Obesity pill Qsymia gains FDA approval

Vivus Inc.

(CBS News) After months of anticipation and deliberation, the obesity pill formerly known as Qnexa has been approved by the Food and Drug Administration. The product will be sold under a new name, Qsymia.

The FDA said in an announcement Monday night that Vivus Inc.'s Qsymia is approved for overweight and obese people who have at least one weight-related health problem such as high blood pressure, Type 2 diabetes or high cholesterol. The drug is to be prescribed in combination with a reduced-calorie diet and exercise. Obesity is defined as having a body mass index (BMI) of 30 or more, while overweight people are defined as having a BMI - a ratio of height over weight - of 27 or higher.

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According to government estimates, more than one-third of U.S. adults are obese.

"Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a statement. "Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides another treatment option for chronic weight management."

Vivus had proposed the name Qnexa in the drug's application, but an FDA spokesperson told HealthPop in an email that the drug's name was subject to review to determine if there was potential for confusion with other approved drugs, and the company eventually went with Qsymia to reduce any potential for medication errors.

Qsymia is an extended-release combination of two older drugs, phentermine and topiramate. Phentermine is an amphetamine approved for short-term weight loss and topiramate is prescribed to prevent seizures and migraines, and is supposed to make pill-takers feel more full.

Phentermine was one-half of the popular Wyeth drug fenfluramine, or fen-phen, which was tied to heart valve damage and taken off the market in 1997, resulting in a $13 billion settlement over tens of thousands of lawsuits.

The most common side effects of Qsymia were tingling of the hands and feet, dizziness, insomnia, constipation, a change in taste sensation and dry mouth. Pregnant women should not take Qsymia because it may harm the fetus, the FDA said. The FDA also doesn't recommend the drug for patients with glaucoma and hyperthryoidism, nor patients with recent heart disease or stroke, since the drug may also elevate heart rate.

The drug's safety and efficacy was reviewed in two studies. They showed that after a year of taking the drug, patients lost between 7 and 9 percent of their body weight, and between 62 and 69 percent of study participants lost 5 percent of their body weight, compared with 20 percent of patients taking a placebo.

The FDA said people who took Qsymia and didn't lose at least 3 percent of their body weight by the twelfth week of treatment were not likely to achieve weight loss with continued treatment, and may need a higher dose. If those patients don't lose at least 5 percent of their weight after 12 weeks on the higher dose, they should stop taking the drug.

Qsymia's approval follows the FDA's approval of another obesity pill, Arena Pharmaceuticals' Belviq, in late June. That drug was the first weight-loss pill approved by the FDA in more than a decade, since Xenical (sold over the counter as alli) was approved. Anti-obesity pills face an uphill battle for approval because the drugs often carry side effects.

Back in February, a panel of advisors to the FDA voted 20-2 in favor of approving the drug, but the group stresses that the drugmaker should conduct follow-up studies to look at the pill's effects on the heart. Qsymia was previously rejected by the FDA in 2010, under the name Qnexa, because the drug was tied to elevated heart rate, psychiatric problems and birth defects. Vivus then resubmitted the drug application with additional safety data.

The Associated Press reports that Vivus hopes to bring the drug to market by the fourth quarter of this year, and hasn't decided how much pills will cost.

"Today's decision by the FDA marks the second time that the agency has approved a new obesity treatment drug within the last 30 days," Laurie Traetow, executive director of the American Society of Bariatric Physicians said in a statement. "Obesity medicine specialists are excited about the FDA adding another tool to the obesity treatment toolbox, which for so many years had been virtually barren in the pharmacotherapy area."

[sharonwhatzup]

Hey everyone, here's an inexpensive way to create Qnexa - under $20 per month. I didn't want to wait for approval on Qnexa so created it myself and cheaply. I went to a fly-by-night weight-loss clinic and got a prescription for generic phentermine; it's cheap, about $15 a month (I split a 37.5 MG so it's actually $7.50 monthly). I have several ruptured discs and was taking Gabapentin which unfortunately tends to be a weight positive drug. I asked my Back Doctor to switch me to Topiramate (50mg, AM & PM) which is a good substitute for Gabapentin and is also cheap and covered by Insurance. Neither Doctor knows about the other as the Weight Clinic doesn't utilize technology or accept insurance. I've lost 50 pounds in 5 months and have reached goal weight. Both Doctors think their drug is doing the job solo so it's kind of funny. My Back Doctor is switching over several more of his patients from Gabapentin to Topiramate after seeing my success. Now that Qnexa is approved you may find a doctor willing to prescribe these 2 together. I've saved a ton of money these last 5 months as my monthly food bill has dropped to under $100.

[Traceyami769]

Let me tell you ignorant people who think that people are Fat because they "Eat Too Much" !! I am 5'7. A few years ago I weighed 160 pounds. I was diagnosed with Thyroid disease. My Thyroid was removed. In the first WEEK, I gained 13 pounds. From then on it was constant weight gain. I am Active.. NOT lazy by No MEANS. I work in my yard. I carry heavy things. My house is spotless. I don't Freakin eat McDonalds. Stop with your ignorant comments. I have been on every diet there is. This weight will not come off. If they can approve a PILL that can help me along , then Back OFF !!

[MichaelMonheit]

At risk is the fetus of any woman who could become pregnant while on this drug. Thus it is a category X medication. Be sure to discuss that with your doctor and to make certain you are on appropriate birth control while taking this. Apparently the Topamax component lowers the effectiveness of the birth control, so don't simply assume you are not at risk. Ask your doctor. You can read more about Topamax here: http://www.anapolschwartz.com/practices/topamax/index.asp

[Dede400]

I am appauled by all the name calling on here, have we a society embrace such ugly behavior?? You think everyone who is overweight or obese is a fat lazy pig?? What's your BMI and have you looked in the mirror lately?? There are some people who feel defeated in this battle and if a diet pill gives hope what's wrong with that. How many of you have hypertension, diabetes, high cholesterol?? You probably take medications to help control to live with it right??? Obesity is a disease that effects so many people, maybe diet and exercise isn't enough; maybe they aren't lazy; maybe they watch their diet and maybe they run 4 miles 5 times a week. I see people walking and running trying to make a difference in their lives but they just need a little help along the way, it's a short term treatment. I'm not saying everyone should try it and it shouldn't be a easy fix but maybe it can help while they are learning that they can control their food intake while finding exercise that they can be successful in.

Name calling is like bullying and it really needs to stop. I would never make fun of someone with a serious disease or illness it's plain NOT RIGHT! Opionions are like @ssholes everyone has one but they don't have to be one!

[dawnpilkington]

Dede400 -- With good intentions, I'm offering you some unsolicited advice, which you are of course free to ignore, if you like. I suggest that you pay zero attention to rude posters, and do not respond, regardless of how insensitive or outrageous the comments are. "Trolls" waste time posting inflammatory remarks for the fun of provoking people. Do not rise to the bait, and give them the reaction they want. If the poster is not a troll, you won't change his or her mind anyway. That's my two cents anyway. Have a lovely afternoon, agreeing and disagreeing with people who respect each other. Cheers!

[jtdev1]

These people just want to take a pill with their Double quarter pounder with cheese and a 64oz Coke to wash it all down while they lay on their couch with remote in hand.

There is no need for the gym, weight watchers, jenny craig, pills, or any of that.

Eat NORMAL size portions, drink NOTHING but water, and STOP GOING TO McDonald's and all those ALL YOU CAN EAT buffets


What is wrong with you people????

I'm no health food nut or anything of the sort, I was looking at myself in the mirror and just said, I'm not going to eat like this anymore. I don't want diabetes.

All it took to go from 234lbs to 210 in 1 month was:

Breakfast 1 cup of sliced fruit or 1/2 cup of cottage cheese
Lunch: 1 cup of Barley, tofu, tomato, onion, parsley and cucumber salad.
Dinner: 4 oz steak, or chicken, or pork, or fish NO MORE THAN THAT, with fresh veggies (usually squash or zuccini)


and most important WATER ALL DAY LONG


Doesn't take much to lose it and guess what, I saved over $450 in food and coffee (star bucks) in 1 month.

See you SAVE money when losing weight

Oh yeah, my Triglycerides, Cholesterol and Gluclose/Sugar are now at completely NORMAL levels.


I have energy and now feel like working out to get in real shape.

[SusanMassachusetts]

OMG, YOU HAVE DONE WHAT PHYSICIANS, DIETICIANS, AND OTHER MEDICAL PROFESSIONALS HAVE BEEN STRUGGLING WITH....YOU SINGLEHANDEDLY SOLVED THE OBESITY ISSUE. WOW, AND YOU GAVE AWAY THE INFORMATION HERE FOR FREE. WOW. Thanks.

[jtdev1]

It's called common sense Susan...

eat too much, get fat...

simple, isn't it?

There's always someone/something else to blame for your own actions.

Nothing else in the whole universe causes weight gain but food.

[rightontarget]

Ok, so this is another PRESCRIPTION drug?? (Not over the counter?) Of course, just another way for big Pharm to make money. Not to mention the doctor you might have to see to get the prescription and obtain "treatment". Good Lord!!! I am so SICK of all this crap. Anybody ever get sick and tired of all those Medical Ads on TV urging you to "ask your doctor if blah, blah, blah, is right for you."?? I just want to throw something at the TV every time one comes on. Ever go to the doctor and have the "drug pusher" in the suit with the breif case go in ahead of you to push his samples? It's all about the MONEY folks! Jeez..... Drug pushing pharmaceutical reps should be banned from doctor's offices during office hours AND those advertisements on TV should be made ILLEGAL. Make the doctors read the medical journals to find out about new medicine and don't try to push all the hypocondriacs to rush to their doctor describing their "symptoms" real or imagined just to sell the drug.

[Mikey_Mo]

Goes back to the days of the Medicine man shows, and still works today. Amazing isn't it.
This reminds me of old "See my thumb, Gee your dumb'.
Your glory always comes from within, and not from others, Don't let your habits and addictions control you.
I think most people know what to do, but rather hold out the hand and go with the illusion in stead of what's right. Easy always comes before hard, but the easy way is not always the best way.

[baileycccc]

Another high profit scam for a new generation. After much death, pain and suffering this pill will taken off the market. But the tens of billions will be made, paid out as bribes to doctors and anyone who gives a speech about safe new drugs. The side effects of all these drugs shows the the so called Big Pharma cure is always worst than the disease.

[Choons]

Follow the money on this one. How can the FDA and the US Patent Office allow a company to rebrand a 50 year old drug and a 30 year old drug that are off-patent? Now consumers will have to pay 10 times more than what they were paying to have each drug prescribed individually. This will open the flood gates for pharmaceutical companies to mix and match cheap off-patent drugs costing consumers billions. It's marketing, not innovation. 10 years from now we'll be hearing the same horror stories that phen-fen caused, but by then the company will have pocketed billions and the FDA officals that rubber stamped this will have high-paying jobs at the pharma companies they helped perpetrate this scam.

[selfdoer]

are you kidding? all so the drug companies can make a profit while probably making someone even sicker. this is disgusting. they need to couple the drug with a diet and exercise program. really? how about that alone being the prescription?

[badboymoviestar]

Take 4000mg of Cinnamon, and 100mg of green tea extract 15 minutes before each meal.

Cut any sugar you can out of your diet.
No breads. Only whole grains.
At least 2 servings of vegetables at every meal.
Eat 4 smaller snacks instead of 3 larger meals.
Drink at least 4 liters of water daily.

I'm in the process of doing this, and I've lost 12.5 lbs in 13 days.

I'm 6 feet 3 inches tall, and currently weigh 210lbs, so it doesn't just work on someone who's morbidly obese...


Try it, and see the results yourself!

[badboymoviestar]

Sorry, that should read 1000mg of Green Tea extract.

[SusanMassachusetts]

You know-it-alls are a hoot!! Condense every person into one category and judge. Tooot Tooooot

You come across like the fools you are.