Recently in pharmaceutical research Category

Viagra already has a number of documented pediatric uses, and now we can add another. A small study at the Children's Hospital of Philadelphia has shown that sildenafil helps children with underdeveloped hearts. Children and young adults with a congenital heart defect called single ventricle heart disease palliation showed improved circulatory capacity and cardiac function after 6 weeks of treatment with the drug.

The condition can cause long-term illness and increased risk of death, even after surgical intervention. All the subjects in the study had previously undergone a procedure called a Fontan surgery to divert blood flow to the lungs. However, those blood vessels can become resistant, lessening the benefit of surgical treatment.

Echocardiograms showed that the drug had dramatically improved the heart's blood pumping capacity in those treated. The study was published in the journal Pediatric Cardiology.

Apparently it does. It's also stocked on supermarket shelves, in the juice and produce aisles.

I'm not talking about pharmaceutical Viagra, of course - I'm referring to the food that's being touted as the latest "natural Viagra".  Pomegranates, or pomegranate juice to be specific. Research has declared that drinking a daily glass of the ruby red elixir for two weeks produces "Viagra-like effects" for both men and women.

Didn't we go through this with watermelon a few years ago?

Anyway, pomegranates, which have had a reputation as an aphrodisiac since ancient times, are the farmers market Viagra du jour. A UK study found that regularly drinking pomegranate juice produced a surge of libido-lifting testosterone in both sexes, plus positive effects on mood, memory, and blood pressure.

As far as the Viagra comparison goes, watermelon is a more accurate analog, as it contains amino acids that relax blood vessels in a manner similar to sildenafil. Neither watermelon nor Viagra have any effect on testosterone production.

Libido-enhancement aside, pomegranate juice has a lot of other fine qualities, being chock full of cancer and heart-disease fighting antioxidants. I'm not usually one to go in for superfood fads, but I might consider adding this one to my daily regimen. Although I wouldn't be surprised to find the store out of stock after the announcement of this news.

There may soon be a new upstart entering the ED market - in a few days, the FDA will be reviewing Avanafil, the quick-acting PDE5 inhibitor.

The drug has already been approved in Korea, and has gone through Phase III testing in the US. Chances are, it will get approved in the US.

So, will another ED drug have an impact on the market? Probably not much, given that they all do pretty much the same thing. Avanafil's benefit is that it gets things going a bit faster than Viagra or other drugs and therefore might appeal to different users:

"Men who have a pattern of sexual activity that's predictable -- every Saturday night, or something like that, don't need this." Dr. Ira Sharlip a urologist at UC San Francisco and expert in the field of sexual medicine, sees the drug appealing to those who have more casual or sporadic encounters "If you see that things are heading in that direction, you pop a pill and are ready in 15 minutes, if  correct."

On the other hand, Avanafil clears the system quicker, so while it may cut down the wait time for the fun to start , it may be over sooner too.

One thing Avanafil has in its favor is that the side effects seem to be milder, especially the more serious cardiac symptoms. The headaches and stuffy nose just seem to come with the territory, but most users tolerate them.

Sharlip had an interesting take on some of Viagra's other supposed side-effects. "Despite what the FDA says, I have never seen priapism from any PDE5 inhibitor drug. Priapism is just not a clinical problem. Blue vision with Viagra is uncommon and at worst annoying. Most men who get the blue vision with Viagra don't care about it," he said.

Huh. I'd think that would be a little disturbing, but who knows - maybe some people like looking at the world through Viagra tinted"glasses.

Having trouble getting it up? Maybe you just need a hug.

The latest news from the erectile dysfunction front is a recently published case study is that  the "cuddle hormone" oxytocin, which is  linked to emotional bonding between sexual partners and mothers and infants, has been found to have dramatic effects on male libido and erectile capability, at least in some individuals.

Same as Viagra, the discovery of oxytocin's effect on male performance was accidental. The subject described in the case study was given the hormone in a nasal spray to help with social phobia and social difficulties related to Aspberger's syndrome. It helped some with that, but the unexpected payoff was in the bedroom.

His libido improved, going from "very weak" to strong, and his erections and orgasms were better - 46% better, going by a assessment scale someone dreamed up to quantify these things.

However, the  treatment was not without its side effects. The man "also hugged a work colleague in a 'very out of character' way." 

Since this is only one case, there are still a lot of unanswered questions. Will the hormone work similarly for men without Asperger's? Other research on oxytocin indicates it might, as over 25% of men in an unrelated study experienced improved erections when given oxytocin. Viagra also stimulates oxytocin production, which may account for part of its effect.

Only time will tell how this will pan out, but one of the scientists involved with the discovery and development of Viagra predicts that an oxytocin-based treatment could have 'blockbuster potential'.

Every few years it seems, a new treatment comes along that promises to make Viagra (and other erectile dysfunction drugs) obsolete. A while back it was electrical currents. Now it's sound waves.

The treatment involves firing blasts of low powered sound waves at the patient's private parts, It's supposedly painless - just some tapping followed by a tingling sensation. The sound waves, which in other applications have been used to break up kidney stones and reduce joint inflammation, somehow stimulate the genital tissue to generate more blood vessels. That means more blood flow, and better erections.

The treatment is currently available in the UK, at a cost of about $2500 for a dozen 15-minute treatments. The machine the doctors use to administer the sound waves is a big cart-like contraption called the ED1000. Sounds like some kind of sexbot or a high tech vibrator. Well, actually, it is a high tech vibrator.

Researchers note that the treatment is only effective for those whose ED has a physical cause, such as diabetes or heart disease; it doesn't help those whose impotence is related to psychological issues. Those folks might benefit from other low-pitched sound waves - like maybe a Barry White album.

Viagra has a history of unforeseen beneficial side effects and happy accidents - it started off as a heart medication, after all.  Now doctors have discovered another medical application for the drug, in what Dr. Richard Smith, a pediatric otolaryngologist calls an "exciting and serendipitous finding."

According to a small study and preliminary report, sildenafil can shrink disfiguring lymphatic growths in children, know as severe lymphatic malformations. The cause of the growths is unknown, but the masses of fluid and lymphatic vessels can grown as large as a basketball.

Doctors aren't sure how sildenafil works to shrink the growths, but one theory is that it stimulates circulation in the lymphatic system, allowing fluid to drain. The drugs new-found property was discovered while an infant was being given sildenafil for pulmonary hypertension, and doctors observed that a lymphatic growth shrunk during the treatment.

The cost of the treatment is reportedly up to $1,000 a month, but Pfizer has been donating the drugs. That's great - they win some points for that. But my question is, why is it so expensive in the first place? The drug is Revatio, which is essentially the same thing as Viagra, right? Is it just more expensive because it's packaged in a different dosage? That's one of the silly things about the pharma business - they charge you more for a smaller dose.

Anyway, the discovery is good news for kids with this rare condition, and may not be a cure, but at least offers hope for treatment.

Nitric oxide, the catalyst for Viagra's magic, has a number of other important functions in the body. It's been established that NO can stimulate healing (besides sexual healing, wise guy). NO has properties that combat bacteria, stimulate immune response, and promote healing in wounds, and it's ideal for tough-to-treat MRSA (methicillin-resistant S. aureus) infections. The problem is that it's a gas, and so far there hasn't been a good way to deliver it to the site of an infection.

Welcome to the world of nanoparticles. Nanoparticles are - well, the most important thing about them is that they're really, really, really tiny, so they can go places bigger particles can't. Now researchers have developed NO-releasing nanoparticles that can penetrate skin, where they unleash that NO like scrubbing bubbles on infected soft tissue.

Oh, yeah - and the nanoparticles had one other interesting effect in lab tests: they caused rats to get erections. Bonus.

So, how do you think the researchers came up with that bright idea? One of the co-authors of the paper describing the study "notes that, beyond the antimicrobial and wound healing applications, the important role of nitric oxide in maintaining vascular health also lead to the team's testing of the efficacy of NO nanoparticles in addressing conditions associated with endothelial dysfunctions."

Translation: "We know what Viagra does, so we thought we'd give it a shot and see if this worked too."

"NO nanoparticles were shown to increase erectile function when applied topically to the penis of rats...and even more importantly, in a post-radical prostatectomy animal model with cavernous nerve transection - a clinical scenario in which PDE-5 inhibitors (Viagra) are ineffective."

Sorry. Now you all need a little brain bleach to expunge the image of some unfortunate lab assistant tasked with applying this stuff to rat genitalia, but the takeaway is that it may be able to get the job done even when Viagra can't - giving hope to those whose erectile dysfunction is Viagra-resistant.

I could see the development of NO-delivering nanoparticles having a similar trajectory to that of Viagra: a drug developed for one purpose that turns out to be wildly effective at something much more compelling. Oh, sure, saving lives is great and all, but face it, stiff erections trump staph infections.

If you know your Viagra history, you know that the drug sildenafil was originally developed as a medication to treat heart conditions and high blood pressure. At the time, it was considered a flop at that, but more than made up for it with its spectacular sexual side effects.

Viagra's monumental property of countering erectile dysfunction all but eclipsed any other medical applications. There has been some continued research, and sildenafil has proven effective in treating pulmonary hypertension as well as a few other less common conditions.

Now it seems researchers were perhaps a little too hasty in tossing in the towel on using Viagra for cardiac treatments. Some 15 years later, a recently published study shows that sildenafil may have dramatic benefits for patients suffering from diastolic heart failure, working within minutes. This has big implications. "Of all the patients aged over 60 who are in hospital because of a weak heart, half suffer from diastolic heart failure" explains Prof. Dr. Wolfgang Linke, author of the study.

The article indicates the initial experiments were done with dogs having diastolic heart failure. Perhaps that's what was ailing Ingrid the pitbull, who we met in our last post. She was rescued from death's door step by a quick-thinking vet who prescribed Viagra. Maybe the doc was ahead of the curve and had already read the medical literature.

Paradoxically, the drug helps by relaxing heart tissue that has become too stiff. Not what comes to mind when you think Viagra, but the enzyme that the drug inhibits acts differently in different organs of the body.

Just goes to show, the little blue pill truly is a wonder drug: it softens hard hearts and hardens soft...

Condom maker Durex announced last week the launch of a new condom produced in partnership with Futura Pharmaceuticals that could revolutionize the way men look at prophylactics. In fact, it may even give some incentive to slip into one. And  its producer are hoping it may help them gain some ground against Trojan, which rules the U.S. condom market with a 75% share, compared to Durex's 6-8%.

Dubbed "Viagra in a condom", the product is intended to help men who have difficulty staying erect or may feel inhibited by wearing a rubber. The condom tip contains a small amount of Zanifil gel, which will stimulate blood flow to the wearer's penis, resulting in a firmer, larger erection. An additive aids in quick absorption through the skin. The gel is derived from nitroglycerine, which dilates blood vessels (like Viagra, it raises levels of nitric oxide, but by a different mechanism). It acts pretty fast, so your little soldier won't be left dangling there like a deflated balloon animal.

So, is this a Viagra killer? Nah. There isn't any comparison yet of effectiveness, but I'd be willing to bet that a dab of Zanafril doesn't pack the same punch goof ol' Vitamin V. Plus there will be some people who won't be able to use this product. There's not been much mention of side effects, but it's guaranteed that the gel will give someone a rash (in a very uncomfortable spot), and if the condoms are latex, that precludes anyone with latex allergies. However, the product is likely to be popular with younger men who have occasional difficulty, confidence issues, or feel that Viagra is for geriatrics.

The condoms over-the-counter availability has been a selling point, but we could also see where that could be a drawback. When you slide these over to the checker at the drugstore, you're basically broadcasting to the world: I can't stay hard. So we predict there will be big bucks to be had selling these online. No word on a price tag, although the maker has said they will have a "premium" cost. Hmm. What could that mean? Something like $5.00 each?

The makers foresee another possible setback. Women buy about 40% of the condoms sold. Says Futura CEO James Barder: "If the packaging says it will give you a bigger penis, and a woman gives it to a man, it might cause a reaction, like 'What, you're saying my penis is small?'"

Or, "What, you're saying I can't stay hard long enough to satisfy you?"

Apparently without irony, Barder added:
"This area does have sensitivities. Positioning is critical."

Indeed.

Hope springs eternal that a remedy will be found for low female libido, but that search has suffered another setback. BioSante Pharmaceutical's stock plunged on the news that its "female Viagra" drug, LibiGel, was no more effective than a placebo in trials. The topical formula is a testosterone gel for women.

Other studies suggested that their formula worked (and testosterone cream is often prescribed "off label" to treat low sex drive in women), so the company expected safety concerns to be its biggest obstacle.

Although Pfizer gave up several years ago on using sildenafil for women, there were reports last year that the company was looking into another drug - a compound called UK-414,495 - but then that seemed to hit a dead end as well.

Why is the formula for "female Viagra" so elusive? Maybe it's because comparing female and male sexual response is like comparing apples and oranges - or apples and bananas, if you prefer. Viagra works on the hydraulics of the sexual anatomy - the  blood vessels that engorge the genital tissue - not the mechanisms that generate libido or sexual desire. The assumption is that's a given, that guys will have no problem with "wanting" to have sex. The issue is not desire, but ability to perform. Whereas with women, it's often the interest itself that needs to be stimulated.

Maybe that's why the placebo was just as effective as the drug in the trials - they say the most important sexual organ is between your ears.