Main Category: Alcohol / Addiction / Illegal Drugs
Also Included In: Erectile Dysfunction / Premature Ejaculation
Article Date: 27 May 2011 – 10:00 PDT

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A 27-year-old man from Uxbridge in northwest London was yesterday (26 May 2011) fined £10,000 at Southwark Crown Court for selling unlicensed medicines for erectile dysfunction.

Saranjit Bhambra pleaded guilty on 26 April 2011 to one offence of selling medicinal products that contain ingredients found in medicines that can only be supplied with a prescription or by a qualified pharmacist.

The Medicines and Healthcare products Regulatory Agency (MHRA) launched the investigation known as Operation Rome following a test purchase of a pack of four Tadil tablets from Bhambra’s website.

The test purchase led to a search at a car mechanic’s garage, where officers found evidence connected to an illegal online pharmacy supplying medicinal products including tadalafil and sildenafil.
Both tadalafil and sildenafil are potent active ingredients and should only be taken when directed by a healthcare professional, who has access to a patient’s individual records, and supplied through a registered pharmacy.

MHRA Head of Enforcement, Mick Deats, said: “While websites such as these may look professional, what we see behind the scenes tells a very different story.

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Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Regulatory Affairs / Drug Approvals;  Men’s health
Article Date: 16 May 2011 – 1:00 PDT

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The U.S. Food and Drug Administration is warning consumers about a potentially harmful product represented as “ExtenZe,” a dietary supplement for male sexual enhancement. The counterfeit product looks similar to the actual product, but contains hidden ingredients that can cause serious harm to consumers. The counterfeit product has the following lot numbers on the packages:

- LOT 1110075

- LOT F050899

FDA laboratory analysis confirmed that the counterfeit product contains tadalafil, or a combination of tadalafil and sildenafil –active ingredients in FDA-approved prescription medicines for erectile dysfunction. These ingredients are not listed on the product label.

These ingredients may interact with other medicines, like the nitrates found in some prescription medicines such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

The counterfeit product is illegal and unsafe. The FDA is advising consumers not to purchase any products labeled as “ExtenZe” with lot numbers 1110075 and F050899. Consumers who have an ExtenZe product should check the lot numbers on the package to make sure they do not have a counterfeit product. Consumers who think they might have the counterfeit product should:

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Main Category: Erectile Dysfunction / Premature Ejaculation
Also Included In: Urology / Nephrology;  Sleep / Sleep Disorders / Insomnia
Article Date: 16 May 2011 – 2:00 PDT

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Two studies that link the quality of sleep to the occurrence of erectile dysfunction (ED) and other urologic conditions were presented to reporters during a special press conference at the Walter E. Washington Convention Center in Washington, DC, Sunday, May 14, at 2:00 p.m. during the 2011 Annual Meeting of the American Urological Association (AUA). The session will be moderated by Kevin McVary, MD.

Erectile Dysfunction Is Independently Associated With Sleep Apnea In A Large Population Of Middle-Aged Men (#1325): In the largest study to date demonstrating the relationship between obstructive sleep apnea (OSA) and erectile dysfunction, researchers from Mount Sinai Medical Center in New York evaluated 870 consecutively enrolled men in the ongoing Law Enforcement Cardiac Screening program (LECS), a subset of the World Trade Center Medical Monitoring and Treatment Program. Patients who scored positive on the Berlin Questionnaire (a widely used survey for OSA) were defined to be at high risk for OSA. ED was assessed by use of the International Index of Erectile Function -5 (IIEF-5), and was defined as IIEF of less than 22. A multivariate, binary logistic regression was performed to adjust for age, history of cardiovascular disease, systolic blood pressure, diabetes, smoking and body mass index (BMI).

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Main Category: Clinical Trials / Drug Trials
Also Included In: Erectile Dysfunction / Premature Ejaculation
Article Date: 31 Mar 2011 – 1:00 PDT

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Global Health Ventures Inc. (OTCBB:GHLV), a specialty pharmaceutical company, is pleased to announce the interim results of the clinical trials conducted in Europe under the EMEA guideline protocols for its lead therapeutic drug, X-Excite.

Data analysis from a small number of patients showed the drug to meet the three Pharmacokinetics (PK) end points. Blood analysis of the patients receiving X-Excite showed the drug to appear in the blood 173% faster than Pfizer Viagra®. By 10 minutes about one quarter of peak concentration (T max Value) apeared in the blood. Further, X-Excite (blood concentration, C max) never exceeded the C max of Viagra®, a good sign for drug’s acceptability as biosimilar. Additionally the T max was lo! wer (about 15%), and better (wider) spread, a possible sign of less side effects. Finally it appeared that X-Excite remains in the blood slightly longer than Viagra®, possibly due to some gastric absorption, thus may provide a longer performance. Although these are the results of a small number of patients, it indicates a highly positive trend and it is meeting our expectations.

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Main Category: Erectile Dysfunction / Premature Ejaculation
Article Date: 21 Mar 2011 – 17:00 PDT

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Today marks the launch of the first ED treatment available as an orodispersible tablet. In contrast to other drugs of the same class, the new formulation has been designed specifically to be discreet and convenient, has a minty flavour and dissolves on the tongue within seconds2. It is packaged in a new, thin black pocket-sized box which is unlike traditional pharmaceutical packaging and also incorporates numerous anti-counterfeiting measures. Currently, an estimated 2.3 million UK men suffer from ED, yet only 1 in 10 receive treatment3 and according to market research commissioned by Bayer, 4 in 10 men regard presently available therapies as inconvenient4.

“Bayer is committed to men’s health and is continuously striving to develop new and innovative treatment options for people living with erectile dysfunction, which is becoming more prevalent in the UK but is still undertreated,” said Marc van Unen, Business Unit Head General Medicine. “Levitra orodispersible was developed to help remove the known barriers associated with erectile dysfunction medication by providing men with a more convenient and discreet treatment option which may also help to lessen the embarrassment surrounding the condition. It is hoped that ultimately, the advantages of the new product and its discreet packaging, which includes 120 anti-counterfeiting measures, will reduce the growing numbers of patients purchasing counterfeit pills online and lead to improved patient satisfaction and treatment outcomes in ED overall.”

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