A pink pill designed to boost sex drive in women — the latest attempt by the drug industry to find a female equivalent to Viagra — fell short in two studies, federal health regulators said Wednesday.

The Food and Drug Administration is considering Boehringer Ingelheim’s drug flibanserin for premenopausal women who report a lack of sexual desire, a market that drugmakers have been targeting for more than a decade since the blockbuster success of Viagra in men.

The search for so-called “female Viagra,” has proved elusive though, with many drugs abandoned after showing lackluster results.

On Friday the FDA will ask a panel of experts to weigh in on the safety and effectiveness of Boehringer’s drug. The agency is not required to follow the group’s advice, though it often does.

In its review posted online, the FDA said two Boehringer studies failed to show a significant increase in sexual desire, as recorded by women in a daily journal. Women taking the drug reported slightly more sexually satisfying experiences, but FDA said that was not the primary measure of the study.

“The division wanted to see that an effect of treatment is an overall increase in sexual desire regardless of whether a sexual event occurred or not,” states the FDA review.

The FDA also noted increased side effects like depression, fainting and dizziness seen among women taking the pink pill.

The drug, which is related to the antidepressant family, affects serotonin and several other brain chemicals, though it’s not clear how that increases sex drive.

“We don’t know specifically what the exact mechanism of action is but we believe it acts on brain chemicals that have a role in human sexual response,” said Dr. Peter Piliero, executive director for Boehringer’s U.S. medical affairs.

Since the launch of Viagra in 1998, more than two dozen experimental therapies have been studied for so-called “female sexual dysfunction,” a market which some analysts estimate at $2 billion.

Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital in New York, says arousal in women is so complicated that it may be unrealistic to expect a pill to completely address sexual problems.

“It’s a fairly complicated area, unlike in men’s sexual dysfunction where there’s a major mechanical concern,” said Kavaler. “In women there’s no mechanical concern, so if she’s not having a successful sex life, where is the problem?”

Pharmaceutical approaches to boosting female libido have evolved over time. Initially, most treatments aimed to increase blood flow to the genitals, similar to Viagra. A second wave of would-be blockbusters focused on boosting hormones, including testosterone, which is linked to sexual interest. Flibanserin is the first drug to approach the problem through brain chemistry.

The FDA has approved an unusual handheld vacuum device that increases blood flow to the clitoris to increase sexual arousal. But all drug therapies have fallen short so far.

In 2004, Pfizer halted its study of Viagra in women due to inconclusive results. Later that year an FDA panel rejected Procter & Gamble’s testosterone patch Intrinsa, due to potential risks of heart disease and cancer. Smaller companies are currently developing creams and nasal sprays to increase female libido.

BioSante Pharmaceuticals Inc. expects to submit its testosterone gel LibiGel for FDA approval next year.

Medical surveys have estimated more than 40 percent of women suffer from some form of sexual dysfunction; Boehringer estimates as many as one in 10 women could be helped by its drug.

Boehringer tried to zero in on the chemical aspect of sexual dysfunction by only testing its drug on premenopausal women who were in stable relationships and not taking other medications. Despite wanting to have a sexual relationship, the women enrolled in company studies reported a persistent lack of desire that caused them “distress or interpersonal difficulty.”

Leonore Tiefer, a psychiatry professor at New York University who runs a private sex therapy practice, believes drugmakers have oversimplified female sexuality. She says in most cases lack of sex drive has more to do with the quality of one’s relationship and lifestyle than brain chemicals.

During the public comment period at Friday’s meeting, Tiefer will ask the FDA to reject flibanserin, arguing it offers meager benefits for women with unknown long-term risks.

The modest results reported by Boehringer have also cooled Wall Street’s expectations for the drug.

Decision Resources analyst Alasdair Milton said he expects flibanserin sales to peak at $300 million after six or more years on the market. By comparison, male sexual dysfunction drugs including Viagra, Cialis and others posted combined sales of $4.4 billion last year, according to health care data firm IMS Health.

Privately-held Boehringer Ingelheim posted sales of $12 billion last year. The Ingelheim, Germany -based company makes a range of prescription drugs for heart disease, HIV and other diseases.

Technorati Tags: BioSante Pharmaceuticals, Boehringer, female sexual dysfunction, female viagra, pink pill, prescription drugs, Viagra

People who buy prescription medications over the Internet, especially drugs purporting to treat erectile dysfunction, are playing Russian roulette with their lives, a new study contends.

At best the drugs won’t help you and at worst they could kill you, the review article said.

“You may be wasting your money or you may actually be hurting yourself,” said Dr. Margaret E. Wierman, professor of medicine at the University of Colorado at Denver and chief of endocrinology at the Denver VA Medical Center, who was not involved with the study.

Counterfeit Internet drugs are a mushrooming problem. Seizures of fake drugs in Europe quadrupled between 2005 and 2007. And the number of investigations undertaken by the U.S. Food and Drug Administration increased by a factor of eight between 2000 and 2006, according to the study, published in the International Journal of Clinical Practice.

The sale of counterfeit drugs has almost doubled in the last five years, and will hit $75 billion in 2010, according to one estimate, making it one of the more lucrative illicit drug markets.

As many as 2.5 million men in Europe may have taken counterfeit sildenafil (Viagra), the study authors stated.

“It’s a very significant problem and I think there are people who are being injured,” said Dr. Ira D. Sharlip, a spokesman for the American Urological Association and clinical professor of urology at the University of California, San Francisco. “The only way to avoid the problem is not to buy on the Internet.”

Viagra-like tablets bought on the Internet aren’t necessarily any cheaper than the real thing, but they do allow buyers to avoid the shame factor often associated with asking for this type of drug.

“The motivation is the anonymity of buying drugs on the Internet. It’s embarrassing to some men to go to a pharmacy and pick up his Viagra prescription, and it’s also embarrassing for some men to go to a doctor and say, ‘I have erectile dysfunction. I need some Viagra,’” Sharlip said.

The problem of fake drugs isn’t limited to impotence treatments. According to the study, two pregnant women died after they were given injections of a counterfeit iron preparation for anemia, and 51 children died in Bangladesh of kidney failure after taking paracetamol syrup that was contaminated with diethylene glycol, which is often used as antifreeze in cars.

So many things can go wrong with Internet purchases.

“The purity of the medication or the quality of the medication is under no sort of scrutiny or any type of oversight to determine if, first of all, it is the correct medication. And second, if it is correct is it in the correct dosage?” said Dr. Michael Chehval, chief of urology at St. Louis University.

Study author Dr. Graham Jackson, a cardiologist at London Bridge Hospital in the United Kingdom, said: “The first danger is people don’t know what’s in it. Some are just talcum powder or brick dust, while some have a bit of Viagra or Cialis and some chemicals that have nothing to do with it. One batch actually contained amphetamine, which is an addictive drug. Tablets are made shiny with road paint or shoe polish. The content of the medication could be anything.”

In 2008, four men in Singapore died after ingesting counterfeit impotence drugs that had been contaminated with a blood-sugar-lowering agent, the study reported.

And bypassing the involvement of a competent doctor means red flags could be missed.

“Erection problems can be an early warning sign of heart disease or diabetes,” Jackson said. “If you do have a problem and don’t see a doctor, diagnosis of those important conditions can be missed. Men with no symptoms at all who get an erection problem usually are an average of three to five years away from a heart attack. Instead of going to the Internet, they should be going to their doctors to find out if they are at risk and to do something about it.”

Problems also can occur when the impotence drugs actually do contain phosphodiesterase type 5 inhibitors (PDE5), the main ingredient in Viagra, as well as vardenafil (Levitra) and tadalafil (Cialis).

“People with underlying heart problems are at risk for cardiac events if they take this class of medication,” Chehval said.

According to the review article, about one-third of men reported sidestepping a health-care professional when buying erectile dysfunction drugs.

“This is a really serious issue. We can fix the erectile dysfunction and we can also fix the chances of getting a heart attack,” Jackson said.

Jackson is editor of the journal and reported multiple ties to pharmaceutical companies, including Pfizer, which makes Viagra. The review article covered more than fifty studies published between 1995 and 2009 and was conducted by British, Swedish and American researchers.

Technorati Tags: buy prescription medications, cialis, erectile dysfunction drugs, fake drugs risks, Levitra, Viagra

Cialis is an oral prescription drug taken by men for treating their erectile dysfunction problems. It has become popular with millions of men who have erectile dysfunction. The popularity of Cialis is largely due to its long lasting effects.

There are many causes of erectile dysfunction in men. Some men may suffer erectile dysfunction due to physical factors and some due to psychological factors. Some men may also have erectile dysfunction problems due to excess intake of medicines for treating medical conditions like high blood pressure or diabetes. These medical conditions can also cause erectile dysfunction in men.

Cialis that was originally available in a need based form, has now been approved in a new lower strength daily dose that can be used as a regular medicine for treating this condition.

Cialis for treating erectile dysfunction

The small daily Cialis dose has been approved by the FDA for men who have erectile dysfunction and expect frequent sexual intercourse with their sex partners. They can have sexual intercourse at least twice a week at any time between the doses. The on demand doses of Cialis are effective only within a narrow time period and so limit the time for sexual activity.

Cialis strengths

The doses of on demand Cialis are 5mg, 10mg and 20mg. But now the small dose of 2.5mg has been approved for daily use. It can be extended to 5mg dose by the physician after examining the medical condition of the patient.

Effects of Cialis

The effects of daily Cialis doses are positive and users do not have to worry about their effectiveness. They can have regular sexual intercourse with their partners. The once daily Cialis dose can be taken without regard to timing of sexual intercourse.

The use of daily Cialis dose helps strengthen erection in men who have erectile dysfunction problems. It blocks an enzyme that slows the process of blood regulation in the penis. It breaks down more slowly than other erectile dysfunction treatment drugs in the body. This is the main reason for its longer lasting effect in the body.

Side effects of Cialis

Men can experience some mild side effects after taking Cialis doses. Some of these include headache, indigestion, muscle aches, nasal congestion, and facial flushing. These side effects may also occur after taking daily doses of Cialis. You should consult a physician if any major complications arise.

Cialis regular and the daily dose are not suitable for men who take any kind of nitrate drugs. This combination can result in drop in blood pressure levels in the body and can be fatal.

Availability of Cialis

Since Cialis is a prescription drug, so it is not available without obtaining a prescription. You need to consult a physician who examines your medical condition and then issues a prescription that allows you to buy once a day Cialis from a pharmacy. It is also available online. But it requires you to do an online consultation from a licensed online clinic to obtain a prescription. You should select a reliable online source whenever you buy Cialis online.

Technorati Tags: cialis, Cialis 10 mg, Cialis 20 mg, Cialis 5 mg, Cialis dose, cialis prescription drug, side effects of Cialis

Cialis, the trademark drug of Lilly Icos can be beneficial to human beings in ways other than curing erectile dysfunction. Clinical researches have found out that tadalafil, the main component of Cialis can help people in reducing their blood pressure, keep a widespread prostrate condition under control and deal with an impending lung disorder. These additional benefits of Cialis have made the future of Lilly Icos brighter.

David Goodkin, the Senior Vice President at Icos stated in a press release that the company is constantly working towards development of the drug for any other potential benefits. Even tadalafil, the active ingredient in Cialis, was earlier developed as angina drug years before its impotency curing properties were realized.

Icos announced that it would utilize the mechanism of Cialis for the effective treatment of hypertension or chronic high blood pressure. Goodkin said there are around 50 million people with hypertension in the United States alone. Though many drugs to cure chronic high blood pressure are available, none of them are free of major side effects. Cialis may prove to be the dream drug, with negligible side effects.

Lilly Icos went ahead with a phase 2 study of Cialis to investigate the effects of tadalafil on persons with hypertension. The result of the study was clinically meaningful. It established that tadalafil showed compatible effects to the other drugs in the market. The only difference came up in the form of side effects. All the other drugs impeded sex, whereas Cialis gave an altogether opposite effect.

Tadalafil can also treat the symptoms of Benign Prostatic Hyperplasia, a common prostate problem. A patient with this problem administered with a dose of tadalafil showed a statistically remarkable improvement. A thorough medical assessment of the patient demonstrated that Cialis can be an effective drug for men with benign prostatic hyperplasia.

Pulmonary arterial hypertension is a rare problem of the lungs, which is characterized by an increased pressure in the arteries of the lungs. People diagnosed with this condition rarely survive for more than three years. It normally occurs in people who are under 30 years of age, generally causing fatigue, shortness of breath and heart failure. The drugs to treat pulmonary arterial hypertension have an adverse effect on the liver. The FDA has already approved sildenafil as a potential drug for this condition without the risk of the harmful side effects. This has heightened the possibilities of tadalafil as a treatment.

Goodkin and other medical scientists in Icos said that many of the erectile dysfunction patients have other health problems that can be cured by Cialis. Biotechnologists are of the opinion that Cialis is one of those few wonder drugs that have multi-beneficial properties. This is certainly good news for Lilly Icos.

Technorati Tags: Benign Prostatic Hyperplasia, cialis, Cialis benefits, Cialis news, ED treatment, tadalafil

(HealthDay News) — A “nanoparticle” topical treatment for erectile dysfunction appears to work well, at least in a study involving rats.

According to the researchers, five of seven rats developed erections after their penises received a coating of a special hybrid of nanoparticles that slowly released nitric oxide (NO), which relaxes cells in the penis to help blood vessels open, bringing in more blood and swelling the tissues.

The rats’ average erectile response to the treatment was about an hour, according to the research team headed by members from Albert Einstein College of Medicine in the Bronx, N.Y.

Erectile dysfunction, which is estimated to affect up to 30 million American men, can range from being able to only briefly sustain an erection to not being able to achieve one at all, according to the U.S. National Institute of Diabetes and Digestive and Kidney Diseases. Several types of oral or injectable medications are currently available to manage the condition.

The study is scheduled to be presented this week in Chicago at the annual scientific meeting of the American Urological Association.

“This is a very interesting concept which has potential to impact treatment of many conditions, including erectile dysfunction, if it can be translated from the animal lab to clinical practice,” American Urological Association spokesman Dr. Ira D. Sharlip said in a news release issued by the organization. “It remains to be seen whether the effect of the nanoparticle technology is a local or a systemic effect.”

More information

The American Academy of Family Physicians has more about erectile dysfunction.

Technorati Tags: American Urological Association, Erectile Dysfunction, erectile dysfunction treatment, topical treatment, topical treatment for erectile dysfunction, treatment for erectile dysfunction