Tag Archives: viagra

Generic, cheaper Viagra is coming soon to an over-the-counter near you

As drug giant Pfizer loses its patent monopoly over the most famous erectile dysfunction drug, Viagra is set to become a generic product costing only a fraction of its former price.

The blue pill is turning white

The little blue pill paved the way for a more open discussion about a problem that most men come across at least at some point in their life: erectile dysfunction. Although it’s something that can have a dramatic effect on the quality of life, most men prefer not to address it at all. Viagra came in and, at least partly, changed that. It brought with it a long series of bad jokes and became widely popular on the black market, but most importantly, it solved many problems. Launched two decades ago, Viagra offered an easy solution for the private frustration of millions of men, though it did not come cheaply.

The retail price of Viagra is $65, so it’s not exactly the cheapest drug. However, Eli Lilly’s Cialis came out in 2003, becoming the market leader and leaving Viagra as a close second. It remains to be seen if that changes; as of next year, Viagra will only cost half its price today and be widely available.

“We believe that the story for Viagra isn’t done. It’s just going to be a new chapter,” said Jim Sage, president of U.S. brands for Pfizer Essential Health, which sells its older medicines.

While the price and the overall aspect of the pill might change, the active substance (sildenafinil) remains the same. Sildenafinil inhibits an enzyme called phosphodiesterase 5 (PDE5). PDE5 restricts the flow of blood to the penis — when it is inactivated, more blood flows to the penis, causing an erection. Sildenafinil was devised as a drug for treating high blood pressure and chest pain, and in some instances, it still is used (i.e. it can treat pulmonary arterial hypertension which affects premature babies). But without a doubt, its most popular usage is tightly related to male sexual performance.

In the US alone, 12 million prescriptions for Viagra and Cialis were filled last year. Pfizer says that according to its market studies, 20% of users are very loyal to Viagra, and as a result, they will be making their own generic version instead of giving up sales to generic producers, as big pharma often does. Furthermore, starting January, the drugmaker will offer two new discount programs, ensuring that the drug can be accessible to uninsured men.

“This is the most comprehensive pricing and marketing response I’ve seen to a generic,” said Erik Gordon, a pharmaceuticals analyst at the University of Michigan’s business school. “It’s unprecedented.”

Making the pills more accessible will certainly benefit many people, but it remains to be seen whether they will remain loyal to the mother company or switch to other generic brands.

Viagra will be available over the counter in the UK

The famous male potency drug just became more accessible in Britain.

Image credits: Tim Reckmann.

Pfizer’s Viagra was the first prescription erectile dysfunction drug to market, in the late 1990s. Now, the UK Medicines and Healthcare products Regulatory Agency (the rough equivalent of a British FDA) has decided that the drug will now be sold over the counter. The main idea behind this decision is that people won’t need to visit their general practitioner to talk about their impotence — a talk that’s often so embarrassing and unpleasant that many men skip it altogether, even if it means further displeasure down the line. Another aspect which tipped the balance is that many men were already buying Viagra from illegally-operating websites. Mick Foy, MHRA’s group manager in vigilance and risk management of medicines, said:

“This decision is good news for men’s health. Erectile dysfunction can be a debilitating condition, so it’s important men feel they have fast access to quality and legitimate care, and do not feel they need to turn to counterfeit online supplies which could have potentially serious side-effects.”

Now, it will be up to pharmacists to decide whether it is appropriate to sell Viagra or not. The drug will not be available to:

  • those with severe heart disease or at high risk of cardiovascular disease;
  • those with liver failure;
  • those with severe kidney failure;
  • men taking certain medicines that could cause a bad reaction when combined with Viagra.

They don’t often talk about it, but most men have experienced an erectile problem at least once in their life. Leading causes are stress, tiredness, anxiety, or drinking too much alcohol. However, this isn’t really a health problem unless it starts to happen regularly, at which point men can choose to talk to a doctor or self-medicate. Men who take Viagra are advised to take a 50 mg tablet an hour before having sex and never take more than one a day.

Viagra achieved peak sales of more than $2 billion in 2012 but since then, sales have declined as patents have started to expire, Pfizer to explore extending its brand value as a non-prescription drug. At this point, Viagra is the most popular erectile dysfunction medicine and the only one to be reclassified from “prescription only medicine” to “pharmacy” status in Britain.

flibanserin

‘Pink Viagra’ pill for low libido women seeks FDA approval, but is it safe?

A drug called  Flibanserin, also known under the name of Addyi, is marketed as the first designed to boost a woman’s sexual desire. This week the FDA will decide whether to approve the drug or not, however looming safety concerns could count against Sprout Pharmaceuticals, the parent company marketing the Flibanserin.

flibanserin

Maria Fabrizio for NPR

“Not tonight, honey”

Flibanserin intends to be the first-ever drug to treat hypoactive sexual desire disorder (HSDD), a form of chronic low sexual desire, in women. HSDD is affecting 16 million women in the US. The disorder itself, however, doesn’t look much like a disorder, though it appears to have become an official diagnosis in the  International Classification of Diseases used by clinicians and gynecologists. It’s a dubious disorder, to say the least, since there’s no clear biological cause of the disorder or any diagnostic test other than a questionnaire. Basically, if you’re a women who feels no urge to have sex with your partner or anyone for that matter, than you fall in this spectrum. Women with HSDD can still enjoy sex and have orgasms like other perfectly healthy woman. It’s just that they don’t feel like it.

The FDA previously rejected the female libido pill twice since 2010. The decision in 2005 was unanimously against it, mostly because of the side effects which include dizziness, nausea and sleepiness. Taking the drug at the wrong time of day or with alcohol may also cause rare instances of fainting from low blood pressure. Also, women need to take the pill once a day for months before they can see any improvements in their sex drive.

Moreover, critics have voiced concerns that Flibanserin bears little improvements over placebo control groups, which is why it was rejected by the FDA in 2009 and 2013. Afterwards an  advocacy group called Even the Score, sponsored by Sprout, accused the FDA of sexism. Why allow Viagra and other erectile dysfunction drugs, which granted also bear nasty side effects, but not Flibanserin? Apparently, cornered, the FDA  advisory panel approved the drug on the condition that its manufacturer develops a plan to limit safety risks. The vote was preceded by testimony from women who urged the agency to approve the drug and told about their fears of never being able to have sex again.

“I should be able to determine if Flibanserin is worth the benefit of treatment,” said Amanda Parrish, one of more than 11,000 women who participated in a clinical trial of the pill.

“What a relationship-saving eight months that was,” she said.

The issues the FDA has with Flibanserin have less to do with gender bias, and more to do with the drug itself, though. Enthusiasts were quick to point out after the last rejection that there are 20 FDA-approved drugs to treat male sexual dysfunction and a whopping 0 for women, but reality is different. There is no drug currently approved for treating low sexual desire in men or women. What Viagra and other drugs like it do is deal with the mechanics of erectile dysfunction rather than brain chemistry.

Women taking the drug reported experiencing only between one-half and one more satisfying sexual events per month than volunteers taking a placebo.

“The fundamental question is whether these observed placebo-corrected treatment effects outweigh the risks associated with treatment,” the FDA said in its latest review.

How does Flibanserin work?

Flibanserin is a 100 mg tablet taken daily at bedtime that is under review forhelping women with low sexual desire to have more satisfying sexual experiences and less emotional distress. Photo credit: Sprout Pharmaceuticals

Flibanserin is a 100 mg tablet taken daily at bedtime that is under review for helping women with low sexual desire to have more satisfying sexual experiences and less emotional distress. Photo credit: Sprout Pharmaceuticals

Though there isn’t any biological marker that could help diagnose HSDD, brain scans reveal that HSDD women have lower response to erotic material than those of other women. Doctors believe this can be attributed to  imbalances of serotonin and dopamine which can cause a sudden lapse in sex drive.

Flibanserin was initially developed as an antidepressant by a German company called Boehringer Ingelheim.  “It’s a neurotransmitter reuptake inhibitor, like many other approved antidepressants,” says John Thorp who was the principal investigator for flibanserin studies in North America under Boehringer Ingelheim. The drug has since been bought by Sprout. In effect, the drug  increases dopamine and norepinephire and decreases serotonin in the brain, thought to lower feelings of inhibition. Just like Viagra didn’t work as initially intended (to lower blood pressure), so did Flibanserin fail as an antidepressant. On the upside, it seemed to increase libido.

But is “not filling in the mood” worth the side effects? Having sex once or twice a month can mean all the difference for some women. Some critics, however, feel that HSDD isn’t a real disease, but a natural “phenomena of aging, and this drug is trying to jazz up women’s sexuality to meet the hypersexual world in which we live,” Thorp says. “After all, aerobic fitness at 40 isn’t what it was at 20.” Despite there are many women in their twenties classed as HSDD or “not tonight”, most are over forty.

Since it was last rejected by the FDA,  a panel of real women living with HSDD has been assembled so that the agency may better understand their wishes and concerns. If there’s a real disease for which there is currently no treatment, the FDA is obliged to take all steps necessary to alleviate this need. The FDA also requested more safety and side effect information about the drug.

I can understand why some women would want Flibanserin, but I’m not sure about treating sexual desire as a problem, lack of it I mean. This all seems like an over simplification. If you don’t have sex, then you’re in trouble. “What’s wrong with you?” Well people, both men and women, some of them, just stop having sex past a certain age. Maybe that’s normal. Maybe Flibanserin – the whole concept – is abnormal.

“The misrepresentation that everybody should be having it — needs to have it, wants to have it, has a problem if they don’t have it — is to change, really, what sexuality is into more of a medical thing,” says Leonore Tiefer, a psychologist at New York University. “I think that’s a terrible direction for knowledge, for understanding, for society.”

viagra

Viagra has its nasty side effects, but skin cancer isn’t one of them

Last year, a report highlighted a potential link between use of erectile dysfunction drugs, like Viagra, and melanoma. The news caused quite a stir, but in reality the findings are likely just a correlation mishap. Writing in  the Journal of the American Medical Association researchers at NYU Langone Medical Center found no such evidence when they systematically combed through the records of 20,235 mostly white Swedish men. Instead, the observed incidence, which is quite striking, is likely due to socio-economic factors (men who take viagra are generally better off, and can afford vacations in sunny locations where they risk getting skin cancer) than a cause-effect relationship between Viagra and skin cancer.

viagra

Image: mindbodygreen.com

In 2014, 142 cases of men who had taken Viagra and been diagnosed with melanoma were reported. Stacy Loeb, an urologist at New York University, wasn’t convinced though. She assembled a team and began doing their own research. The team tapped a Swedish healthcare database, given that the records are extremely well put together featuring instances of disease, treatments, but also lifestyle choices. Among the  20,235 records of Swedish men, the researchers found  435 of them had filled at once for a Viagra subscription or substitute (Levitra, Cialis).

Initially, Loeb alarmingly noticed that those men who had tried the erectile dysfunction drugs bore a 21% higher risk of malignant melanoma. This seemed to confirmed the hyped findings performed earlier by the other group. Loeb’s decided to look at other metrics, in case they missed some important association or lack thereof. Indeed, they found that those men who had ingested more Viagra didn’t show an increased risk of developing skin cancer. In medicine, there is this “dose relationship” effect which says the more of disease-causing drug is ingest the greater the risk of developing that affliction. This wasn’t the case. Next, the researchers also looked at the “dose response.” Basically, the higher the half-life of a drug (the time it takes to get flushed out of the body), the greater the risk of developing an associated disease. Of the three erectile dysfunction drugs, Cialis has the long half-lime. Once again, there was no particular difference in risk of developing melanoma between the individuals taking the other two drugs.

[ALSO READ] Why Viagra makes you see everything blue-tinted

 

This likely settles it: viagra doesn’t cause skin cancer. Still, those people stuck with melanoma aren’t a fabricated statistic – their condition is real. So what’s causing it? Loeb notes that those men who get melanoma tend to have higher disposable incomes and education levels. In other words, they can afford more lavish vacations in exotic locations where there’s plenty of sun. To be sure this wasn’t just a hunch, the team also screened for another skin cancer called basal cell carcinoma. They found the same risk as in melanoma (19 to 21%), but basal cell carcinoma works with different biological pathways than those involved in PDE5i use and malignant melanoma. PDE5i is short for phosphodiesterase type-5 inhibitors, the active substance in the erectile dysfunction drugs. If theoretically melanoma could have been biologically triggered by Viagra, there’s no way the drug could have produced basal cell carcinoma.

“What our study results show is that groups of men who are more likely to get malignant melanoma include those with higher disposable incomes and education—men who likely can also afford more vacations in the sun—and who also have the means to buy erectile dysfunction medications, which are very expensive,” says lead study investigator and NYU Langone urologist Stacy Loeb, MD, MSc.
“While medications for erectile dysfunction come with serious risk of a drop in blood pressure if taken together with other medicines called nitrates, overall they are safe medications, and our results suggest that physicians should not be concerned that the drugs cause melanoma,” says Loeb, an assistant professor at NYU Langone and member of its Perlmutter Cancer Center.
So, the takeaway would be to always wear sunscreen if you plan on staying out in the sun! As for Viagra, it has its fair share of nasty side effects, loss of hearing and vision of note. You should worry more about those than cancer when taking erectile dysfunction drugs.

 

Viagra to be used for children with lung condition

Viagra isn’t just for grown ups, not anymore. As a matter of fact, few people know that at first, viagra was used to treat pulmonary arterial hypertension (PAH), and treating erectile dysfunction was just a bonus; of course, the huge advantages that the ‘bonus’ provided made it into the most effective and sold medicine out there, for men with problems downstairs. However, Viagra seems to be turning to its roots, at least in this case.

The European commission has approved treating children Revatio (as Viagra is also sometimes called) for a rare, deadly lung condition. It was already used to treat adults with high blood pressure in the lungs, and now it can also be given to children aged 1 to 17. Pfizer (the drug company which sells it) is trying to get it approved in European countries.

The approval for these cases comes as a result of a study that was conducted, and which concluded that Viagra helped reduce arterial lung pressure in children, and was effective in treating PAH, helping the children breathe better and helping the lungs function better.