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Viagra or a generic formulation of the drug could soon become available to U.K. consumers over the counter.
Britain’s Department of Health and the nation’s Medicines and Healthcare Products Regulatory Agency (MHRA) began talks in March 2017 to consider the advisability of selling the popular ED drug without a prescription.
The current deliberations were initiated by a request from Pfizer, the drug’s developer, to have 50-milligram tablets of sildenafil citrate — Viagra’s active ingredient — classified as a nonprescription drug. Pfizer’s patent on Viagra in the United Kingdom and most countries of the European Union expired in mid-2013.
Would Empower Pharmacists
Under the proposal now being considered, pharmacists would be allowed to dispense the drug to patients they deemed appropriate candidates for the medication. Such judgments would be made after a brief discussion with prospective customers about their health and other medications they might be taking.
Although Pfizer’s most recent bid to sell Viagra over the counter would apply only to the United Kingdom, winning approval for such a reclassification there would undoubtedly motivate the drug company to seek similar approvals elsewhere. However, this is not Pfizer’s first attempt to take Viagra over the counter in Europe.
Previous Attempt Made
In mid-2008, roughly five years before its Viagra patent expired in the EU, Pfizer filed an application with the EU’s Committee for Medicinal Products for Human Use (CHMP) to change the marketing authorization for 50-milligram Viagra tablets. Under that proposed change, 50-milligram Viagra’s classification would be changed from “medicinal product subject to medical prescription” to “medicinal product not subject to medical prescription.”
Nearly five months after filing its application with the CHMP, an arm of the European Medicines Agency, Pfizer withdrew the request. Although the drugmaker had submitted answers to a host of questions from the CHMP, the agency said it still had concerns about the advisability of reclassifying Viagra from prescription to nonprescription.
Underlying Health Problems
At the heart of the CHMP’s concerns was the fear that men whose erectile dysfunction was itself a symptom of more serious underlying illness might avoid having such health problems addressed by selling Viagra over the counter. Most ED stems from insufficient blood flow to the penis, which can be caused by atherosclerosis or other earlier manifestations of cardiovascular disease, as well as diabetes, obstructive sleep apnea, and intractable high blood pressure.
CHMP also worried that the instructional information that Pfizer proposed to package with the OTC product was too complicated to be fully understood by the average consumer. The agency also voiced concern that making the ED drug more readily available to the public might encourage recreational use of the medication by younger users.
Application Covers Only UK
Obviously, the current U.K. application to market Viagra over the counter is separate and distinct from the earlier EU petition. However, by giving pharmacists greater authority to decide who should get the drug, Pfizer hopes to overcome some of the concerns expressed earlier by the CHMP.
As previously noted, Pfizer’s patent on Viagra expired in 2013 in the United Kingdom and most other countries of the European Union. As a result of the U.K. voters’ decision to withdraw from the EU — the so-called Brexit vote — regulatory authority over prescription drugs in the U.K. is now the province of U.K.-based agencies and not the European Medicines Agency.
Other Changes Loom
Whether Pfizer will win U.K. approval for its bid to market Viagra over the counter remains to be seen. But other changes are coming for the little blue pill, which first debuted in the late 1990s. While generic formulations of Viagra are sold in a number of countries where Pfizer’s patent on the drug has already expired, that patent remains valid in the United States until April 2020.
However, under the terms of a court-supervised agreement between Pfizer and Teva Pharmaceuticals, the latter will be free to begin selling a generic version of Viagra in the United States in December 2017. Because Pfizer’s patent will still be in force, Teva will be required to pay a royalty to Pfizer for the right to market the generic version.
First Generic ED Drug in US
As things now stand, Teva’s generic version of Viagra will be the first generic formulation of a brand-name ED drug to be sold to U.S. consumers. However, because the patents on Cialis and Levitra are due to expire later this year or next year, generic versions of those drugs will come to market within the foreseeable future.
The advent of generic competition to the brand-name ED drugs will exert downward pressure on the prices of ED drugs, many of which are currently too expensive for some U.S. consumers to afford. So while the prices for these drugs are certain to drop to more reasonable levels, it’s likely that the number of potential consumers for these drugs will expand.
Cialis Could Go OTC
Yet another major development in the ED drug market could come later this year or early in 2018 if French drugmaker Sanofi wins FDA approval to market an over-the-counter formulation of Cialis (tadalafil). Eli Lilly & Company, which holds the patent on Cialis, and Sanofi in 2014 announced an agreement under which Sanofi was granted exclusive rights to seek regulatory approval to sell Cialis OTC in Australia, Canada, Europe, and the United States.
A recent review of new drug applications on file with the FDA indicate that Sanofi has not yet submitted an NDA for the sale of tadalafil, the active ingredient in Cialis, over the counter.
Family of Medications
Viagra, the first of the impotence drugs to be introduced, was followed to market by Levitra, Cialis, Staxyn, and Stendra. All of these drugs belong to a family of medications known as PDE5 inhibitors, so called because they temporarily disable the phosphodiesterase-5 enzyme, which can interfere with blood flow to the penis.
While these drugs differ slightly in chemical structure, they all work in much the same way.
Their most common side effects are generally mild and may disappear altogether upon continued use. Such side effects include back pain, dizziness, flushing, headache, indigestion, and runny or stuffy nose. Although rare, more serious side effects include a sudden loss of hearing or vision or an erection that lasts more than four hours. If you should experience these more serious side effects, seek medical attention immediately.
Men who are taking nitrate-based drugs to treat angina or intractable high blood pressure should not take PDE5 inhibitors. Both of these types of medication sharply reduce blood pressure. Taken together, they could cause a potentially life-threatening drop in blood pressure.
Prescription Required for Now
Although things could change by late 2017 or early 2018, the only ED drugs legally available to American men at the moment are prescription-only brand-name medications. If you would like to order Viagra or one of the other ED drugs online, consider placing your order through eDrugstore.com, which sells only FDA-approved medications that are sourced from licensed U.S. pharmacies.
If you already have a prescription from your doctor, you can fax or scan and email it along with your order. If you don’t have a prescription, eDrugstore can arrange a complimentary consultation with one of its team of licensed physicians. You will be asked to fill out a questionnaire detailing your symptoms and medical history and listing all medications you are now taking. If the doctor you’re assigned deems it appropriate, he or she will authorize a prescription.
To learn more about the medications that are currently available and possibly place an order, click below to access eDrugstore’s Male Impotence Page.
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