Recently in pharmaceutical research Category

"Pink Pill" for Women Moves Closer to Approval

Thumbnail image for research_icon.jpgThe long-awaited "female Viagra" could be on its way soon thanks to an important decision last week by an FDA advisory committee. The committee voted 18-6 to recommend that the FDA approve the drug flibanserin for the treatment of sexual dysfunction in premenopausal women.

The approval is a major victory for the drug's maker, Sprout Pharmaceuticals. In 2010 the FDA committee unanimously vetoed its approval, and Sprout filed an appeal. 

Sprout is not the only pharmaceutical company benefiting from the decision; shares of Palatin Technologies, which is working on a drug similar to flibanserin, also skyrocketed. 

The search for the elusive "pink pill" has been a long one -- because women's sexual response is governed by different physiological and psychological mechanisms than men's, treatment for female sexual dysfunction is much more complex. Unlike Viagra, whose primary effects are focused on blood circulation in the genitalia, flibanserin affects the nervous system and causes changes in the balance of the neurotransmitters dopamine and norepinephrine. In fact, it was originally investigated as an antidepressant. 

Unlike past contenders for the "female Viagra" title, flibanserin seems like it could be the real deal, and the vote for its approval is being hailed as a milestone by advocates of women's sexual health equity, such as Even the Score. Supporters say that the FDA has had a double standard for sexual dysfunction treatments for men and women, and the vote for the drug's approval represents major progress. 

Research Report: Is 100 mg the Best Starting Dose for Viagra?

Thumbnail image for research_icon.jpgTitle: Sildenafil Citrate 100 mg Starting Dose in Men with Erectile Dysfunction in an International, Double-Blind, Placebo-Controlled Study: Effect on the Sexual Experience and Reducing Feelings of Anxiety About the Next Intercourse Attempts

Source: Journal of Sexual Medicine, 2009, 6:2826-2835

Purpose of Study: Usually, patients are recommended to begin treatment with Viagra at a 50 mg dose. Later, if that doesn't work well, they may be increased to a 100 mg dosage. This is a standard method for administering medicines, since with a higher dose comes an increased risk of side effects. 

Erectile dysfunction, though, isn't just a physical issue it is a psychological one as well. So patients might be disappointed if they try 50 mg and cannot achieve the type of erection they were hoping for. So, it might be psychologically beneficial to instead start at the higher dose of 100 mg to avoid this performance anxiety.

Result of Study: "After treatment with sildenafil 50 mg or 100 mg, men felt less anxiety, and 56.3% of men initiating treated with 100 mg sildenafil felt no anxiety about he next intercourse attempt compared with 38.8% of men initiating treatment at sildenafil 50 mg." In other words, the men who started out at 100 mg were much more confident, with less performance anxiety, than those who started out at 50 mg. 

However, "Although improvements in functional measures were observed in the 100-mg group during the double-blind phase, the improvements were not statistically significant compared with the 50-mg group" In other words, the 100 mg patients didn't show much of a physical difference than the 50 mg patients. But they did show a different psychological reaction. This means that men may be very sensitive to very slight differences in erectile performance. 

Points of Interest: According to this study, most patients begin taking Viagra at 50 mg but then increase to 100 mg. This is an interesting claim, but doesn't align with the feedback we've received from readers of this site, most of whom seem to do well at 50 mg.

Open Questions: This study didn't examine carefully the differences in side effects experienced by the 50 mg and 100 mg groups. This is an important consideration which we'd like to see studied along with the psychological benefits of a higher dose.

Female Viagra Roundup, Firsthand

Thumbnail image for research_icon.jpgThere's no "Viagra for women" - everybody knows that, right? So when we saw the headline "I Took Female Viagra for a Week", it piqued our curiosity. Was this a new Biosante drug trial? And taking it for a week - that must have been tiring.

While there's no pharmaceutical for women that's an analog of Viagra (and not for lack of trying on the drug makers' parts), there are a lot of products passing themselves off as female libido boosters. Most of them are along the same lines as herbal Viagra, supplements that generally enhance blood flow and maybe energy.

Anyway, a female tester over at Vice tried out a bunch of these lady supplements and ranked them, from the worst (a caffeine-laden, migraine inducing cherry flavored shot) to the best (an herbal supplement called Gold Max that apparently turned her into an aggressive sexual beast).

The female Viagra conundrum is that men's dysfunction is most often a mechanical failure, whereas women's sexual dysfunction more often has psychological factors. Perhaps hoping to induce physical arousal so intense that it overwhelms any emotional issues, pharmaceutical manufacturers nevertheless continue to pursue the elusive magic bullet. Wait - isn't that a vibrator? Now that might just work.

Brushing Your Teeth? Keep It Up!

Thumbnail image for research_icon.jpgMany people find tooth flossing a chore, but would you be more likely to brush and floss regularly if you knew it might lessen your chance of getting erectile dysfunction? I know - having fresh breath is always beneficial to your love life, but what could your oral hygiene habits possibly have to do with your sexual functioning?

Well, researchers haven't found a direct link, but studies have found a marked correlation between gum disease and ED. In one study, four out of five men with severe ED had periodontal disease (gum disease); among men with mild ED the rate was less than two in five.

Gum disease is also linked to a number of other health problems, such as diabetes and heart disease. Periodontitis can result in bacteria from the mouth finding their way into the blood stream, causing damage to blood vessels. One theory is that this vascular damage extends to the blood vessels in the penis.

Whatever the connection, there's no real downside to maintaining good oral hygiene and a healthy smile, and it may contribute to your overall health as well.

FDA Reversing on Revatio for Kids

Thumbnail image for news-icon.jpgThe FDA has come out with a statement recommending against the use of Revatio (sildenafil) to treat pulmonary arterial hypertension in children under 17. Higher doses at this age, they say, can increase risk of death.

Revatio has been used in many pediatric applications, and it's a bit of a surprise to learn that it never was in fact approved for use in kids, so it's being used off label. In fact, the Revatio label will soon have a warning about use by youth.

Given the benefits of Revatio, it's likely doctors will continue to use it for pediatric treatment without the FDA's blessing.

Heartwarming Update: Toddler Saved by Viagra

Thumbnail image for news-icon.jpgA tiny baby with multiple birth defects, including a hole in her heart, is now a robust, chubby-cheeked toddler thanks to Viagra.

Baby Cerys, born 19 months ago in Wales, came into the world with no spleen, digestive problems, and a serious cardiac defect that required open-heart surgery at just five months of age. Doctors put her on a daily regimen of sildenafil, which is now often used to treat pulmonary hypertension in infants, and in this case helps her blood circulation. She gets a spoonful of liquid Viagra three times a day, along with other medications to manage her conditions.

Cerys took her first steps a couple of months ago, recently spoke her first words, and is now stringing together sentences. Apparently, one of her favorite phrases is "I want to walk." Also, "Talk to your doctor to see if Viagra is right for you," and "If you have an erection that lasts more than 4 hours, seek medical attention."

Cerys' doctors are hoping to wean her off Viagra eventually, but for now she's one of its youngest beneficiaries.

Kiss of the Spider Woman?

Thumbnail image for research_icon.jpgDoes the thought of spiders give you goosebumps and make your hair stand on end? They might raise more than hair. It sounds kind of scary, but according to a study recently published in the Journal of Sexual Medicine, spider venom (from the Brazilian wandering spider, to be precise) may hold a cure for erectile dysfunction.

The study found that the spider toxin PnTx2-6 improved erectile function in aged rats by increasing the availability of nitric oxide. Researchers think this may be of benefit to older men whose ED does not respond to Viagra, since the toxin uses different chemical channels.

How did researchers come up with the idea of testing spider venom as an ED cure? Well, priapism is a side effect of this particular spider's bite.

People use Botox, the toxin that causes botulism, for cosmetic procedures, so this doesn't seem much different. If it had to be administered by spider bite, that might be another story.

That's Nuts: Walnuts & Pistachios for Sexual Health

Thumbnail image for research_icon.jpgLooking for natural ways to bolster your male prowess and fertility? Here's some advice: Go nuts! That's what health researchers are saying - certain tree nuts can ward off prostate cancer, improve sperm health, and even combat erectile dysfunction.

In a 12-week study, men were asked to eat a handful of walnuts (about 2 oz.) daily. At the end of the study, their sperm was found to be healthier than volunteers whose diet did not include walnuts. The semen of those men who consumed walnuts showed a greater concentration of sperm, greater percentage live sperm, better sperm motility, and fewer sperm that were misshapen or had chromosomal abnormalities.

Researchers believe the polyunsaturated fats in walnuts are the effective component. Walnuts are high in linoleic acid and omega-3 fatty acids.

A diet rich in walnuts may possibly shrink or slow the growth of prostate cancer, an effect also credited to the nuts' fatty acids and antioxidants.

If you need some help in the ED department, try some pistachios. A study found that a daily serving of the green nuts (3.5 oz.) for 3 weeks improved the erectile function for men with ED - as well as improving their lipid profile, reducing bad cholesterol levels and raising good cholesterol levels. Researchers say that pistachios are rich in arginine, an amino acid that maintains flexibility in blood vessels, and can boost nitric oxide levels.

So,next time you're packing your lunch, don't forget to grab your nuts.

Spray-On Staying Power

Thumbnail image for research_icon.jpgMichael Wyllie, one of the team who developed Viagra, has a new contribution to the field of sexual health. Wyllie has invented a spray to help men with premature ejaculation last longer.

I know, that doesn't really sound like anything new. You can go online or to any adult store and get some kind of "delay cream", but Wyllie's concoction, named Tempe, is a bit different. While it's made from two topical anesthetics, it doesn't cause the numbing sensation similar products do. It can also be applied up to two hours in advance of sex, so you don't have to explain to your date why you're spritzing your junk.

The spray is also likely to be much cheaper and accessible than other pharmaceutical alternatives, such as off-label anti-depressants, or Priligy (dapoxetine). I'd also imagine it has fewer side effects than pills.

In trials, the spray helped some men last eight times longer, but the average user can expect to last around three times his typical duration. Apparently it doesn't do much to help men who don't have PE issues. No word on if it has any synergistic effect with Viagra.

Wyllie says he thinks the drug could be "the next blockbuster", and the spray could be on the market in Europe by fall of next year.

Recreational Viagra Has Its Downside

Thumbnail image for research_icon.jpgTaking Viagra when you don't need it? You may be setting the, er, bar too high for yourself, leading to real sexual dysfunction later on.

A study recently published in the Journal of Sexual Medicine surveyed 1200 college-age men, and found that those who used Viagra recreationally (6 percent of the subjects) were more likely to experience subsequent difficulty in sexual performance.

Using unneeded ED drugs doesn't cause any physical damage, according to urologists, but it can create a psychological dependence. Viagra abuse can make young men more prone to "self-monitoring" of their erections during sex. That kind of self-consciousness and anxiety about adequacy can lead to real difficulties in performing when the drug is not available.

Paradoxically, the study also found that  men who used Viagra for kicks were actually less satisfied with their sex lives overall than non-users, and were less confident about their ability to achieve and maintain an erection.

The study's authors admit they don't know if the subjects began taking ED drugs in the first place because they had anxiety about sexual performance, but it's clear if that was the case, the drugs didn't help the users' original concerns, and may have undermined the confidence of healthy individuals.