FDA Rejects Orexigen's New Diet Drug Contrave Over Heart Concerns The future of the obesity drug business took a hit on Tuesday when the last of a slate of three proposed new diet drugs, Orexigen's (OREX) Contrave, was rejected by the Food and Drug Administration due to concerns over heart problems, despite having been the only one of the three recommended for approval by the FDA's advisory panel.

Shares in the California-based company, which closed up 9.25% Monday at $9.09 in anticipation of an approval of the first diet pill in decades, tanked by some 72% trading at around $2.60 by midmorning.

The FDA is concerned enough about the cardiovascular safety profile of Contrave when used long-term in a population of overweight and obese people that it's requiring Orexigen to conduct yet another study to address the issue. The FDA wants a "randomized, double-blind, placebo-controlled trial of sufficient size and duration." That will be neither easy nor cheap.

"We are surprised and extremely disappointed with the Agency's request in light of the extensive discussion and resulting vote on this topic at the December 7 Advisory Committee meeting," said Michael Narachi, president and CEO of Orexigen. While Orexigen and its partner Takeda appeared ready to continue -- at least for now -- such an undertaking may not be feasible.

Three Similar Diet Drugs, Three Different Health Concerns


The diet drug business has grown tougher over the years, especially in the wake of the phen-fen fiasco of the 1990s, when that combination treatment was linked to heart-valve damage and lung problems. In October, Abbott's (ABT) Meridia was pulled from the market because of safety concerns.

The recent obesity drug saga began a few years back, when three companies began a race to be the first on the market with similar new obesity drugs: Vivus (VVUS) with Qnexa, Arena (ARNA) with lorecaserin, and Orexigen with Contrave. Qnexa and lorecaserin were ahead in the FDA's process, and after both failed either to receive the backing of the advisory panel or to get approved, investors put their hopes in Contrave, especially after the advisory panel voted 13-7 to recommend approval, saying that a study of potential cardiovascular risks could wait after approval.

Now, instead of reaping projected sales of hundreds of millions of dollars, all three companies will have to spend more money before resubmitting their drugs to FDA scrutiny. But while Orexigen is facing another long and expensive drug trial, as of now, Vivus and Arena only have to submit more data. Vivus was asked to do data analysis on potential birth defects of Qnexa, and is expected to resubmit the drug some time in 2011, while Arena has to resubmit data on potential cancer risks from lorecaserin, which it will probably do by the end of the year.

Though the FDA is putting consumer safety first, some are concerned that the agency may be going too far, especially considering the rise in obesity in the U.S. In December, Jennifer Lovejoy, president of The Obesity Society, said, "We are deeply concerned about the effect that the FDA's recent decisions will have for on-going and future research into desperately needed new obesity treatments. ... we hope that the agency will assure a balanced process, taking into account the urgent medical need."


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teetse

Why not ban high fructose corn syrup, and transfat the real culprets of obesity. I think most of us would like real sugar and natural fat anyway, We already take too many drugs that have horrible side affects.

February 03 2011 at 11:39 AM Report abuse rate up rate down Reply
Sultry

Ever wonder why the FDA always seem to reject diet pills? Yet they put their stamp of approval on drugs that have side effects like, Liver dysfunction, Sever headaches, blue vision, browning of the whites of your eyes that is permanent, blood clots, hypertension, diabetes, stroke, heart attacks, skin rash, change in mood, violent dreams, hair falling out, thoughts of suicide, an erection that could last for 4 hours. Bet that hurts. You can't take, or even handle the drug if pregnant, or it may abort the pregnancy, but definitely will retard and deform the baby, incapacitate you so bad you can't drive a car, or operate heavy machinery, and the all time "Sudden death." I was just wondering if anyone besides me was trying to figure just WTF good is FDA approval? If the approved drugs side effects are acceptable, I guess they are protecting us from having orange and blue flames shoot out our ass from taking a diet pill that didn't get approved.

February 02 2011 at 6:29 PM Report abuse +2 rate up rate down Reply
alfredschrader

Heart issues are not funny, but I'm just wondering about The Obesity Society.
So if you work there, do you have to weigh four something ? Are all of the doors extra wide ? Special big restroom equipment & stalls ? Do you have to wait in line at the snack machine ? Do you risk death if you buy-out the Heath bars ? Is all of the furniture structural steel ? Do the elevators have special placards that say maximum two persons at a time ?

February 02 2011 at 7:07 AM Report abuse -3 rate up rate down Reply
fedretdot

I am sick and tired of the FDA and their overcautious approach to diet drugs. The government pushed people to quit smoking only for us to gain lots of weight but won't approve drugs that could help us lose it. I can't believe they are all dangerous. When is the FDA going to allow people to use their own judgment about whether they are willing to accept the risks of drugs?

February 02 2011 at 5:54 AM Report abuse rate up rate down Reply
jokesl3

Members of the FDA have vested interests in the stock market, most likely indirecty to make tracing difficult. They drive the price of these stocks up and short them before delivering the death blow. They need to be investigated by the SEC.

February 02 2011 at 5:19 AM Report abuse +1 rate up rate down Reply
Charmelle2

This is the same FDA that has Victoza on the market...the drug that many have been taking since it was approved early last year- It's the same FDA that allowed Victoza ON the market..APPROVED the drug...despite insisting that the makers set up a SPECIAL TUMOR REGISTRY (aside from regular tumor registry)..in order to FOLLOW patients who sadly get placed ON this "special" Victoza Tumor Registry... THE LIST IS ALREADY GROWING ! This is b/c Victoza gave such a HIGH LEVEL OF TUMORS to Lab Animals in TESTS done BEFORE THE DRUG WAS APPROVED- The special tumor registry was set up with the idea that Victoza patients should be MONITORED over the NEXT 15 yrs..esp being watchful for reported cases of the ONCE RARE "MEDULLA" THYROID CANCER that VICTOZA TREATED LAB ANIMALS DEVELOPED ! With so many drugs being approved by FDA, despite KNOWN/REPORTED KILLER EFFECTS in lab animals (in tests BEFORE the drugs were approved...such as Prilosec, Nexium, also Nutrasweet..which CAUSED TUMORS IN LAB IN ANIMALS...) WHY IS FDA ALLOWED TO GET AWAY with APPROVING (KNOWN) KILLER substances for human consumption?

February 01 2011 at 9:28 PM Report abuse +4 rate up rate down Reply
emtdea

Funny how 3 small companies that have developed weight loss drugs that work have been denied at the last minute by the FDA. Kinda makes me think the FDA is in the back pockets of the big pharmaceutical companies that need people to be overweight to have high blood pressure, diabetes, sleep apnea, etc. The medication the Vivus had denied again is nothing more than a combination of 2 medications that have been on the market for years (in lower doses) and have their safety already known. Doctors around the country are already prescribing the combination of medications in Vivus' Qnexa as 2 separate pills and have huge success including reduction in cholesterol levels, blood pressure and decreased insulin use. Some patients have lost over 100 lbs in a 1 year. Just another sign that yet another government agency is corrupt.

February 01 2011 at 8:57 PM Report abuse +7 rate up rate down Reply
travelergtoo

Finally, it took a real man(Obama) to put people in charge of the FDA that would actually look after the interests of citizens instead of taking kickbacks and ******* up to Big Pharma.

February 01 2011 at 8:31 PM Report abuse -4 rate up rate down Reply
akapnis22272

It isn't worth taking a weight loss drug Http://treatingcholesterol.info if it damages your heart.

February 01 2011 at 8:19 PM Report abuse rate up rate down Reply
1 reply to akapnis22272's comment
pprecious10

No offense, but being overweight damages the heart... as a matter of fact, what doesn't? except eating cardboard...and give that study some time..

February 01 2011 at 10:41 PM Report abuse +3 rate up rate down Reply
jerald3739

The FDA provides the guidence that companies developing new then follow. The FDA uses an Advisory Board of experts to review clinical test data In the case of Orexigen the company further discussed what was needed to satisfy the FDA. Clinical trials were conducted and approved. The orexigen drug Contrave was recommended for approval by the Advisory Board and then THE FDA PULLS OUT THE RUG AND SAYS EXPANDED TESTING WAS NEEDED. Why does the FDA need an Advisory Board if they choose to ignore their recommendations and then change the parameters of studies that exceed what they previously established. This is prududicial conduct. Over 300 million dollars of capitalization was lost. Three companies were basically destroyed by the incompetency of the FDA. And now hiding behind safety 50% of the population are without any prescription medicine to use to reduce their weight. They are exposed to dying from obesity and diabetes. The FDA needs an ionvestigation.

February 01 2011 at 5:40 PM Report abuse +4 rate up rate down Reply
1 reply to jerald3739's comment
anderson3820

So true. Almost weekly the FDA is doing things that are more asinine than before. "Black box" warnings are just a blank check for the plaintiff attorney, and worry doctors and patients pointlessly. Oh, black box warning - can't use this one anymore. No, we still use them, just with more anxiety. They regularly cause drug shortages through restricting manufacturing of things like narcotics. Recently they would not allow companies to move chemical materials across international borders - which screwed up manufacturing supply chains. Why? just to throw their power around. We need to get rid of them. That's right. Just get rid of them and save the money.

February 01 2011 at 9:53 PM Report abuse +2 rate up rate down Reply