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A licensing deal between two pharmaceutical giants has laid the groundwork for the introduction of an over-the-counter version of the popular impotence drug Cialis in the United States, Europe, Canada, and Australia.
But don’t start scanning the shelves at your local pharmacy any time soon for Cialis OTC — the over-the-counter version’s proposed brand name. Under the terms of the agreement, Cialis OTC won’t be available until 2017 or 2018 when the drug’s patents expire. And only then if the drug’s OTC version manages to win the approval of the Food and Drug Administration in the United States and other regulatory agencies abroad.
Lilly-Sanofi Licensing Pact
Cialis, which in 2013 edged out Viagra as the best-selling impotence drug worldwide, is the fourth best-selling drug for Eli Lilly & Company. The licensing deal that Lilly struck with French pharmaceutical manufacturer Sanofi ensures that Lilly will still continue to profit from Cialis after its patents have expired in the United States and elsewhere.
In announcing the licensing accord on May 28, 2014, Vincent Warnery, senior vice president of Sanofi’s Global Consumer Health Division, said, “This agreement provides us with an opportunity to work with Lilly, a leader in men’s health, to transform how this important medicine is offered to millions of men throughout the world.
“The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare’s leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi,” said Warnery.
Would Expand Access to Drug
For its part, Lilly is “pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription,” said David Ricks, president of Lilly Bio-Medicines.
“Switching a medicine to over-the-counter is a highly regulated process that is data driven and scientifically rigorous,” said Ricks. “Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately.”
Under the terms of the licensing arrangement, Sanofi would take on the responsibility of promoting Cialis OTC in markets where the OTC version is approved, but the drug would continue to be manufactured by Lilly.
Competition from Fakes
Even though Lilly’s patents for Cialis are alive and well, the drug already faces competition from counterfeit versions that are sold online and illegally promoted as “generic Cialis.” These fake drugs are produced without supervision and are often found to contain harmful substances, such as drywall compound used as a binder and paint or printer ink used as a coloring agent.
Before an OTC version of Cialis ever hits the shelves at your local pharmacy, it will have to win the approval of the Food and Drug Administration, the federal agency responsible for assuring the safety, effectiveness, quality, and security of human drugs, both prescription and OTC. Predicting how the FDA might rule on an application to sell Cialis over the counter is a guessing game since no clear-cut precedent exists.
Cialis OTC would have to clear similar hurdles with regulatory agencies responsible for other markets, such as the countries of the European Union. The European Medicines Agency is the regulatory authority responsible for overseeing the marketing of drugs in the EU.
Viagra OTC Bid Withdrawn
Back in 2008, Pfizer withdrew an application to market an OTC version of Viagra in the European Union after the EMA expressed concern that allowing men to get the drug without seeing a doctor increased the risk that other underlying health problems might be overlooked.
Although it withdrew its application, Pfizer made clear that it disagreed with the agency’s opinion. The pharmaceutical company noted that “millions of men in Europe are currently circumventing the healthcare system when seeking ED medicines, exposing themselves to unnecessary risks of medicines from uncontrolled sources and the missed opportunity to get important health information from a healthcare professional.”
Cialis, currently available only by prescription, was approved in 2002 by the EMA as a treatment for impotence and won approval for U.S. sales from the FDA in 2003. The drug is also prescribed for the treatment of benign prostatic hyperplasia, a noncancerous enlargement of the prostate gland.
PDE5 Inhibitors
Along with Viagra, Levitra, Staxyn, and Stendra, Cialis is a member of a family of drugs known as PDE5 inhibitors, so-called because they temporarily block the effects of an enzyme known as phosphodiesterase-5. The PDE5 enzyme can impede strong blood flow to the penis, which is essential to achieve and maintain an erection.
Along among the PDE5 inhibitors, Cialis is marketed in two different formulations, one that is designated as Cialis for Daily Use and another known as Cialis for Use as Needed. Daily-use Cialis comes in 5-milligram tablets and are designed to be taken once daily to ensure that erection is attainable when appropriate.
‘Weekend Pill’
Nicknamed the “weekend pill,” Cialis for Use as Needed comes in 10- and 20-milligram tablets that are to be taken at least 30 minutes before sexual activity. This form of the drug is effective for up to 36 hours, which is how it earned its nickname.
Among the many issues that regulatory authorities will consider in evaluating the application for Cialis OTC are the drug’s side effects and its adverse interaction with other medications.
Generally speaking, the side effects of Cialis are mild and tend to disappear after the pill has been in use for a short time. The most common side effects include headache, indigestion, runny or stuffy nose, back pain, muscle pain, temporary flushing of face and neck, and cough.
Serious Side Effects
Although rare, more serious side effects from Cialis have been observed. These include impaired hearing or vision, temporary loss of hearing or vision, chest pain, and an erection that lasts for four hours or more. Any patient who experiences these more serious side effects should see a medical professional as soon as possible.
Cialis and the other PDE5 inhibitors all temporarily lower blood pressure, which makes them incompatible with medications that have a similar effect. Most notable among these are nitrate-based drugs, such as nitroglycerin that is prescribed for the treatment of angina. Taken in combination, PDE5 inhibitors and nitrate-containing drugs cause a precipitous drop in blood pressure, which in extreme cases could lead to death.
Incompatible with ‘Poppers’
Also incompatible with PDE5 inhibitors, such as Cialis, are the recreational drugs known as “poppers,” which usually contain amyl, butyl, or isobutyl nitrite, all members of the nitrate family.
Only time will tell whether regulatory authorities in the United States and elsewhere will approve the marketing of an OTC version of Cialis. In the meantime, the drug is available only by prescription.
If you’re looking for a reliable online source of Cialis and the other PDE5 inhibitors, pay a visit to eDrugstore.com, which supplies only FDA-approved medications through U.S.-licensed pharmacies. If you have a prescription from your family doctor, you can fax or scan and email it along with your order to eDrugstore. Alternatively, eDrugstore can arrange an online consultation with one of its licensed physicians who can authorize a prescription if he deems it appropriate. There is no cost for this service.
Don Amerman is a freelance author who writes extensively about a wide array of nutrition and health-related topics.
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