Levitra shows fastest ever response time demonstrated of any PDE5 treatment tor erectile dysfunction

Treatment with Levitra can result in an erection in just 10 minutes in some men and in most men within 25 minutes. A new clinical study that measured the speed with which men with ED can achieve an erection demonstrated that Levitra has the most rapid onset to date of any PDE-5 inhibitor on the market. The study will be presented at the 7th European Federation of Sexology (EFS) congress in Brighton this week.

The study (called ONTIME - ONseT of Vardenafil In Men with Erectile Dysfunction), presented in the UK, showed that Levitra had a statistically significant response superior to placebo at 10 and 11 minutes with 10 mg and 20 mg doses, respectively. The ONTIME study assessed the earliest time elapsed from dosing to attainment of an erection adequate for penetration leading to completion of successful intercourse (as measured by SEP3 ).

"The results of the ONTIME study show Levitra demonstrated the fastest onset of action to date, meaning men can be confident and engage in a satisfying sexual experience when they want to," says Professor Francesco Montorsi, study investigator and Associate Professor of Urology at the Universita' Vita Salute San Raffaele in Milan.

In another study presented at the congress, speed of action was an essential attribute of ED treatment, more so than duration, according to the largest published survey of male sexuality (Men's Attitudes to Life Events and Sexuality [MALES]). This study found that in men with ED, rapid onset was considered important irrespective of age, while long duration of action became less important as men aged. 1

"The combined results of these studies demonstrate that men value a rapid onset of action and that Levitra offers patients what they want," concluded Professor Montorsi.

The MALES study included interviews with 2912 men, aged 20-75, from 8 countries (UK, US, Germany, France, Italy, Spain, Mexico and Brazil).

The ONTIME study was conducted in 724 patients in 80 centres in Europe and North America (8 countries). It was a randomised, double blind, parallel group, multicentre trial, which studied men with ED (baseline IIEF-EF score of 13.0 [moderate severity], ITT population ). The study design included a four-week unmedicated run-in period, followed by a four-week treatment with Levitra 10 mg, 20 mg or placebo, taken on demand. The first four doses were used to determine the earliest time of onset.

In the ONTIME study, the most common drug-related adverse events were generally mild to moderate and included headache, flushing, rhinitis and dyspepsia.

Notes to Editors

Erectile dysfunction (ED) is defined as the consistent or recurrent inability of a man to attain and/or maintain a penile erection sufficient for sexual performance. 2

It is estimated that some degree of ED affects more than one half of all men over the age of 40 and that worldwide an estimated 152 million men suffer from ED. The number of men with ED is expected to more than double to 322 million by 2025. 3,4 , Despite the high prevalence of sexual dysfunction, experts estimate that only 15-20 percent of men with ED are currently treated. 5

Phosphodiesterase type 5 (PDE-5) is the predominant enzyme found in human penile erectile tissue and is associated with erections. PDE-5 inhibitors typically work by blocking this enzyme to enhance or prolong the erectile response.

Levitra was specifically selected for development as an ED therapy because of its in vitro potency and high selectivity for the inhibition of the PDE-5 enzyme.

Levitra 5, 10 and 20 mg doses are contraindicated in men taking nitrates and nitric oxide donors (a group of medications used to treat angina pectoris, or chest pain), in men concomitantly using HIV protease inhibitors (such as indinavir and ritonavir), and in patients with a known hypersensitivity to any component of the tablet. Please refer to individual country labels for other important prescriber information.

Levitra, researched and discovered by Bayer AG, is marketed by Bayer and GlaxoSmithKline plc (GSK) through a worldwide co-promotion and co-development agreement. Levitra was approved on 6 March 2003 by the European Commission based on the quality, safety and efficacy data submitted. These data included results from more than 3,750 men representing a broad patient population. The US Food and Drug Administration (FDA) approved Levitra for the treatment of ED on 19 August 2003.

About Bayer Pharmaceuticals Corporation

Bayer Pharmaceuticals Corporation is part of the worldwide operations of Bayer HealthCare, a subgroup of Bayer AG. Bayer HealthCare is one of the world's leading innovators in the health care and medical products industry.

Bayer HealthCare combines the global activities of the business groups of Bayer AG in the fields of Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. More than 34,000 employees support the worldwide operations of Bayer HealthCare.

Our work at Bayer HealthCare is to discover and manufacture innovative products for the purpose of improving human and animal health worldwide. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.

About GSK

GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer.

Vivanza is the vardenafil brand marketed by GSK in Italy.

For further information about ED, please visit: www.AllAboutED.com.

*Sexual Encounter Profile (SEP): A questionnaire containing seven patient diary questions that allow patients to record sexual events. The most pertinent and widely used SEP questions to diagnose and evaluate ED treatments are:

SEP2 Patient Diary: Were you able to insert your penis into your partner's vagina?

SEP3 Patient Diary: Did your erection last long enough to satisfactorily complete sexual intercourse?

International Index of Erectile Function (IIEF): One of five areas of the International Index of Erectile Function (IIEF) used to measure quantity and quality of erections. It includes questions about the ability to achieve and maintain erections to the completion of sexual intercourse.

The intent to treat (ITT) population included those patients who met the following criteria:

Valid for safety

Received at least one dose of study medication

Answered one valid diary after randomisation

REFERENCES

1 Eardley I, Rosen R, Fisher W, Niederberger C, Sand M.Rapid Onset vs. Long Duration of Action: Effect of Age and Comorbidity on Attribute Ranking in The Men's Attitudes to Life Events and Sexuality (MALES) Study. To be presented at the 7th Congress of the European Federation of Sexology 12-16 May 2004, Brighton, UK.

2 Jardin A, Wagner G, Khoury S, et al. Recommendations of the 1st International Consultation on Erectile Dysfunction. Co-sponsored by the World Health Organization (WHO), International Consultation on Urological Diseases (ICUD) and Societe Internationale d'Urologie (SIU) and held July 1-3, 1999, Paris. 2000, p.713.

3 Feldman HA, Goldstein I, Hatzichristou DG, et al. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61.

4 Aytac IA, McKinlay JB, Krane RI. The likely worldwide increase of erectile dysfunction between 1995 and 2025 and some possible policy consequences. BJU Int 1999; 84:50-56. 5 Southgate J. New rivals to Viagra expand the market. Scrip Magazine, 2002.

Viagra And Cialis May Be Linked Increased Risk Of Optic Nerve Damage For Men With Cardiovascular Problems

Viagra and Cialis, the drugs used to treat impotency, may be associated with an increased risk of optic nerve damage in men with a history of heart attack or high blood pressure, suggests a small study in the British Journal of Ophthalmology.

Healthcare professionals prescribing these drugs should warn patients of the potential risk, say the authors.

The findings are based on 76 men attending one US specialist eye clinic. Half the men had optic nerve damage, diagnosed as non-arteritic anterior ischaemic optic neuropathy (NAION).

NAION is the most common form of optic nerve damage in older US adults, with up to 6000 people developing the condition every year. One in four will go on to develop it in both eyes.

The other half, who were randomly selected and did not have the condition, were used as a comparison group.

All the patients were asked about their lifestyle, including smoking and alcohol intake, whether they had been diagnosed with heart disease, diabetes, or high blood pressure and prescribed treatment for these conditions. They were also asked if they had been prescribed Viagra and Cialis for erectile difficulties.

The two groups were similar in terms of age, race, and lifestyle, and men with optic nerve damage were no more likely to have taken the impotency drugs than men in the comparison group.

But men who had had a heart attack were 10 times more likely to have optic nerve damage if they had taken Viagra or Cialis before their diagnosis.

Men with high blood pressure were also more likely to have optic nerve damage if they had taken these drugs, although this was not statistically significant.

The authors caution that their study is small, but suggest that the drugs may reduce the blood flow to the anterior optic nerve, resulting in tissue damage. The drugs may heighten the risk of NAION in those with vascular disease, who are already more susceptible, they explain.

Any patient who has endured a sudden severe loss of vision, and is prescribed Viagra or Cialis, should inform their healthcare practitioner first, say the authors.

An accompanying editorial points out that some patients with impaired eyesight as a result of NAION have reportedly decided to sue Pfizer, the manufacturers of Viagra.

The editorial goes on to say that Pfizer have stated that there were no reports of NAION in the trials of the drug carried out before it was licensed, and that a greater number of cases related to this type of drug would have been reported by now if the association was anything other than coincidental.

But the editorial says that doctors may not be asking patients diagnosed with NAION whether they take Viagra or Cialis.

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.

FDA Fast Track Designation For Tramadol ER In Painful HIV-associated Neuropathy, TheraQuest

TheraQuest Biosciences, a development stage pain management company today announced that the U.S. Food and Drug Administration (FDA) has designated as a Fast Track product the Company's proprietary, abuse deterrent Tramadol Extended Release (ER) for the treatment of painful HIV-associated neuropathy.

Fast Track designation provides expedited regulatory review for new drugs demonstrating potential to address unmet medical needs for the treatment of serious or life-threatening conditions. Under Fast Track, TheraQuest is now eligible to submit a new drug application (NDA) for Tramadol ER on a rolling basis, allowing the FDA to review sections of the NDA in advance of receiving TheraQuest's full submission.

According to the FDA, Tramadol ER was designated a Fast Track product both because of the seriousness of painful HIV-associated neuropathy and because Tramadol ER demonstrates the potential to provide a therapeutic benefit. There are currently no approved therapies for patients with painful HIV- associated neuropathy.

"Tramadol ER's fast track status underscores the urgency of developing new treatments for patients with painful HIV-associated neuropathy and the potential of Tramadol ER to improve the quality of life of patients with this devastating disease," said Najib Babul, PharmD, President and CEO of TheraQuest. "We look forward to working closely with the Division of Anesthetic, Analgesic and Rheumatology Products at FDA to expedite the development of Tramadol ER for painful HIV-associated neuropathy," added Babul. About Tramadol ER (TQ-1017)

TheraQuest's Tramadol ER (TQ-1017) is a proprietary, extended release once-daily abuse deterrent formulation of tramadol. It demonstrates more robust in vitro abuse deterrent properties than either controlled release oxycodone or marketed Tramadol ER formulations. It is exceedingly difficult to extract the active drug from the formulation using common solvents. It also cannot be crushed for inhalation to obtain rapid euphoria. Without a secure release once-daily tramadol, rapid absorption from intentional or inadvertent crushing has the potential to deliver a massive dose all at once and produce neurological toxicity, including agitation, seizures, coma and respiratory failure.

TheraQuest has been granted 7-years market exclusivity for Tramadol ER by the FDA Office of Orphan Products Development for the "management of post- herpetic neuralgia" and for the "treatment of painful HIV-associated neuropathy." Orphan product designation provides seven years of market exclusivity, 50% R&D Tax Credits, exemption from FDA Prescription Drug User Fee and access to research grants from the Office of Orphan Products Development.

TheraQuest has an open IND in the United States and has recently completed a Phase I study evaluating the pharmacokinetics of once-daily Tramadol ER compared to short-acting tramadol (Ultram(R)), which is dosed every four to six hours.

About TheraQuest

TheraQuest Biosciences is a private, development-stage pain management company building a diversified portfolio of pharmaceutical products to address a critical area of unmet medical need. Despite their limitations, current treatments for acute and chronic pain yield worldwide sales in excess of $25 billion. The TheraQuest team has contributed to the development of numerous analgesics approved in the U.S. over the past 20 years. TheraQuest's strategy is to use its expertise to identify, develop and commercialize product candidates with strong market potential that have lower development costs and reduced regulatory risk than new chemical entities. TheraQuest is headquartered in Blue Bell, Pennsylvania.

TheraQuest is funded in part by BioAdvance, the Biotechnology Greenhouse of Southeastern Pennsylvania and Ben Franklin Technology Partners of Southeastern Pennsylvania. Additional information is available at http://www.theraquestinc.com.

TheraQuest Biosciences, LLC

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.