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One of the medications men have come to rely on for erection health might be available as an over-the-counter drug within the next three years. At least if French pharmaceutical company, Sanofi, and Eli Lilly and Company’s plans come together.
On May 28, 2014, Eli Lilly announced its plans to sell Cialis as an over-the-counter drug once its patent protection expires for both the U.S. and Europe in 2017.
But it’s not as simple as all that. The makers of Viagra had planned the same OTC sales at one time, but gave up the pursuit in 2008.
If Cialis does make past the rigorous restrictions, new research, and safety concerns, it would be the first drug in its class available without a prescription.
Why Cialis is So Popular
Cialis is one of a handful of prescription medications that effectively treats the symptoms of erection difficulties. These medications are known as PDE5 inhibitors, and they help erections happen more naturally by increasing blood flow to the penis.
With Cialis, there are two ways to take it. You can choose a once-daily tablet, or one that’s effective for 36 hours. The daily use tablets are 2.5 and 5 milligrams per dose. Thirty-six hour Cialis is available in 5, 10, and 20 milligram doses that you can take once, and then forget about for 36 hours.
This flexibility is part of what sets Cialis apart for the men who prefer it over other PDE5 inhibitors.
How a Prescription Medication Become Available Over the Counter
Cialis wouldn’t be the first prescription medication to become available over the counter. There are medications for heartburn, allergies, pain relief, and many other maladies that started off life as a prescription-only drug, and later found their way into the mainstream as over-the-counter medications. But the transition isn’t an easy one.
The FDA says medications that can’t be taken safely unless the patient is under a doctor’s supervision should be available by a prescription, only. The Federal Food, Drug, and Cosmetic Act of 1938 didn’t differentiate between over-the-counter medications and those that could only be obtained with a prescription. But the Durham-Humphrey amendments in 1951 changed that.
The amendments explained that drugs with a higher likelihood of addiction or misuse should be in a separate category, that of a prescription medicine, and all others may be available over the counter.
The process of converting a prescription to an OTC medicine is stringent. Most OTC medications are not as strong as their prescription counterparts for safety reasons. After testing to determine what, if any, is a safe dosage for people who aren’t under a doctor’s supervision, the drug may be reformulated with the lower dose, and then become available without a prescription. But if no such safe dosage is determined, then the FDA can refuse the request, and the medicine will remain prescription only.
Why Viagra Stopped Short, but Cialis Perseveres
In 2008, the quest for OTC approval for Viagra was laid to rest, at least for a while. The European Medicines Agency reportedly raised concerns about its safety without a prescription, and those concerns were reason enough for Pfizer to stop its pursuit, according to the New York Times.
Eli Lilly has a different opinion. David Ricks, President of Lilly Bio-Medicines tells the Times, “We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from E.D. to obtain convenient access to a safe and reliable product without a prescription.”
When the Cialis patent expires, Sanofi plans to buy the rights to seek FDA approval for OTC status in the U.S., Australia, Canada, and Europe. The loss of patent protection means sales could tumble, and fast. Generic versions of Cialis would most certainly arrive on the market, and that competition could take a large share of the market away from the name-brand medication.
Making Cialis available without a prescription requires more than filling out a few forms. The governing bodies that oversee medication safety in each of the proposed countries where it would be sold would have to approve the status. That won’t happen until studies can confirm a dose that’s safe without a doctor’s supervision. Those studies and what they entail would be determined by the FDA.
The Benefits of Cialis Without a Prescription
Erection health is a sensitive topic for most men, especially those who suffer from difficulties achieving and maintaining an erection. Some men suffer needlessly because of the embarrassment involved with having that talk. With Cialis on a drugstore shelf, that conversation never has to happen. More men would have access to the medication they need.
But the opposite side of that coin is the concerns from doctors. Cialis is a PDE5 inhibitor, like the other drugs in its class such as Viagra. These drugs are not safe for men who take nitrates for chest pain.
Without a doctor’s supervision, men may not read the label fully, or may not take the warnings seriously. The risk is a dangerous drop in blood pressure. There are other drug interaction concerns besides nitrates, and also some medical conditions that could make Cialis unsafe for some men.
The studies needed to determine approval for Cialis OTC would address those concerns, and more. If a safe dose can be settled on, then you can expect to see Cialis available without a prescription. If not, it will likely remain available by prescription only.
Without patent protection, Cialis stands to lose a lot of revenue to the generic competition. Bringing Cialis to the over-the-counter market is an ambitious endeavor, and one that’s been attempted before by Viagra. But Eli Lilly might have the determination takes to see it through all of the research and approvals necessary.
Although the Cialis patent expires in 2017, it’s too early yet to say whether an OTC version could be available the same year. But you can still buy the name brand medication that so many men have relied on for erection health from the privacy of your own home.
eDrugstore.com sells Viagra, Levitra, Cialis, Staxyn, and Stendra, which are proven effective for the treatment of erection problems. We offer the privacy and convenience of online ordering, and your discreetly-packed shipment arrives right at your door. If you’re ready to try something that works for erection problems, see what eDrugstore.com has to offer.
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