Clinical Trials Demonstrate SOMA 250 mg Efficacy and Favorable Tolerability Profile.

FDA approval of SOMA 250 mg was based on the results from two randomized, double-blind, placebo-controlled, multi-site parallel group studies (MP502 and MP505) which included more than 1,300 patients aged 18 to 65 who suffered from acute painful muscle spasm of the lower back. Results from both studies showed that SOMA 250 mg provided significant and rapid relief of back pain compared to placebo (P = 0.0001) with efficacy comparable to SOMA 350 mg.

Results from the studies also showed that SOMA 250 mg provided efficacy comparable to SOMA 350 mg with a more favorable tolerability profile, resulting in fewer discontinuations due to treatment-related adverse events. In the studies, the discontinuation rate due to adverse events for SOMA 250 mg was comparable to placebo and lower than that for SOMA 350 mg (2% versus 2.7% versus 5.4% respectively). The most common side effects associated with SOMA 250 mg in clinical trials included drowsiness (13%), dizziness (8%) and headache (5%). The most common side effects for SOMA 350 mg included drowsiness (17%), dizziness (7%) and headache (3%).

Soma 250mg dose gets approval.

Swedish speciality pharma company Meda AB has announced its new low dose of Soma (carisoprodol) has been approved by the US Food and Drugs Administration (FDA).

The 250mg dose will be the lowest carisoprodol treatment available, which has been marketed since 1959

Cola may not be so sweet for women's bones, according to new research that suggests the beverage boosts osteoporosis risk.

"Among women, cola beverages were associated with lower bone mineral density," said lead researcher Katherine Tucker, director of the Epidemiology and Dietary Assessment Program at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University.

There was a pretty clear dose-response, Tucker added. "Women who drink cola daily had lower bone mineral density than those who drink it only once a week," she said. "If you are worried about osteoporosis, it is probably a good idea to switch to another beverage or to limit your cola to occasional use."

The report was published in the October issue of the American Journal of Clinical Nutrition.

About 55 percent of Americans, mostly women, are at risk for developing osteoporosis, according to the National Osteoporosis Foundation.

In the study, Tucker's team collected data on more than 2,500 participants in the Framingham Osteoporosis Study, averaging just below 60 years of age. The researchers looked at bone mineral density at three different hip sites, as well as the spine.

They found that in women, drinking cola was associated with lower bone mineral density at all three hip sites, regardless of age, menopause, total calcium and vitamin D intake, or smoking or drinking alcohol. Women reported drinking an average of five carbonated drinks a week, four of which were cola.

Bone density among women who drank cola daily was almost 4 percent less, compared with women who didn't drink cola, Tucker said. "This is quite significant when you are talking about the density of the skeleton," she said.

Cola intake was not associated with lower bone mineral density in men. The findings were similar for diet cola, but weaker for decaffeinated cola, the researchers reported.

The reason for cola's effect on bone density may have to do with caffeine, Tucker said. "Caffeine is known to be associated with the risk of lower bone mineral density," she said. "But we found the same thing with decaffeinated colas."

Another explanation may have to do with phosphoric acid in cola, which can cause leeching of calcium from bones to help neutralize the acid, Tucker said.

One expert agrees that women should reduce the amount of cola they drink.

"I would expect this finding," said Dr. Mone Zaidi, director of the Mount Sinai Bone Program at Mount Sinai School of Medicine, in New York City. "It's probably a caffeine-related problem."

Women should limit their caffeine intake, Zaidi said. "Caffeine interferes with calcium absorption, which results in less bone formation," he said.

This can be a problem for younger women who never develop peak bone density, Zaidi noted. "Younger women who have a lot of coke will not form bone to an extent their peers would; so, years later, in menopause, they are going to be disadvantaged," he said.

Propecia Increases Hair Weight And Quality, Improves Scalp Coverage: Presented at ADV

AMSTERDAM, THE NETHERLANDS -- September 29,1999 -- The first-ever pill for male hair loss holds new promise for millions of men, following the results of a new study.

The treatment, Propecia (finasteride 1mg) has been proven to significantly increase hair weight and improve hair quality - making hairs thicker and longer in addition to increasing their number. This improvement in hair quality is good news for men who are concerned about their hair loss because improved hair quality provides improved scalp coverage.

Dr. Vera Price, of the Department of Dermatology, University of California, San Francisco, CA, presented findings from the Hair Weight Study for the first time today at the 8th European Academy of Dermatology and Venereology meeting, in Amsterdam, The Netherlands.

Results from a study involving 66 men taking either one Propecia tablet daily or placebo showed that after 96 weeks of treatment, Propecia increased hair growth on the scalp by improving the weight of hair.

Furthermore, the beneficial effects of Propecia continued throughout the two-year study period. The difference in total scalp hair coverage between the men taking Propecia and those taking placebo became greater as the study progressed - that is, men taking Propecia continued to grow more hair, thicker hair and longer hair, while those taking placebo were gradually losing hair.

The net improvement in hair weight between men treated with Propecia compared to those treated with placebo was 35.8 percent (P<0.001) after 96 weeks.

"The increase in hair weight produced by treatment with finasteride 1mg as demonstrated in this latest study, reflects the beneficial effects of the drug on the key aspects of hair quality. These aspects include increased hair number, shown in previous studies as well, and additionally improved hair thickness and hair length," said Dr. Price.

Hair weight is a quantitative, reliable measure of hair growth and provides an integrated measure of changes in hair growth rate and total hair mass (length, hair thickness and hair number). Hair growth rate and total hair mass determine hair quality, and improved hair quality provides improved coverage of the scalp. Therefore, hair weight is an accurate way to measure the cosmetic benefits of treatment for male pattern hair loss.

By using phototrichogram methodology it has been shown that Propecia actually stimulates resting hair follicles to grow, thereby increasing the total number of growing hairs at any one time (Van Neste, et al.). These additional growing hairs observed in treated patients have now been shown to grow longer and thicker, signifying an improvement in hair quality and an improvement in scalp coverage.

Evidence of the cosmetic benefits of Propecia can be fully substantiated by worldwide clinical trial results. Propecia after two years of treatment has been shown to prevent further hair loss in five out of six men treated (83 percent, v. 28 percent placebo) and to re-grow hair that visibly increased scalp coverage in two out of three men (66 percent, v. 7 percent placebo).

The world's first hair loss pill for men is only available by prescription from a doctor and has proven to be well tolerated in clinical trials. Drug-related adverse events occurred in less than 2 percent of men taking Propecia. These side effects went away in all men who discontinued therapy and also disappeared in most men who chose to continue taking Propecia.

Propecia was first launched in the United States in 1997. It is currently available in most European countries and 22 other countries worldwide.

Propecia is administered as a 1mg oral tablet once daily. It is not indicated for use in women or children. It is a product of Merck, Sharp & Dohme.

Dreams and Erections

The average male has four to eight spontaneous erections every night while he sleeps. They usually occur during the REM stage, when dreaming is most common.

When a doctor wants to know whether a patient's difficulty achieving an erection is due to physical or mental reasons, one way to find out is to fit the patient's penis with a sensor and see whether or not the patient's dream erections are working properly. If not, the problem is probably physical.

History of Viagra

Viagra was initially developed a heart condition called angina, during the testing period for this drug it was found to give an erection to men. The drug was patented in 1996, approved in 1998 making viagra the first official drug to treat erection problems and being made available for sale later that year. The success of this drug is over whelming. You can get viagra on perscription from your doctors or on numerous websites after consultation (a mere questionaire). The fact is, it has improved the sex lives of millions men and women around the world. Annual sales of Viagra in the period 1999 - 2001 exceeded .750,000,000.

It was first thought that Viagra would lead to a drop in the market for traditional remedies which came from specific body parts of endangered species. This is highly unlikely as the traditional remedies is a treatment not just for erectile dificinency e.g. the Rhinoceros horns are used for high fever. Further on it is unclear that natural remedies will be able to compete with Viagra, due to its aphrodisiac properties.

Since Viagra's release, there has been an increase in 'fake viargra' being sold on the interne which looks like viagra (blue diamond pill) will the companies name, Pfizer engraved on it. These have proven to be dangerous and you must be careful where you buy viagra. Check out our purchasing viagra guide.

Pfizer's worldwide patents on Viagra will expire in 2011 - 2013. The UK patent held by Pfizer on the use of Viagra as treatment of impotence has been invalidated in 2000 because of obviousness; this decision was upheld on appeal in 2002.

Viagra and the Mountains

Researchers Say the Drug May Help Performance at High Altitude, Help Soldiers Fight in Afghanistan

As the commercials continually remind us: Viagra is all about performance.
Now it turns out, that's not just referring to in the bedroom.
Researchers say the drug, approved for erectile dysfunction, could eventually help some athletes train at high altitudes and soldiers fight in the mountains of Afghanistan.
In a study at Stanford University, some volunteers riding stationary bicycles and breathing through masks to simulate the low oxygen conditions found at 12,700 feet, improved their times for six kilometers by an average of 39 percent after taking Viagra.
The drug, which became an instant blockbuster for Pfizer in 1998, works by causing blood vessels to relax - not only in the penis but in the lungs.
Last year, the company won approval for the drug, also known as sildenafil, to treat a medical condition called pulmonary hypertension, or high fluid pressure in the lungs. Pulmonary hypertension is also one of the effects of exercising in oxygen-poor environments such as high altitudes.
"It provides a pretty clear advantage to some people," said Annie Friedlander, the senior author of the study, which appears in the Journal of Applied Physiology.
It does not help everyone. Only four of the 10 riders saw their times improve - 10 minutes, 48 seconds with Viagra compared to 15 minutes when they took a placebo.
Researchers are not certain why only some volunteers responded to the drug, but they noticed that they were the ones whose times had suffered the most at high altitudes. Viagra, it seems, allowed them to make up the performance they had lost.
None of the riders saw any improvement from the drug at sea level, and none reported an erection during the trials.
The next step: The U.S. military plans to test Viagra, at high altitude, on about a dozen soldiers later this summer.

Women can benefit from Viagra

Viagra may help some women
Women can benefit from taking the impotence drug Viagra, scientists have claimed.

Research by a team from the University of Boston has found that the drug can benefit women who have had a hysterectomy or who have gone through the menopause.
In both cases, women experience a loss of production of female hormones that can lead to sexual problems, such as loss of sensation and lubrication.
Dr Jennifer Berman tested the drug on 17 women who had either had a hysterectomy or gone through the menopause.
Each woman got either Viagra or a dummy pill, and three months later the women who got Viagra were switched to a placebo and the women who had been given sugar pills got Viagra.
Dr Berman and the patients did not know which woman got which pill until the end of the study.
Viagra, whose technical name is sildenafil, works by increasing the effects of nitric oxide, a common body chemical, which in turn gets more blood flowing into the genitals.
Dr Berman, who will present her findings to a meeting of the American Urological Association, said: "Sildenafil did appear to significantly increase blood flow and pH and pH is an indicator of lubrication."
"Subjectively, with regard to lubrication, sensitivity, the ability to have orgasm, and satisfaction, the women noted a significant difference."

Emotional problems
Dr Berman has carried out another study at Boston University with 48 women, aged 22 to 71.
While not so carefully controlled - the women all got Viagra and knew it - there was a statistically significant difference.
She said: "It does appear to be Viagra because there are physiological changes that can't be faked."
However, Viagra failed to work for women in the second study who had psychological problems with sex.
These included poor body image, a history of sexual abuse, or marital trouble.
Dr Berman said: "Those women don't respond to Viagra or any drug.
"Although there are physiological, medical reasons why women have sexual complaints, there are emotional and relational consequences to sexual dysfunction that are relevant to women."
She added that it was more difficult to tell if a woman had sexual problems.
"While men can define their sexual function in terms of rigidity, for women it doesn't work that way," she said.
Pfizer, the manufacturers of Viagra, say that seven million prescriptions have been written for the drug worldwide since its launch last year.

Viagra improves sex for postmenopausal women

The findings come from a study led by Jennifer R. Berman, MD and Laura A. Berman PhD.
Pfizer Inc (maker of Viagra) funded the study which monitored 200 postmenopausal women with FSAD (female sexual arousal disorder).
100 women received Viagra while the other half were on a placebo. More women on Viagra (than the placebo) reported better sexual (more sexual) satisfaction. Some of the women on the placebo also reported an improvement (lower number than those on Viagra).
All the women who had hypoactive sexual desire disorder (HSDD) as well as FSAD reported no improvement at all.
The most common problem for women with FSAD is genital blood flow (which Viagra seems to be able to help). Women with HSDD have underlying emotional or relationship problems which lead to a reduction in sexual desire.
'Unresolved emotional or relational issues should be addressed before beginning medical therapies,' Berman her colleagues said (December issue of The Journal of Urology).
Those in the study included women who were postmenopausal (or had had a hysterectomy), aged from 30-71 (average age 51).
Two questions (asked after the women had taken the Viagra of Placebo) the team focussed on were:
1. After taking the study medication, the sensation/feeling in my genital (vagina, labia, clitoris) area during intercourse or stimulation seemed to be: (a) more than before, (b) less than before, or (c) unchanged.
2. After taking the study medication, intercourse and/or foreplay was (a) pleasant and satisfying; better than before taking the study medication; (b) unpleasant; worse than before the study medication; (c) unchanged; no difference; or (d) pleasant but still not like it used to be or I would like it to be.

Regarding Question 1 the results were:
Placebo patients: 44% reported an improvement
Viagra Patients: 57% reported an improvement

Regarding Question 2 the results were:
Placebo patients: 26% reported an improvement
Viagra patients: 42% reported an improvement

However, of the patients (on Viagra) with sexual arousal disorder who did not have HSDD 68% reported an improvement on the first question (eight times more than women without HSDD who were on the placebo).
In addition, of the patients (on Viagra) with sexual arousal disorder who did not have HSDD, 50% said there was an improvement in question 2 (11 times more than the non-HSDD women on the placebo).
The authors also said that women who respond to Viagra may need to have normal levels of oestrogen and testosterone. For many postmenopausal women, that may mean menopausal replacement therapy. In the present study, the women had normal hormone levels or were receiving menopausal replacement therapy.

Cialis aids prostate cancer sex function

ROTTERDAM, Netherlands, Oct. 2 (UPI) -- Dutch scientists say they have found a drug usually prescribed for erectile dysfunction in men increases the sexual function of prostate cancer survivors.
Prostate cancer is the most commonly diagnosed cancer in men. But after treatment, some patients report trouble achieving an erection sufficient for sexual activity -- a medical condition called erectile dysfunction or ED. In the Dutch study, physicians wanted to test whether the drug Tadalafil, which sells under the brand name Cialis, would help prostate cancer survivors with ED who were treated with three-dimensional conformal radiation therapy.
In what is believed the first randomized trial of its type, successful intercourse was reported in 48 percent of the survivors who took Tadalafil versus 9 percent of the men who were given placebo. There was also a reported improvement of the quality of erections in 67 percent of the patients, versus 20 percent of the placebo group.
The research conducted at the Erasmus MC-Daniel den Hoed Cancer Center in Rotterdam is detailed in the International Journal of Radiation Oncology Biology Physics.

Viagra may treat 'cold hands' syndrome

Study: Erectile dysfunction drug relieves symptoms of Raynaud's
MEDPAGE TODAY
Little Blue Pill May Put Brakes on Some Heart Disease
Many men use Viagra (sildenafil) to speed up their sex lives. Now it seems that if some research pans out the little blue pill may also wind up slowing down some forms of heart disease.

NEW YORK - Viagra (sildenafil) relieves the symptoms and improves the circulation of patients with Raynaud's phenomenon that does no response to conventional therapy, German investigators report. In patients with ulcers on their fingers or toes, the treatment leads to healing.
Viagra, developed to treat of male erectile dysfunction, is a phosphodiesterase (PDE)-5 inhibitor that affects very small blood vessels. Studies have shown it improves circulation in other conditions, such as coronary artery disease.
Raynaud's phenomenon is characterized by spasms in the small blood vessels of the hands and feet in response to cold or stress, resulting in poor circulation and pain. The disorder can also lead to ulceration or tissue death in the toes and fingers.

Raising the issue of Viagra costs- who should pay?

Imagine a new drug that could restore some lost physical ability, at least for a few hours. Then imagine that this new drug costs $10 a dose, and could be used by millions of people. Viagra fits this description, of course, and its magic is to restore virility to impotent men-albeit for a few hours at a time. Viagra is predicted to be a billion-dollar seller for Pfizer in its first year of sales, and that means someone is paying for all those $10 pills.
Some managed care companies have announced that they will not pay for Viagra based on its high cost, but it is hard to imagine them making a similar decision about an equally expensive drug that cured a specific type of cancer or reversed paralysis. Would there be hesitation to cover a drug that would restore the use of paraplegics' legs, even if each pill cost $10 and its effects diminished after a few hours? No doubt we would consider it a miracle and a bargain. So why not Viagra?

Who needs lifestyle drugs?
Part of the motivation for denying payment for Viagra is the perception that it doesn't cure or even treat illness or disease, and that the functions it temporarily restores are not life-threatening or critical enough for it to make sense to pay for it. Since the group of patients who could use Viagra are a fast growing part of the male population (as our population ages), managed care companies see it as a bank breaker. A pill to temporarily "cure" paralysis would be a miracle to those who would use it, but their numbers would be thankfully small. That Viagra is beneficial for so many men is exactly why payers are reluctant to cover it.
The future will likely offer many new drugs like Viagra: expensive drugs that have lifestyle benefits without actually curing an illness or disease. We might be comfortable drawing a line between paying for curative treatments and those that are "cosmetic," and asking individuals to pay for cosmetic treatments themselves. So is Viagra cosmetic, curative, or both?

Paying for lifestyle treatments
Fertility treatments like in-vitro fertilization (IVF) are not usually covered by insurance because it is considered medically unnecessary. But it improves life in a way that restores a normal function- offering some infertile women the possibility of having a child. Neither Viagra nor IVF are like cosmetic surgery, but both can be used in a "cosmetic" way by people who don't have a medical need for them: IVF for women who want to select specific traits for their children, and Viagra for men who think it will add vitality to their sex lives.
The difference between using drugs or treatments for medical reasons and cosmetic purposes offers a way to decide which deserve coverage. We should feel even less worried about denying coverage for cosmetic uses when the drug is affordable to most everybody.

Protecting access in the future
As we live longer and healthier lives, our health care needs will become more about treating chronic effects to our health, such as Alzheimer's disease or impotence, than about treatments for heart attacks in middle age. It is important that we protect our access to drugs and treatments that improve our health by protecting normal functions. The key will be determining what counts as normal, and when the same treatments are merely enhancements. The case of Viagra represents only the beginning of what will be more difficult decisions about who pays for the promising treatments of the future.