be backed by a “carefully planned” and wide-ranging marketing programme, which included television, outdoor and print advertising.
Digital and social media activities would also play a key role in informing consumers that the product was available without a prescription, the spokesperson added, with further support coming in the form of in-store promotional materials, along with public relations and consumer education campaigns.
“Our marketing and advertising activities have been designed based on detailed insights from men with erectile dysfunction,” the spokesperson pointed out, “about how the condition made them think and feel, and the positive change they experienced when they took the steps to get help and seek treatment.”
“We have committed a great deal of time, effort and resource into making all the marketing material as relevant and helpful to the audience as possible,” the spokesperson added.
Commenting in December on why Pfizer’s switch application for Viagra Connect had been successful, the Medicines and Healthcare products Regulatory Agency (MHRA) pointed out that the product had received a positive feedback from the UK’s Commission on Human Medicines and had a safety profile which was “reassuring”.
Furthermore, the agency explained, only a pharmacist could sell the product and decided whether treatment was appropriate for the patient. Pharmacists were uniquely positioned, it continued, to give advice on erectile dysfunction, usage of the medicine, potential side effects, and if a further consultation with a general practitioner was required. The use of the pharmacist checklist, in combination with a pharmacist’s professional judgement, would, the MHRA insisted, “minimise the risks of indirect danger arising from missed diagnosis of underlying disease”. “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,” the regulator added.
Making Viagra Connect available without a prescription would “help direct men who might not otherwise seek help into the healthcare system”, the MHRA claimed, “and away from the risks that come with buying medicines from websites operating illegally”.
Erectile dysfunction medicines were a popular target for criminals selling unlicensed and counterfeit medicines, especially online, the agency noted.
According to market research firm Euromonitor International, the approval of Viagra Connect will provide a significant boost to the UK OTC market and has the potential to trigger similar switches in other countries. Kenna Roberts, Euromonitor’s consumer health analyst, told OTC bulletin at the time that the switch was approved that the reclassification of sildenafil in the UK was the “most significant switch in recent memory” and represented a “major disruption to the global OTC market”.
“Euromonitor estimates that in the first year of the drug’s availability OTC, it is likely to generate more than double the sales of the whole of the Cough, Cold, and Allergy Remedies (CCA) category,” Roberts insisted, “which currently occupies the top spot in OTC sales at £726 million (€826 million) in 2016.”
“Even more important than the changes the switch will bring to the UK market, is the domino effect that is likely to occur as other major markets consider whether to make Viagra available OTC,” Roberts claimed. “In the US, prescriptions for erectile dysfunction drugs have fallen in recent years as the pills have become increasingly unaffordable, but this decrease in sales would be easily reversed if Viagra were switched to OTC status and would likely be the most significant disruptor to the OTC space the US has ever seen.”
The UK is now the second major market to allow OTC access to sildenafil.
In May 2016, Poland allowed men to buy sildenafil without a prescription after the country’s medicines regulator approved an application by Adamed to sell OTC its MaxOn Active sildenafil product, but at the lower strength of 25mg (OTC bulletin, 27 May 2016, page 1).
Prior to the ‘true’ prescription-to-OTC switch of sildenafil in Poland, New Zealand had come closest to granting OTC status. Sildenafil, however, remains partially restricted in the country. It is still a prescription medicine “except when supplied by a pharmacist who has successfully completed the approved training programme for the treatment of erectile dysfunction in males aged 35 to 70 years” (OTC bulletin, 24 October 2015, page 1).
Pfizer tried and failed to switch sildenafil through the European Union’s (EU’s) centralised procedure in 2008 (OTC bulletin, 28 November 2008, page 1).
The US firm withdrew its Viagra application in the EU following “some concerns” – including a lack of medical supervision, potential for unintentional misuse and possible abuse of the drug for recreational purposes – at the European Medicines Agency (EMA).