OTC Viagra Not Ready For Prime Time

Nov 26, 2008

Pfizer’s blockbuster ED drug Viagra might have to wait a little longer before being available over-the-counter in Europe. The drug firm announced last week that it is rescinding its application for OTC status in the wake of comments made by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The EMEA felt that consumers with no erectile dysfunction problems could misuse the treatment as a recreational drug. Patients who suffer from ED as a result of a more serious condition are also less likely to visit a doctor if they can buy the drug directly from a pharmacy.

Pfizer contends that by having a 50mg version of the drug available over the counter, ED sufferers who are embarrassed to seek treatment from a doctor would be more apt to purchase the drug.

“Since its introduction in 1998, there has been ongoing speculation about alternate uses and delivery mechanisms for Viagra,” Pfizer spokesperson Sally Beatty told Pharm Exec on Tuesday. “As with many of our products, Pfizer routinely evaluates ways to improve delivery and formulation to bring the greatest value to patients and healthcare professionals.”

If Viagra had been approved for distribution without a prescription, it would have been the second Rx drug to go OTC in Europe since GlaxoSmithKline’s weight-loss drug Ali. Pfizer says it is open to resubmitting the application at a future date.

“The withdrawal will enable evaluation of further information and additional data that may be required to allow any future assessments under the EMEA centralized procedure,” Beatty said. “We will continue to work with regulators in Europe to improve the availability of our medicines to patients and physicians.”

Viagra has been on the market in Europe since September 1998, available in 25, 50, and 100mg doses.