Some examples of popular drugs that used to be sold by prescription only, but were later approved for OTC sales are Allegra, Prevacid, Rogaine, and Children’s Advil.
On May 28, French pharmaceutical company Sanofi, along with Eli Lilly and Company, announced that they were pursuing regulatory approval of nonprescription Cialis, which is currently only available with a prescription. Cialis is one of the most popular drugs in the world, used by an estimated 45 million men for treatment of erectile dysfunction (ED).
The agreement between Sanofi and Eli Lilly gives Sanofi exclusive rights to apply for approval of Cialis OTC in the US, Europea, Canada, and Australia. If approved, Sanofi will also have exclusive marketing rights to Cialis OTC. If approval is granted, the drug will be made available after the expiration of “certain patents,” according to the press release announcing the venture. The patents for Cialis in the US and Europe expires in 2017.
How Cialis Differs from other ED Medications
Cialis belongs to a class of ED medications called PDE-5 inhibitors. Other drugs in this class include Levitra and Viagra. However, the formulations of these drugs differ. Cialis is known (and marketed) for its longer half-life. Some men take Cialis and find that it remains effective for up to 36 hours, compared to 4 to 6 hours for Viagra and Levitra. Furthermore, Cialis may either be taken on an as-needed basis, or as a once-daily therapy. The drug is also used to treat the symptoms of benign prostatic hyperplasia (BPH).
Why Eli Lilly and Sanofi Are Pursuing OTC Status
Introduced in 2003, Cialis had $2.16 billion in worldwide sales in 2013, with total global sales of $14 billion since its launch. When US and European patent protection on Cialis runs out in 2017, sales are expected to drop considerably once cheaper generic versions are introduced. But if Cialis is approved for sale over the counter, it could gain a major advantage over competitors. It’s not uncommon for drug companies to seek approval to move popular prescription drugs to over-the-counter status as a way to hold onto sales once the prescription product loses patent protection.
Benefits for Men
Sanofi also has its eye on another potential driver of sales of Cialis over the counter: men who have been purchasing “Viagra” from shady online dealers – pills which all too often turn out to be fake. If men know they can obtain Cialis over the counter without visiting a physician first, they may be less likely to turn to questionable online sources that may or may not be selling a safe product.
In a consumer healthcare conference in London earlier in June, Vincent Warnery, Senior Vice President of global Consumer Health Care at Sanofi, said, “The vast majority of men don’t consult their doctor on erectile dysfunction. Men search online for drugs they can access directly and in doing so, they expose themselves to the huge risks of counterfeit drugs.” Last year, in its own effort to put a dent into counterfeit Viagra sales, Pfizer began selling Viagra directly to consumers through the company’s website. The move to OTC status by Cialis is another way of removing hurdles to treatment that can drive men to buy from disreputable sources.
Though there hasn’t been much in the way of strong opposition to making Cialis available over the counter, one urologist, Johns Hopkins School of Medicine’s Dr. Kevin L. Billups, has expressed concern. Erectile dysfunction in some cases is an early warning sign for heart disease and diabetes. “Maybe you’re missing an opportunity to pick up something else,” Dr. Billups told The New York Times.
Approval for OTC Viagra Has Been Tried
Sanofi will have to follow approval steps similar to those tried by Pfizer in 2007, when it tried to gain approval for an OTC version of Viagra in Europe. At that time, the European Union’s drug regulator raised concerns, and Pfizer withdrew its application in 2008. Part of Sanofi’s strategy will include analyzing why Pfizer’s OTC application for Viagra in Europe was unsuccessful.
Some consumer healthcare specialists say they wouldn’t be surprised if Pfizer made another attempt to take Viagra over the counter in response to Sanofi’s plan with Cialis. Pfizer hasn’t said much about the possibility, though Pfizer spokesperson Sally Beatty, did say the company was “evaluating a number of prescription drugs for potential switch to non-prescription status, and are focusing on categories that will have the greatest positive impact to people and the healthcare system overall.”
How the FDA Approves New OTC Drugs
When the US Food and Drug Administration (FDA) determines whether to allow prescription drugs to be sold over the counter, they weigh consumers’ ability to understand complex aspects of their health condition and when and how to take the drug safely. In 2008, for example, the FDA rejected Merck’s bid to sell the cholesterol lowering drug Mevacor over the counter because an independent panel of medical experts stated concerns about patients using it rather than newer, more effective medications.
To gain OTC status for Cialis, Sanofi will have to show drug regulators that men can correctly determine whether to take the drug and use it safely without the guidance of a physician. In some men taking particular heart and blood pressure medications, taking Cialis can cause a sudden, dangerous drop in blood pressure, and the FDA will undoubtedly spend time and attention determining how big a risk over-the-counter Cialis would pose to the average man. The option of being able to buy Cialis over the counter will likely be greeted with enthusiasm by men coping with ED, because it will make getting treatment for the condition significantly easier.
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