FDA approves highly anticipated weight-loss pill

WASHINGTON (AP) - The Food and Drug Administration on Tuesday approved a new weight loss drug from Vivus Inc. that many doctors consider the most effective therapy in a new generation of anti-obesity pills designed to help patients safely shed pounds.
The agency cleared the pill Qsymia for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
Patients taking Qsymia for a year lost 6.7 percent of their body weight in one study and 8.9 percent in another study, the FDA said. That was more than two other weight loss pill recently reviewed by the FDA.
Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough, and its development underscores the slow pace of research for obesity treatments.
The drug is actually a combination of two older drugs that have long been known to help with weight loss: phentermine and topirimate.
Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satiated after eating.
Researchers say the innovation of Qsymia lies in targeting multiple brain signals that drive people to overeat.
"We now know there are multiple pathways that determine how much energy we take in every day," said Dr. Tim Garvey of the University of Alabama at Birmingham. "If you intervene on one pathway it's hard to make much of a difference, you really need to attack multiple mechanisms to get a pronounced effect."
Garvey helped conduct several pivotal trials of the drug.
Qsymia is the second weight loss drug approved by the FDA in less than a month, following Arena Pharmaceutical's pill Belviq in late June. Previously the agency had not approved a new drug for long-term weight loss since 1999.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments. But a long line of prescription diet pills have been associated with dangerous side effects, particularly heart problems.
In 1997, the popular diet drug combination fen-phen was linked to heart valve damage. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by the FDA. Fenfluramine was eventually withdrawn from the market.
Other safety failures for diet pills have continued to pile up in recent years. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke.
The FDA's successive approval of Qsymia and Belviq suggests a new willingness to make weight loss medications available, even in the face of lingering safety issues.
The FDA initially rejected Vivus' drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.
The agency also said patients with recent or unstable heart disease or stroke aren't good candidates for the drug because its effect on heart rates in those patients is not known. Vivus has to do studies of the heart effects of Qsymia, the FDA said.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus Inc. plans a slow rollout.
The pill will launch in the last quarter of the year with a relatively small sales force of 150 representatives. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors.
"We're going to have to grow our sales organization in order to support the primary care market," said Vivus president Peter Tam, in an interview with the Associated Press.
Vivus had originally planned to market the drug under the brand name Qnexa. However, FDA regulators ordered the company to change the name to avoid potential confusion with similar sounding drugs.
Rival Arena Pharmaceuticals Inc. of San Diego plans to start selling Belviq in early 2013. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.
The agency cleared the pill Qsymia for adults who are obese or overweight and have at least one weight-related condition such as high blood pressure, diabetes or high cholesterol.
Patients taking Qsymia for a year lost 6.7 percent of their body weight in one study and 8.9 percent in another study, the FDA said. That was more than two other weight loss pill recently reviewed by the FDA.
Despite its impressive performance in clinical trials, Qsymia is not exactly a scientific breakthrough, and its development underscores the slow pace of research for obesity treatments.
The drug is actually a combination of two older drugs that have long been known to help with weight loss: phentermine and topirimate.
Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss. Topiramate is an anticonvulsant, sold by Johnson & Johnson as Topamax, that makes people feel more satiated after eating.
Researchers say the innovation of Qsymia lies in targeting multiple brain signals that drive people to overeat.
"We now know there are multiple pathways that determine how much energy we take in every day," said Dr. Tim Garvey of the University of Alabama at Birmingham. "If you intervene on one pathway it's hard to make much of a difference, you really need to attack multiple mechanisms to get a pronounced effect."
Garvey helped conduct several pivotal trials of the drug.
Qsymia is the second weight loss drug approved by the FDA in less than a month, following Arena Pharmaceutical's pill Belviq in late June. Previously the agency had not approved a new drug for long-term weight loss since 1999.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments. But a long line of prescription diet pills have been associated with dangerous side effects, particularly heart problems.
In 1997, the popular diet drug combination fen-phen was linked to heart valve damage. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by the FDA. Fenfluramine was eventually withdrawn from the market.
Other safety failures for diet pills have continued to pile up in recent years. In 2010, Abbott Laboratories withdrew its drug Meridia after a study showed it increased heart attack and stroke.
The FDA's successive approval of Qsymia and Belviq suggests a new willingness to make weight loss medications available, even in the face of lingering safety issues.
The FDA initially rejected Vivus' drug in 2010 over concerns that it can cause birth defects if taken by pregnant women. The agency laid out a risk-management plan Tuesday specifically designed to minimize the chance of the women becoming pregnant while using the drug. It recommends that women of childbearing age test negative for pregnancy before starting the drug and take a monthly pregnancy test while taking it.
The agency also said patients with recent or unstable heart disease or stroke aren't good candidates for the drug because its effect on heart rates in those patients is not known. Vivus has to do studies of the heart effects of Qsymia, the FDA said.
Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus Inc. plans a slow rollout.
The pill will launch in the last quarter of the year with a relatively small sales force of 150 representatives. Company executives say their initial marketing efforts will focus on obesity specialists, not general doctors.
"We're going to have to grow our sales organization in order to support the primary care market," said Vivus president Peter Tam, in an interview with the Associated Press.
Vivus had originally planned to market the drug under the brand name Qnexa. However, FDA regulators ordered the company to change the name to avoid potential confusion with similar sounding drugs.
Rival Arena Pharmaceuticals Inc. of San Diego plans to start selling Belviq in early 2013. A third California drugmaker, Orexigen Therapeutics Inc., is still running clinical trials of its product, Contrave, and is working toward an FDA approval date in 2014.
Put down the twinky and back away from the pills and no one gets hurt!!
This is great news! There are so many 12 sandwich eatin slobs that intentionally eat their way right into "not being able to work for a living and signing up for DSHS" and then letting it turn into Diabetes while applying for medicaid, ssi and every other program out there that was intended as a safety net instead of simply getting up off their duffs and doing something like earning their own way. Its really maddening when they have all these tax payer funded operations for fat removal, fat bands, arthritic damaged joints from too much weight and no activity, it just doesn't end til we pay to bury them and then start supporting their fat kids. Maybe we can give them all a presciption of this and send them packing and save a few bucks. It reminds me of that convict that ate his way out of a hanging he deserved.
Taking an anticonvulsant to lose weight? Â Oh dear. Â That's crazy. Â How about eating less and moving more? Â It has worked since the beginning of mankind. Â
How about making it illegal to advertise food and beer after 7:00 p.m.....naw that won't work either, I still have to walk past the fridge and food pantry on my way to the bathroom.......
Â
Taking responsibility for ones actions is hard - please pass the pills....
When people give up on hope that a pill is going to do it for them, maybe we will see progress with obesity. Â A friend of mine took phen phen and lost 20 lbs in 2 months, but the doctor told him first to stop drinking juice and pop, and replace it with water, and to stop waiting until he's full to stop eating, but instead to stop eating when he's simply not hungry anymore. Â Add to that he needed to exercise, and I had to ask the question "what the he** is the pill for then"?
Â
Without question some people gain and keep wait easier than others, but lifestyle changes by far are the best remedy, not a pill.Â
I say no thanks to weight loss meds. I started my "new way of living" about 2 months ago and have lost 10lbs so far. Might not be much to some, but 10lbs loss, is better than staying where I was or even gaining (I have quite a bit to get rid of). I've been a lot more active and eat less junk. I don't cut anything out, but I don't eat as much as I would have months ago. I notice that my pants are a little baggy now and it feels great! I'm looking forward to losing weight the right way: activity, eating better and NO help from a pill :)
"Phentermine is a stimulant that suppresses the appetite, and has long been used for short-term weight loss"
Â
Sounds like legalized speed...
"Analysts estimate the new pill could garner more than $1 billion in sales by 2016, though Mountain View, Calif.-based Vivus Inc. plans a slow rollout."...I wonder if this has anything to do with FDA approving this with lingering safety concerns?
this is the third day in a row I've seen some new drug pushed on here. Just because the FDA approves it, doesn't make it safe and people need to research it on their own first.Â
 @nomad Exactly!  Do you ever hear the rapid-fire side effects of some of the drugs on TV commercials?  "Can cause cancer of various kinds, heart ailments, tuberculosis, brain tumors, SUDDEN DEATH."  And that's just for one antidepressant! Â
Everything can be fixed with a pill, brought to you by your neighborhood multi-billion-dollar pharmaceutical company.
@blaster Yup, we live in a pharmacuetical age. This is because big PHARMA lobbyists put forth the most $. I think this is bad news because I believe that this restricts many medical breakthroughs simply because of money. I would like to see it made illegal for the private sector to lobby
I can picture them sweating profusely, fogging up their plastic respirator with every labored breath of excitement.
How about eat less and exercise more for a weight loss program?
Now if I can just get up from behind this computer and move my fat butt to the pharmacy...
These pills like many others give me concern as the result of so many others that are "FDA Approved" and later been found to cause serious and deadly problems. These pills may not, but many have with causing cancers, heart problems, kidney problems and so on. The speed with which these pills (not the diet pills) have been approved seems to be more money driven rather than health driven as they should be. Some times I wonder just what FDA stands for.
Exercise not included.
 @None Much easier to just pop a pill and hope for the best