Over-the-counter Viagra bid ends
pharmafile | November 21, 2008 | News story | Sales and Marketing |Â Â ED, OTC, viagraÂ
Plans to make Viagra available through pharmacies in Europe without a prescription have been scuppered by safety concerns.
Pfizer has ended its bid to make the drug a non-prescription drug after the regulator the EMEA said this could lead to misuse, and prevent underlying health problems in men from being detected.
The regulators medicines committee the CHMP said that Viagra is safe when users follow prescribing guidance, but said a lack of medical supervision could mean health problems, such as cardiovascular disease, could go undiagnosed.
The committee also voiced concerns about complicated product information for patients, which it believed could lead to misuse, and said its wider availability would also encourage its recreational use.
Viagra was launched ten years ago, and has been used by more than 35 million men worldwide.
The move towards non-prescription status would be hugely lucrative for Pfizer, and help protect its revenues as the drug approaches its patent expiry.
It had been hoped the move might help reduce demand for the drug through illegal channels, such as unregulated internet pharmacies, which often supply counterfeit medicines.
Despite the setback, Pfizer has not ruled out a second attempt at OTC approval.
"Viagra has a proven safety profile that has been well established in extensive post-marketing studies and in more than 120 clinical trials," said Rory OConnor, Pfizer vice president of Medical and Regulatory Affairs. "We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians and the benefits they get from our therapies."
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