More good news

More good news in Obesity Medicine, please take a look. This is a piece of an article from the Obesity Society newsletter directed to the medical community.
Enjoy!

September brings two major milestones for obesity treatment  Letter from the Executive Director Dear Colleagues, Last week was an exciting week for obesity treatment. The FDA acted twice in favor of  expanding needed obesity treatment options — action that will bring new tools for  clinicians treating the disease, and for millions of people affected. 1) On Wednesday (9/10), FDA approved the new drug treatment, Contrave™, for  the long-term medical treatment of obesity in adults. Contrave (combination of  naltrexone sustained release [SR] and bupropion [SR]) is a drug developed by  Orexigen Therapeutics, Inc. and will be marketed by Takeda Pharmaceutical  Company Limited. It is expected to be available on pharmacy shelves this fall, and —  like all obesity medications — is considered an adjunct to diet and exercise. 2) The very next day (Thursday, 9/11) an expert advisory committee appointed  by the FDA voted by an overwhelming margin of 14-1 to recommend approval  of a Novo Nordisk drug, liraglutide 3mg (proposed brand name Saxenda®), for  obesity treatment. The Committee agreed liraglutide 3mg has a favorable benefit/risk  profile for the treatment of obesity. The next step for this medication will be a final ruling  by the FDA, which is due in October. Currently, liraglutide is approved and marketed under  the brand name Victoza® at doses of 0.6, 1.2, and 1.8mg for the treatment of type 2 diabetes.

News from a Lifestyle friend

Hi everyone! Sorry I have not posted anything in such a long time.
This time I have no miracle news to share with you but just a link to one of our dear friend's new blog. Please visit it, it will give you a new look on disease and their circumstances. The interest in sharing this link is not only to advertise our friend's blog but for you to see that weight is not just an aesthetic problem, actually, that is the last and least of our concern about it. It is linked to disease that does not even cross our minds ( well, it does cross mine, that is why I'm your physician) or the mind of the one carrying the weight. The blog talks about a patient's perspective on a recent serious diagnosis and his own experience going through it. It is worth the time, I promise.  I have to tell you also that I am including this link and related information with the permission of the author.  You will also find the link on the list of links at the bottom of the blog page.

bthumor.wordpress.com

Dr P

Food additives

This posting is not meant to scare you or put you on the look out for every possible hidden additive in food, but just for you to pay attention to the list of foods that contain them, then link them to certain side effects. The list of foods this additives are on are mostly breads, ice cream, diet sodas, potato chips and some obscure side dish foods that come in a box. This explains in part, why, when you exclude this type of food items of your nutrition plan, you start feeling a lot better.
Please check the link:
http://eatthis.womenshealthmag.com/slideshow/15-scariest-food-additives#sharetagsfocus

New drugs not yet available

Lorcaserin

Lorcaserin/BelviQ

In June 2012, the US Food and Drug Administration approved our internally discovered and developed drug, BELVIQ® (lorcaserin HCI).
We are also seeking regulatory approval for lorcaserin in the European Union, and intend to seek regulatory approval for lorcaserin in additional territories. Regulatory agencies outside the US will independently review lorcaserin.
Our wholly owned subsidiary, Arena Pharmaceuticals GmbH has granted Eisai Inc. exclusive rights to commercialize lorcaserin in most of North and South America, including the United States, Canada, Mexico and Brazil, subject to applicable regulatory approval.
We have patents or patent applications that cover lorcaserin in the United States, Europe, Canada, Mexico, Brazil and many other jurisdictions that, if issued, in most cases would be capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity we might obtain.

BELVIQ will not be available for sale in the United States until after the Drug Enforcement Administration of the US Department of Justice determines BELVIQ’s final scheduling designation.

Qnexa/Qsymia

FDA Approves Qnexa

July 18th, 2012 by MorganDowney Leave a reply »

Vivus Inc. announced today that the Food and Drug Administration (FDA) has approved its anti-obesity drug, Qnexa^, which has been renamed Qsymia^tm .  Qsymia^tm is a combination drug, composed of phentermine and topiramate, both of which have been approved by the FDA for years. As we have previously reported, Osymia^tm has the most impressive weight loss of any obesity drug. The FDA has recommended patients discontinue the drug if they lose less than 3% of body weight on the mid-dose formulation or less than 5% on the high dose after 12 weeks. They also recommended monitoring of heart rate for people on the drug and that women of child-bearing age have a negative pregnancy test every month while using the drug. A Risk Evaluation and Mitigation System (REMS) plan includes distribution through certified pharmacies, a medication guide and a timetable for assessments.

The Risk Evaluation and Management Strategy information, Medication Guide, Safety Information and Health Provider Training Program can be accessed at: http://www.qsymiarems.com/

New drugs for obesity treatment

Finally, after rejecting many times new options to treat obesity from the pharmaceutical industry, the FDA has given its blessing to two new drugs, Lorcaserin and Qnexa. Both drugs aide in appetite control. They both have been able to produce at least a loss of 5% of total weight compared to placebo and no more than that.  So, the message to patients is still the same. No matter how many drugs we can use, if you can not control the calories, there will be no miracle. these drugs as the ones currently in use will not operate the change, you will. But still it is a great thing to be able to count on more options to help you with the process. Lorcaserin is a new drug, Qnexa is a combination of two drugs, Topiramate and Phentermine, that we already use of label, is just that now we have the blessing of the FDA and hopefully your insurance will cover it if indicated.
Please read below the information on Lorcaserine, I will also add something on Qnexa.

FDA Approves Lorcaserin

June 27th, 2012 by MorganDowney Leave a reply »

The Food and Drug Administration announced today that it has approvedlorcaserin (to be marketed as Belviq)for the treatment of adult obesity. The drug was developed by Arena Parmaceuticals and went through two advisory committee panels. The final panel voted to recommend approval by a vote of 18-4. This is the first drug for treating obesity approved by obesity since sibutramine was approved in 1997.

Lorcaserin is a novel drug that targets a specific serotonin receptor. It was a different serotonin receptor which was implicated in heart valve problems associated with use of the dexfenfluramine component of Fen-Phen. The FDA briefing document for the Advisory Committee meeting on May 10, 2012 states  that it “is unlikely at the proposed clinical dose” will activate the receptor implicated in the heart valve problem.

The receptor lorcaserin does impact is concentrated in the central nervous system (CNS) and regulates feeding behavior.

In the latest published study of the drug, the BLOOM-DM study led by Patrick O’Neil, 604 patients who were obese or overweight with type 2 diabetes were randomized into a treatment group and a placebo group. Both groups received lifestyle counseling. The group on drug lost 4.5-5% of their initial body weight while the placebo group lost 1.5%. PubMed: Clinical Trial of Lorcaserin in Type 2 diabetes Weight loss in patients with type 2 diabetes is notoriously difficult to achieve.  A 5% weight loss is considered to provide clinically meaningful changes. Weight reduction was evident at 2 weeks which means that patients who don’t see weight loss are likely to discontinue use early on in treatment. Glycemic control improved more in the lorcaserin group. There were not significant changes between the group on drug and on placebo in regard to cholesterol, triglycerides and blood pressure. The lack of statistical significance may be due to the use by a majority of patients being on blood pressure or lipid medications at the start of the trial.

Arena Pharmaceuticals, developer of lorcaserin, has agreed to conduct a number of post-approval trials, including one to assess cardiovascular effects.

New drug Qnexa

The fact that the FDA advisory committee had voted in favor of this drug does not necessarily mean it will be approved by the FDA but at least it is a good first step. Qnexa is a combination of two drugs that have been in the market for many years and are commonly used, Phentermine and Topamax. I am including a copy of the public communication from OCC.

Obesity Care Continuum (OCC) Applauds FDA Advisory Committee Resounding Approval of QNEXA

For Immediate release
February 23, 2012               
                                                                                                              
For More Information:
James Zervios
Director of Communications
Obesity Action Coalition                                   
(800) 717-3117 
http://us.mc1610.mail.yahoo.com/mc/compose?to=jzervios@obesityaction.org
or
Francesca Dea
The Obesity Society
Executive Director                                 
(202) 210-8942
http://us.mc1610.mail.yahoo.com/mc/compose?to=fdea@obesity.org

Washington, DC – Members of the Obesity Care Continuum (OCC) are pleased with the FDA’s Advisory Committee near unanimous vote to approve QNEXA, a new drug to treat those affected by obesity and obesity-related co-morbidities, such as Type 2 diabetes, hypertension and more.

“The robust discussion by the panel surrounding both the risks and benefits of new obesity drugs is both refreshing and powerful,” said Obesity Action Coalition (OAC) President and CEO Joe Nadglowski. “Clearly, our message about treating obesity seriously is beginning to resonate with the FDA,” added Ted Kyle, RPh, MBA, Chair of The Obesity Society’s Advocacy Committee.

The 20 to 2 vote was surprising given the risk-oriented composition of the FDA chosen advisory committee, which included a number of experts in cardiovascular disease and neonatology – FDA suggested risk areas associated with QNEXA. Despite the strong endorsement of the advisory committee that the FDA approve QNEXA, member groups of the OCC remain cautiously optimistic until the agency renders its final decision this April. In 2011, the FDA failed to approve Contrave despite the obesity drug being approved by an advisory committee the previous year.

“Currently there is a vast gap in treatment options.  We have diet and exercise, and we have surgery, with nothing in between. Until we have more treatment options, such as obesity drugs, millions of Americans in this gap will continue to suffer from the devastating effects of untreated obesity,” said Dr. Patrick O’Neil, President of The Obesity Society.” “This a hopeful day for those affected by obesity. We hope that FDA shares this view as well,” added O’Neil.

About the Obesity Care Continuum (OCC):
With a combined membership of more than 125,000 healthcare professionals and patient advocates, the Obesity Care Continuum (OCC) is dedicated to promoting access to, and coverage of, the continuum of care surrounding the treatment of overweight and obesity. The OCC also challenges weight bias and stigma oriented policies – whenever and wherever they occur. The OCC is a coalition of the Obesity Action Coalition (OAC), the Obesity Society (TOS), the Academy of Nutrition and Dietetics (AND) and the American Society for Metabolic and Bariatric Surgery (ASMBS).