The company that manufactures the popular erectile dysfunction drug Cialis is looking to get the Food and Drug Administration's approval to sell the drug over-the-counter in a move aimed at stemming the increasing number of black market sellers of the ED drug.
The move, however, according to reports, is a major "what if" for the company and the potential of selling the drug without prescription.
Sanofi and Eli Lilly, two drugmakers who offer the drug aimed at helping men who are impotent or struggling in the bedroom, would be the first able to get the drugs on the market for purchase without a prescription.
The drug was approved by the FDA in 2003 for prescription-only usage, and until now, the idea of moving it to OTC status has not really been in the forefront of the sector's mind. But the end of patent protection and rise in black market sales of the drug, which is also used to treat enlarged prostates, could have been a major tipping point to getting into the over-the-counter sales market.
Lilly spokesperson Celeste Stanly was quoted as saying the company does not expect, even with FDA approval, to have a nonprescription counter version ready to roll out until 2018.
That would be vital for companies selling Cialis, specifically, as the patent protection runs out in 2017, meaning that generics would then be allowed onto the market, a development which could give the industry another boost.
"Half of [American] men over 40 suffer ED," said Dave Ricks, senior VP at Lilly. "But the current market [for prescription ED drugs] only represents a fraction [of potential patients]. Men don't want to go through the hassle and sometimes discussions with doctors. There is a need to self-diagnose. We think that (over-the-counter) availability is key to helping guys" with impotence.
Cialis, and its predecessor Viagra, have largely dominated the ED business over the past decade, with advertisements regularly gracing television screens.
The FDA has not spoken publicly on the possibility of Cialis losing its prescription-only status, and it is unclear whether the agency would be more likely or less likely to approve the drug for wider dissemination.
But as prescription drugs become ever more expensive for the average American as health-care costs soar, Ricks and the companies behind Cialis believe that by dropping the need for a prescription, it can reach a larger number of men who need it.
