Viagra and Viagra connect are the same drugs, containing the same thing called sildenafil. The company, Pfizer, produces both of them in the same factories (1). But then the question arises why two different names of the same thing?
Well, the reason lies in the law rather than in medicine. Viagra is a prescription-only drug, meaning that one can only get from a pharmacy through a proper medical prescription. Viagra connect is a new approach to the same medication, and it can be procured, just like any OTC medication, like an aspirin. It also means less control over its sales, and Viagra connect may become available even in supermarkets (2).
There are several reasons for this phenomenon. This article looks into details, how this process happens, and why certain medications remain prescription only, and others become OTC. There is a whole science behind them, supported by the legal structure.
Difference Between OTC and Prescription Drugs
Almost every drug starts its long journey from labs and then gets approved as a prescription drug. It is very challenging to get a waiver by the government or the federal agencies to market any pharmaceutical product as an OTC.
Once any molecule is out of the lab, it at least goes through four stages of development. Phase one trial in a small number of people to prove the safety and validity of the concept, and phase two is to confirm that it is safe and still works (3).
Phase three is pivotal, as it focuses heavily on the working of drug and pharma companies carries out a clinical trial in a large number of humans. There is a reason why they call it pivotal, since, if this phase is successful in demonstrating the working/efficacy of the drug, it gets a nod for sale as a prescription drug from regulatory agencies. Phase one to phase three generally last for several years, costing billions of dollars to companies.
Phase four is called the post-marketing phase. During this period manufacturer of the drug continues to collect data regarding the safety of the drug in the population. Sometimes, a drug that looks safe may show rare and unexpected side effects when used by a larger group of people.
Needless, to say that Viagra has successfully passed the phase four checking multiple times. More than a billion men used billions of sildenafil doses in the last few decades to prove that this medication is highly safe.
Why Viagra Connect/Sildenafil Got Status of OTC
There is no secret that men want easy access to Viagra. They want to buy it like paracetamol, aspirin. After all, erectile dysfunction is an irritating and embarrassing issue. People want to control the situation, and thus they are demanding that governments ease the regulations.
Additionally, everyone is now confident about Viagra or sildenafil, as most people, including federal regulatory agencies, know that it is mostly safe. In a legal language, such a drug is called grossly safe or generally recognized as safe (GRAS) (4).
After a quarter of a century, and due to the high demand of sildenafil, government agencies decided to allow free sales of Viagra as OTC. This legalizes its sales through supermarkets and websites.
However, this also poses some challenges to the pharmaceutical company. Since Viagra is written as a prescription drug everywhere, thus instead of trying to erase all that information, it is far simpler to introduce it under similar yet new name – and thus, Viagra-connect came into light.
What Does This Mean for Users?
So, in short, this article is saying that there is zero/nil difference in Viagra or Viagra connect from the consumer's point of view. They differ only in the legal term. Thus, one can use either Viagra or Viagra connect.
For end-users, it means that finally, sildenafil will become legally available widely. This also means that websites get the legal right for sales of Viagra connect. For end-user, it means reduced cost, more confidence in quality, and lesser chances of falsification.
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It also means that finally, men can legally take charge of their problem of erectile dysfunction, without the need of a doctor.
It also says a lot about the safety of the medication. Since it means that regulatory agencies now think that it is almost as safe as paracetamol or aspirin or regular use, and thus there is little need for strict regulation.
Overall, Viagra-connect is big and good news for millions of men living with erectile dysfunction. Finally, no more embarrassing and repeated visits to the doctors. It is the freedom to buy it online or anywhere with confidence.
There is only a small downside to all this. It may now go out of insurance coverage for a small number of individuals. Since it is not a prescription drug, many regulatory agencies would think that there is no need for insurance agencies to pay for it.
Concluding Remarks
Viagra and Viagra connect are both the same things; one is with a prescription and another available without a prescription.
The decision to make Viagra OTC has broader implications, meaning better availability for consumers, more generic players, and reduced price, and yet better quality.
Non-prescription does indicate that government agencies now identify sildenafil (both Viagra and Viagra connect) as grossly safe. However, there is still a need to follow up with a doctor, at least twice a year. Additionally, now more responsibility lies on consumers to understand the possible side effects of the drug.