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May 9th -- May 15

May 11th: FDA Approves Novel Medication for Smoking Cessation

The U.S. Food and Drug Administration (FDA) announced today the approval of Chantix (varenicline tartrate) tablets, to help cigarette smokers stop smoking. The active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health.

Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking.

"Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States and is responsible for a growing list of cancers as well as chronic diseases including those of the lung and heart," said Scott Gottlieb, MD, Deputy Commissioner for Medical and Scientific Affairs. "The agency is committed to helping facilitate the development of products to help people quit smoking and improve their overall quality of life. According to the Centers for Disease Control and Prevention (CDC), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking.

The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized; controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking. These smokers had previously averaged 21 cigarettes a day for approximately 25 years. In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban (bupropion).

Chantix is manufactured and distributed by Pfizer, Inc., New York.

May 12th: Smith & Nephew Receives FDA Approval for BIRMINGHAM HIP(TM) Resurfacing System

Smith & Nephew's Orthopaedic Reconstruction division (LSE: SN)(NYSE: SNN) announced today that the U.S. Food and Drug Administration (FDA) has approved the BIRMINGHAM HIP(TM) Resurfacing system for use in the United States. The BIRMINGHAM HIP Resurfacing system is the only FDA-approved hip resurfacing system available for use in the U.S.

Hip resurfacing is an alternative to total hip replacement for patients suffering from abnormalities of the hip, including osteoarthritis.

The BIRMINGHAM HIP Resurfacing system conserves more of a patient's bone than a traditional hip replacement, enabling younger, more active patients to undergo hip replacement surgery while preserving all future surgery options, including a primary hip replacement. The design of The BIRMINGHAM HIP Resurfacing system also offers patients a better range of natural motion with a reduced risk of dislocation. Smith & Nephew will be training 50 surgeons in the first phase of the U.S. introduction. Training will be provided in the United States and Europe, with the first U.S. surgeries expected to take place this summer.

If you have any comments regarding this update, please email: info@mdiconsultants.com

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