Qnexa Proponents Ask U.S. Experts To Back The Obesity Drug

* Qnexa helped patients lose weight

* One ingredient tied to birth defects

* Uncertain effect on the heart

* FDA advisory panel to vote on drug Wednesday afternoon

* Vivus shares halted pending vote

By Anna Yukhananov

SILVER SPRING, Md., Feb 22 (Reuters) - Proponents of a new obesity medication from Vivus Inc told U.S. reviewers on Wednesday that the drug's health benefits exceed heart and birth defect risks.

A panel of outside experts to the Food and Drug Administration will vote later on Wednesday on whether to recommend approval for what would be the first new prescribed drug for obesity in 13 years.

The FDA first rejected Vivus' Qnexa in 2010 because of safety problems, along with two other obesity pills that are also seeking a second round of consideration.

The FDA usually follows panel recommendations, although it is not required to. It will make a final decision by April 17.

Qnexa, which combines the appetite suppressant phentermine and anti-seizure drug topiramate, helped patients lose at least 10 percent of their weight after a year of treatment, the company said .

Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States, with about a third of the population obese and more than half overweight.

"Back in medical school, I was taught that when the risk of not treating the condition exceeds the risk of treating it, we should treat," said Dr. Arya Sharma, a chair in obesity research at the University of Alberta in Canada and paid consultant to Vivus.

"We have an obligation to change how we measure obesity. Qnexa addresses an urgent and substantial unmet medical need for our patients," he told panelists.

The FDA has set a high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them, and has not approved a new obesity drug since 1999.

Also, many diet pills have been linked to serious heart-related risks.

But patient groups say the FDA is holding obesity drugs to a higher standard than other treatments because of views that it is a choice, not a disease. They are urging the FDA to approve new obesity drugs that would give patients another option between lifestyle changes and surgery.

Shares of Vivus were halted on Nasdaq on Wednesday pending the outcome of the FDA panel meeting. They closed at $10.55 on Tuesday, well above the stock's low around $4.70 after the pill was first rejected.


SAFETY RISKS

FDA staff presenting on Wednesday said the key issues with Qnexa were about safety, not efficacy.

Staff reviewers have said patients taking the drug had more safety problems, including memory loss and higher heart rates, than those on a placebo, and some of these problems could get worse over time.

They have also noted that exposure to one of the ingredients in Qnexa has been linked to a higher rate of birth defects.

A Vivus study showed topiramate caused a higher rate of oral clefts in infants of women taking the drug during pregnancy, and the company said it would limit Qnexa to women who are not pregnant.

The FDA has said the rate of potential birth defects is about two to five times higher with topiramate than with placebo.

Vivus officials said obesity, and its common symptom diabetes, come with their own risks to pregnancy, such as stillbirth, premature birth and other complications.

The FDA and the company generally agreed on a program to mitigate the drug's risks to pregnant women, including limiting the drug to certified pharmacies and training doctors who would prescribe it.

Panelists will discuss whether they think the program is stringent enough to protect patients from the risk of birth defects.

In clinical trials, Qnexa also increased patients' heartbeats, leading to fears it may have negative effects on the heart. However, Vivus said the drug also reduced blood pressure, and a link between heartbeat and heart health was not conclusive. (Reporting by Anna Yukhananov; Editing by Tim Dobbyn)

Comments

[William Anderson LMHC]

08:55 AM on 02/23/2012

As an obesity treatment expert, let me emphasize that weight loss cannot be achieved without behavior change, establishing habits that result in eating fewer calories than used. If a medication can help a person to do this, without adverse risk, I am all for it.

I suffered the misery of obesity for 25 years before I established a successful solution through Behavioral Medicine and lost 140 pounds. I have maintained my ideal body weight for over 25 years and have been helping others since.

As a Licensed Mental Health Counselor with a lifetime of treating mental disorders, let me make it clear that an array of thought and behavior disorders are affected by disorder in brain chemistry, and the effective treatment is medication. Good examples are depression and OCD, a relative of compulsive overeating. Treatment with medication alters the brain chemistry to relieve depression and OCD symptoms. We know that medications can reduce appetite and eating compulsions. Are drugs the solution to obesity? No. Behavior change is. But in some cases, drugs help, and in some cases, it seems behavior change is not possible without drugs.

Let's not forget that the solution to obesity is in behavior change. Sometimes, drugs can help, but drugs can only be a part of the answer. Most of the time, drugs play no part. Always, the answer is in Behavioral Medicine.

William Anderson, LMHC
Author of 'The Anderson Method - Secrets of Permanent Weight Loss'
www.TheAndersonMethod.com

[ann borg]

08:35 PM on 02/22/2012

This is dangerous and someone needs to let the public know about the ill-affects of Topamax (Topiramate). It literally made me have 10 of the 12 symptoms of Alzheimer's - no joke, not being overly dramatic, and in no way diminishing what those poor people who have it go through. I'd rather have my mind whole than use it to lose weight, which did happen. However, the means did not justify the ends. I couldn't remember how to do my job that I had been doing for over a decade, I couldn't remember anything from one moment to the next, I would forget where I was driving to and would go the wrong way, I can't remember my kids' lives for the time I was on it, I was so apathetic that when and if I got out of bed I was on the couch the rest of the time, and I began having suicidal thoughts. Those are just a few of the things Topamax did to me. Check out the stories of others who took/take it on crazymeds.us if you need more convincing. It eventually didn't stop my seizures, so I stopped taking it. One of the best things I ever did.

[REGHIR]

04:31 PM on 02/22/2012

FDA advisory panel just approved QNEXA is a 20 to 2 vote now onto FDA

[Sameh Ali]

01:01 AM on 02/23/2012

Studies show that it raises the heart rate and might cause heart palpitations and that is why it has been disapproved earlier!
The pharma lobby is getting powerfull by day..
http://flyingtrout.net/qnexa-and-the-arabian-travel-market-models/