3 weight loss drugs make 2nd bid for approval

The Food and Drug Administration has rejected three prescription diet pills in the last three years, raising questions of whether any weight loss drug can win approval in the U.S. The agency has not approved a new prescription weight loss drug in 13 years. Historically, medications that attempt to burn fat or suppress appetite have been plagued by safety issues.

Don't miss these Health stories 'Stronger': Patient's cancer fight goes viral A 22-year-old leukemia patient with a talent for video has turned the fight against cancer into an online anthem celebrating strength — and recovery. Get your tissues ready.

We go weak in the face of 'cute.' Here's why The reason you can always find room for dessert Oversharing on Facebook as satisfying as sex? Genetics may explain blond Solomon Islanders

Story: Miracle diet pill? Huge craving for a safe drug

Despite the latest rejections, all three drugmakers are resubmitting their products for a second review. Here's a look at the contenders and where they are in the review process:

— Qnexa is a combination of two older drugs: the amphetamine phentermine, which is approved for short-term weight loss, and topiramate, an anti-convulsant drug sold by Johnson & Johnson as Topamax. Phentermine helps suppress appetite, while topiramate is believed to make patients feel more satiated

Many experts view the combination pill as the most promising of the new weight loss drugs, due to studies showing most patients lost nearly 10 percent of their weight — the highest reduction reported with any recent diet pill. But the FDA rejected the drug in October 2010, raising a number of safety concerns, including higher heart rate and birth defects in women who become pregnant.

This week a panel of advisers to the FDA overwhelmingly recommended approval for Qnexa, on the condition Vivus Inc. conduct a follow-up study to make sure the drug doesn't cause heart problems. The FDA is expected to make its second ruling on the drug by April 17.

— Orexigen Therapeutics Inc.'s Contrave is another combination pill aimed at curbing appetite, mixing the antidepressant ingredient in Wellbutrin with the anti-smoking drug bupropion. The company's results have been lackluster, with about 40 percent of patients taking Contrave losing 5 percent of their body weight. Those figures narrowly achieved FDA's minimum requirements for an effective weight loss pill. But Contrave has also been plagued by the heart safety concerns associated with past diet pills. The FDA is requiring the company to conduct a 10,000-patient study of cardiovascular health. That study is slated for completion by 2014.

— Arena Pharmaceutical Inc.'s lorcaserin is the only first-of-a-kind diet drug currently before the FDA. It uses a new type of ingredient to stimulate serotonin receptors in the brain linked with feelings of satiety. But lorcaserin has faced the most severe safety questions from FDA, which rejected the drug in 2010 after raising concerns about cancerous tumors seen in rats who received the drug.

Early this year Arena submitted new information evaluating the link between its drug and cancer. The FDA is scheduled to make a new ruling on the drug by June 27.

Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

View the original article here

Read More »

01.48 | 0 komentar

Discovery Could Lead To Novel Drugs To Prevent Cancer Metastasis

A Loyola University Chicago Stritch School of Medicine study has revealed details of the complex molecular process involving a protein that enables cancer cells to establish tumors in distant parts of the body.

The finding could lead the way to new drugs to prevent breast cancer and other cancers from spreading to new sites.

The study by Adriano Marchese, PhD, and colleagues is published in the March 16 issue of the Journal of Biological Chemistry.

The study involves a molecule on the surface of cells called CXCR4. There is an abnormal abundance of this molecule in 23 types of cancer, including cancers of the breast, lung, pancreas and thyroid.

What usually kills patients is the spread of cancer from the primary site to other sites. A tumor cell breaks away from the primary site and circulates through the body. A molecule called CXCL12 acts like a beacon to CXCR4, signaling the cancer cell to land and start a new tumor.

The goal of the study was to better understand this complex signaling pathway. (A signaling pathway involves a group of molecules that work together in a cell. After the first molecule in the pathway receives a signal, it activates another molecule, and the process is repeated until the last molecule is activated.)

"We understand the final outcome of this signaling pathway," Marchese said. "What we are trying to do now is understand the molecular details."

In the study, Marchese and colleagues used a line of human cancer cells called HeLa. (The cell line is the subject of the best-selling book "The Immortal Life of Henrietta Lacks".)

Using HeLa cancer cells, the researchers identified a molecule that is a critical link in the signaling pathway. Researchers hope to target this molecule, thereby disabling the signaling pathway and preventing the cancer cell from setting up shop in a new site, Marchese said.

The next step will be to develop a drug that blocks the target molecule. Researchers then would test the drug on an animal model. If the drug worked in animals, it later could be tested in a clinical trial of cancer patients, Marchese said.

"We are laying the groundwork for the development of new drugs to stop cancer from spreading," Marchese said.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our breast cancer section for the latest news on this subject. Marchese is an associate professor in the Department of Molecular Pharmacology and Therapeutics of Loyola University Chicago Stritch School of Medicine. His co-authors are Rohit Malik, PhD (first author); Unice J.K. Soh, PhD; and JoAnn Trejo, PhD.
The study was supported by a grant from the National Institutes of Health. Malik was supported by a predoctoral fellowship from the American Heart Association. He graduated in December 2011 and is doing postdoctoral training at the University of Michigan.
Loyola University Health System Please use one of the following formats to cite this article in your essay, paper or report:

MLA

Loyola University Health System. "Discovery Could Lead To Novel Drugs To Prevent Cancer Metastasis." Medical News Today. MediLexicon, Intl., 16 Mar. 2012. Web.
17 Mar. 2012. APA

Please note: If no author information is provided, the source is cited instead.

'Discovery Could Lead To Novel Drugs To Prevent Cancer Metastasis'

Please note that we publish your name, but we do not publish your email address. It is only used to let you know when your message is published. We do not use it for any other purpose. Please see our privacy policy for more information.

If you write about specific medications or operations, please do not name health care professionals by name.

All opinions are moderated before being included (to stop spam)

Contact Our News Editors

For any corrections of factual information, or to contact the editors please use our feedback form.

Please send any medical news or health news press releases to:

Note: Any medical information published on this website is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional. For more information, please read our terms and conditions.

Read More »

14.57 | 0 komentar