Archive for the 'Anti-Obesity Drugs' Category

Vivs set to apply for FDA approval for diet drug

VivusVivus will apply for approval from the FDA by the end of the year to introduce a new diet drug that has impressive potential. The drug, called Qnexa, has more than met FDA requirements in two late stage clinical trials. The drug is made up of two medications already approved by the FDA. One is phentermine, the non-lethal component of the controversial drug Fen-Phen, which was ultimately taken off the market due to reported heart complications. Phentermine, which is of the amphetamine class, is the most prescribed obesity drug in the nation and is typically given to patients who are manifesting weight related illnesses.

FDA assessing weight-loss drug Xenical and Alli

XenicalThe FDA said its regulators are assessing at least 32 reports of liver problems occurred in patients between 1999 and 2008 by taking the weight-loss drug orlistat, sold as a prescription drug Xenical and more recently, as an over-the-counter medication called Alli. Of the 32 reports of liver problems the FDA has in hand, 27 patients were hospitalized and six suffered liver failure. In an “early communication” of a drug safety review, the FDA said it will also review additional data on “suspected cases of liver injury” submitted by drug firms that make and market orlistat in its branded and generic forms.

Study: serotonin could help in development of safer anti-obesity drugs

A study led by a UT Southwestern Medical Center researcher indicated on the brain chemical serotonin, when spurred by diet drugs such as Fen-phen, works to curb appetite. This knowledge could aid in the design of safer anti-obesity drugs nearly a decade after Fen-phen was banned for causing harmful side effects. The study found that serotonin activates some neurons and melanocortin-4 receptors, or MC4Rs, to curb appetite and at the same time blocks other neurons that normally act to increase appetite.

FDA Seeks Recall Of 25 Weight Loss Pills With Potentially Unsafe Ingredients

The Food and Drug Administration (FDA) in the United States is seeking to recall 23 different products marketed as for weight loss because they contain undeclared active pharmaceutical substances that may pose serious health risks to consumers. The products are marketed over the Internet and in retail stores, and in some cases are described as “dietary supplements”. Some of the tainted weight loss products are Fatloss Slimming, 2 Day Diet, 3x Slimming Power, Japan Lingzhi 24 Hours Diet, 3 Day Diet, 7 Day Herbal Slim, 999 Fitness Essence, Extrim Plus and GMP.

Stirling receives patent for its anti-obesity product

Stirling Products has received the first approval for its patent application for “Methods of decreasing fat deposits and body weight in mammals and birds” in New Zealand. The patent relates to the use of the company’s R-salbutamol compound. The product has the potential to reduce body weight. CEO and Managing Director of Stirling Products, Dr Calvin London said that he hoped that a series of approvals in other countries would follow. The company has already conducted studies for the compound on obese male Zucker rats.

GSK receives positive opinion for alli from CHMP

The Committee for Medicinal Products for Human Use (CHMP) has given positive opinion as a non-prescription product to GlaxoSmithKline’s alli (orlistat 60 mg). This takes the product to the stage of proposal for final approval by the European Commission. A marketing authorization will follow that. On the grant of license, alli 60 mg would become the first aid for weight loss to be available without prescription across Europe. It will be indicated for people above the age of 18 with a BMI more than 28 kg/m2.

EMEA recommends temporary suspension of Acomplia from market

The European Medicines Agency (EMEA) has made a recommendation to the European Commission (EC) for suspending Acomplia’s marketing authorization temporarily for the treatment of obese patients. The regulatory body concluded that the risks of Acomplia outweigh its benefits. Side effects such as depression have been a part of the warnings ever since the product was authorized in 2006. Sanofi-aventis is complying with the order, but believes that its product will continue to be an effective treatment.

New model of molecule can prevent obesity

Researchers from Vitagenes (a company that is a  part of the Campus program promoted by the University of Granada) in collaboration with some Australian scientists have discovered a new pattern/model of the molecule called interleukin-6 that may prove to be a boon for the patients suffering from obesity and diabetes. It was injected daily for two weeks. Then, its behavior and effects on the metabolism were analyzed. It was found that the molecule can help in development of drugs that can be beneficial in preventing and treating obesity. The study has been carried out on animals.

Orexigen’s Empatic and Contrave give positive results

Orexigen Therapeutics, Inc. reviewed that Empatic™, the drug in its investigational stage, has proven to reduce the body weight of obese people, who had undergone year-long treatment without any diet and exercise, by 15%. Also, the company has presented some data on Contrave® that shows a 50% reduction in the prevalence of metabolic syndrome, from baseline, in patients of obesity. Both these products, in their development phase, have high potential of solving obesity problems.

Merck & Co. drops taranabant for treating obesity

Leading pharmaceutical developer Merck & Co., Inc. will not be seeking regulatory approval for taranabant, an investigational drug, for the treatment of obesity. The company is going to discontinue its Phase III clinical development program. The available data from Phase III of the trial indicated that both effectiveness and incidence of adverse events were related to dosage, efficacy being greater and adverse events more in the higher doses. After taking this into account, the company determined that the overall profile of taranabant did not support the case for further development of the medication.

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