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Sciele Pharma, Inc. today announced that Plethora Solutions Holdings PLC has completed its European Phase III study of PSD502 for the treatment of premature ejaculation (PE) in Europe. The study was initiated in December 2007 and these results from the blinded study are expected in the fourth quarter of 2008.

In recently published results from a Phase II study, PSD502 was shown to increase ejaculation latency time significantly when compared with placebo (Dinsmore W et al BJU Int 2007; 99: 369-35).

There are two pivotal PSD502 studies running in parallel, one in North America and one in Europe. Each is a multi-centre, randomized, double blind, placebo-controlled efficacy study recruiting a total of 540 patients across both studies. 275 patients will have completed the blinded phase of the study across 32 investigational centers in 4 countries across Europe. Of these, 265 patients have entered an optional 5 month open-label study.

Recruitment in the equivalent study in the U.S. is ongoing and data from the two studies will be combined for submission for regulatory approval in the U.S. and Europe. A new drug application (NDA) for PSD502 is expected to be submitted to the FDA in the first half of 2009.

In May 2007, Sciele signed an exclusive licensing agreement with Plethora Solutions to market PSD502 in the U.S.

Larry Dillaha, M.D., Chief Medical Officer of Sciele Pharma, said, "We are pleased with the progress Plethora has made with the development of PSD502, which addresses an unmet medical need that affects a significant number of adult males in all age groups."

Dr. Mike Wyllie, CSO of Plethora, commented, "We are delighted to have completed this arm of the Phase III study. The willingness of patients to enter the open-label study is most encouraging as is the low dropout rate throughout the trial. The speed at which recruitment was completed, given the stringent entry criteria, confirms both the number of PE patients in the general population and their willingness to seek treatment."

http://www.sciele.com

The American Heart Association says heart patients are particularly vulnerable to depression and should be screened, and if necessary treated, to improve their recovery and overall health.

A report by researchers at Yale School of Public Health says depression and heart disease appear to be very much intertwined and the heart cannot be treated in isolation from the patient's mental health.

Dr. Judith H. Lichtman, co-author of the report who is an associate professor of epidemiology at Yale, says by understanding the prevalence of depression and learning more about the subgroups of heart patients at particular risk of depression, an understanding can be gained into the best ways to recognize and treat it.

The statement is the first of its kind on the link between heart disease and depression and it has the endorsement of the American Psychiatric Association and it recommends: -

• Routine and frequent screening for depression in patients with chronic heart disease in a variety of settings, including the hospital, physician's office and cardiac rehabilitation center.

• Help for patients with positive screening results by a professional qualified to diagnose and manage treatment for depression.

• Careful monitoring of patients to ensure adherence to their treatment plan.

• Coordination between health care professionals treating patients with combined medical and mental health diagnoses.

The researchers say while there is no evidence that screening for depression leads to improved outcomes for people with cardiovascular complications, depression is linked with increased morbidity and mortality, lower rates of cardiac rehabilitation and poorer quality of life.

It seems that depression is about three times more common in people with heart complications than in the general population and as many as 20% of heart patients meet the criteria for major depression.

Research suggests that younger women in particular may be at high risk and it is recommended that heart patients initially be evaluated with a simple two-item assessment and if even one of the questions generates a "yes" response, it is recommended that a more in-depth screening be done with a total of nine questions.

Heart patients found to be suffering from depression can benefit from a number of treatment options, including behavioural therapy, physical activity, cardiac rehabilitation, antidepressant drugs, or combinations of these treatments.

The Association of Public Health Laboratories (APHL) collaborated with the Centers for Disease Control and Prevention (CDC) in the development of a new test for influenza, which received 510(k) clearance today by the Food and Drug Administration (FDA).

The test can accurately detect and identify all commonly circulating human influenza viruses as well as avian influenza A (H5N1) viruses. It operates using PCR (polymerase chain reaction), a highly sensitive laboratory method, and can produce results within four hours.

This new PCR test will help standardize influenza virus testing and sub-typing in the country. FDA clearance of the test will now allow CDC's PCR reagents to be distributed to qualified laboratories for diagnosing influenza using an Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument that was concurrently cleared by FDA. This should help to ensure the accuracy of influenza test results among the different laboratories that conduct sophisticated influenza testing.

APHL member laboratories in Virginia, Iowa, California, Massachusetts, Wisconsin and Washington State conducted clinical trials of the new PCR test. The results from the clinical trials confirmed the high sensitivity and specificity of the test, paving the way for FDA clearance.

"The partnership between CDC, APHL and participating state laboratories has strengthened our national capability to monitor and detect influenza viruses," said Rosemary Humes, senior advisor for scientific affairs, Association of Public Health Laboratories. "This is a positive development for public health laboratories, which provide the backbone for influenza surveillance in the US, and for the American public."

Application of the test to detect an emergent influenza virus would be especially important in the early stages of a pandemic when quick detection of a pandemic virus could help government officials determine when to begin containment strategies as well as life-saving mitigation strategies, such as closing schools, cancelling social gatherings and informing businesses to begin work-at-home policies.

"Public health laboratories must be able to detect a broad range of influenza viruses -- not just those commonly circulating," said Frances Downes, DrPH, president of APHL and director of Michigan's public health laboratory. "Influenza viruses mutate and migrate, rendering some tests ineffective as the virus evolves. This test gives the speed and precision we need to detect and respond effectively to novel influenza viruses."

The Association of Public Health Laboratories is a national non-profit dedicated to working with its members to strengthen laboratories with a public health mandate. By promoting effective programs and public policy, APHL strives to provide laboratories in public health with the resources and infrastructure needed to protect the health of US residents and to prevent and control disease globally.

http://www.aphl.org

The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years.

The contract is the cornerstone of the FDA's Information Technology for the 21st Century (ICT21) bioinformatics initiative, an extensive IT modernization program encompassing data management, data warehousing, IT infrastructure and IT security.

"This contract sets the stage for the FDA to have IT to acquire, analyze and act on data critical for import protection, food protection and medical product safety plans," said Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs. "We are creating a high-tech, efficient, data management system designed to meet the needs of those who must accomplish our mission -- protecting and promoting the health of the American public."

The contracts, with a minimum value of $25,000 in orders per contractor, were awarded to: Buccaneer, of Warrenton, Va.; Computer Sciences Corporation, Rockville, Md.; Dynanet, of Elkridge, Md.; Electronic Data Systems, Herndon, Va.; General Dynamics, Fairfax, Va.; Human Touch, McLean, Va.; IDL-Pragmatics, Vienna, Va.; Interactive Technology Solutions, Silver Spring, Md.; Telesis, Rockville, Md.; and Unisys, Reston, Va.

The ten contractors will compete for data information technology task orders through this contract. The FDA has awarded three task orders under the ICT 21 contract for the design and migration of all systems applications to two new data centers, which will be the cornerstone of the FDA IT infrastructure and bioinformatics modernization for the next decade. The three task orders were awarded to:

• IT Solutions (Task Order 1 - funded initially at $3,000,000) provides the design and implementation as well as migration of existing FDA applications to the newly configured White Oak Data Center, which will support all FDA test and development applications.
• Buccaneer (Task Order 2 - funded initially at $3,000,000) provides the operations and maintenance of the White Oak Data Center.
• EDS (Task Order 3 - funded initially at $12,000,000) provides the design, implementation, migration and operations and maintenance of existing FDA applications to a Contractor Owned Contractor Operated hosted data center for FDA production operations.

All FDA software applications and hosting operations will transition to the new data centers over a two-year period. The resulting enhanced computing power and greater responsiveness will provide the FDA with the tools it needs to ensure that all products reaching the American public are safer and more effective.

http://www.fda.gov

Researchers at NorthShore University HealthSystem (NorthShore) and Northwestern University have discovered that fiber optic technology can for the very first time effectively measure blood levels in the colonic lining (mucosa) in humans, thus having potential applications for analyzing risk of colon cancer. The study appears in the October 2008 issue of Gastroenterology, the official journal of the American Gastroenterological Association (AGA) Institute.

The study used fiber optic technology to map microvascular blood content in patients during colonoscopy. The results provide the first indication that the early increase in blood supply (EIBS) is detectable in humans and that a high blood level mirrors proximity to neoplasia (process of tumor formation). The findings also suggest that this technology could be a valuable screening tool for enhancing polyp detection and could lead to improvements in colon cancer prevention.

"Our premise is that since the lining of the large intestine - rectum and colon - is contiguous, if you see an abnormality in one part of the colon, then somewhere else in the colon you have a higher likelihood of harboring an adenoma [benign tumor] or carcinoma [malignant tumor]," said Hemant K. Roy, M.D., director of gastroenterology research at NorthShore University HealthSystem and the study's principal clinical researcher. "EIBS strengthens our premise thanks largely to the unique and accurate ability of Four Dimensional Elastic Light Scattering Fingerprinting (4D-ELF)."

This state-of-the-art light probe was developed by Vadim Backman, professor of biomedical engineering at Northwestern University's McCormick School of Engineering and Applied Science. It utilizes a revolutionary light scattering technology that can detect subtle abnormal changes in cells lining the colon long before those changes can be seen under a microscope, and even before polyps form.

"It's fascinating," said Roy, "to very precisely know that you're looking at the most superficial layer of tissue - which is where all polyps and cancer start - and the accuracy with which these things can be measured."

Researchers used the optic probe to measure oxygenated (Ohb) and deoxygenated (Dhb) hemoglobin (Hb) specifically in the colonic lining where small blood vessels circulate. At NorthShore's Evanston Hospital, 222 patients undergoing colonoscopy screening were recruited for the study in 2006-07.

Of these patients, 175 had no adenomas detected, 35 had non-advanced adenomas and 12 had advanced adenomas (polyps larger than one centimeter). The mean age was 56.6 years and 40 percent were female. There were no significant differences in gender. The groups did not significantly differ in tobacco or alcohol history.

The study found that the total Hb concentration was elevated 75.3% above control levels (comparable region from patients with no adenomas) at the adenoma site and persisted in the uninvolved mucosa (microscopically normal) area. Moreover, tissue sites located within 10 and 30 cm away from an adenoma also manifested a highly statistically significant increase in total Hb, OHb and DHb concentration.

"We are not determining whether an abnormality is cancer or not cancer," said Roy. "What we are doing is using optical technology to determine if we can assess risk through looking at field carcinogenesis [cancer formation]. The potential clinical applications included enhance polyp detection during colonoscopy."

While the technology is still in the clinical trial phase," notes Michael Goldberg, M.D., head of gastroenterology at NorthShore University HealthSystem, "it could be available to patients at NorthShore in five years."

Colon cancer is the second-leading cause of cancer death in the United States, killing 55,000 Americans each year. The disease is 90 percent preventable if pre-cancerous polyps are detected early and removed.

"This partnership with Dr. Backman at Northwestern University has the potential of bringing a suite of technologies that is not meant to replace colonoscopy," said Roy, "but rather to more precisely determine risk and thereby help to individualize recommendations on the timing of colonoscopy for colon cancer screening. This improved efficiency and accuracy may aid in cancer prevention efforts."

http://www.northwestern.edu