Posts Tagged ‘Contrave’

Anti-Obesity Drugs Advance

December 20th, 2013

Novo Nordisk has filed a New Drug Application with the Food and Drug Admistration for a 3 mg dose of liraglutide, a once-daily human GLP-1 analogue, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight  in adults with obesity, or who are overweight with comorbidities. The emerging evidence indicates that GLP-1 reduce hunger-driven feeding, the hedonic value of food and food-motivation. Further, there is some evidence that the effect of GLP-1 on reward behavior is not limited to food-related reward but also extends to cocaine, amphetamine and alcohol reward. See review. In a clinical trial, at 2 years patients on liraglutide lost 3 kg more weight than those on orlistat. The two year prevalence of  prediabetes was reduced by 52% and the metabolic syndrome by 59% with improvements in blood pressure an lipids.

Also, Orexigen Therapeutics Inc. has resubmitted it New Drug Application to the FDA for its anti-obesity compound, Contrave. In November, Orexigen submitted results from a study requested by the FDA to rule out major adverse cardiovascular events.  The company has expressed confidence that Contrave with will be approved by the FDA next year in the US and in Europe as well.

 

Orexigen and FDA Agree on New Study

February 6th, 2012

Orexigen Therapeutics Inc. has announced that it has reached agreement with the Food and Drug Administration on a new protocol to test for adverse cardiac events for it obesity-fighting compound, Contrave. Orexigen Therapeutics, Inc. – Press Release

A Path Forward for Contrave?

September 21st, 2011

Orexigen Therapeutics has announced that, following a meeting with the FDA, it has reached an agreement on a cardiovascular outcomes trial. If the trial meets agreed upon endpoints, it will be approved by the FDA. While the FDA will still convene an Advisory Committee meeting in 2012 to discuss cardiovascular outcomes for obesity drugs, that discussion will not affect the agreement with Orexigen.  See their press release. Orexigen Therapeutics, Inc. – Press Release This is exciting news, indicating a possible path forward for their product, Contrave.

Contrave bites the dust

June 3rd, 2011

After negotiating with the FDA over whether a cardiovascular trial had to be done pre or post approval, the FDA held out and Orexigen folded.  Orexigen Therapeutics, Inc. – Press Release Evidently, the FDA wanted a trial of between 60.00 and 100,000 patients. Orexigen propsed a trial of between 12,000 and 15,000 patients. The FDA said no, of course. Orexigen Says FDA’s Requests for Contrave Trial Aren’t ‘Necessary or Feasible’ – Health Blog – WSJ

 As indicated elsewhere (scroll down to September 10,2010), the FDA is in a bind. An obesity drug of moderate efficacy, they feel, is not worth any risk. While a drug with significant weight loss (read Qnexa) they fear will be used by so many people (since obesity is an epidemic, after all) that unforeseen adverse events will arise and they will have to take the drug off the market. Then there is the head of the FDA Drug Evaluation Center who wants to make drugs for weight loss into drugs for cholesterol or hypertension.( See What’s Up with the FDA, Part 2)  Make no mistake, the FDA bureaucracy is more afraid of the embarrassment of withdrawing a drug from the market (see the Avandia discussions) than they are of the mortality and morbidity of obesity.

Interestingly, (ominiously??) , the Orexigen release indicates that the FDA will hold an advisory committee early next year on the cardiovascular aspects of obesity therapeutics. This could be the final nail in the coffin of obesity therapeutics.

Pharma Companies Hang in There

May 15th, 2011

Drug companies battered by the FDA earlier this year are not taking no for an answer. Vivus Inc. is in discussion regarding Qnexa to make it available for men and women who are not of childbearing age.  UPDATE 1-Vivus to submit Qnexa application as limited indication, shares up | Reuters  Arena Pharmaceuticals  is looking at a three month study of breast tumors in rats rather than the 12 month study the FDA wanted.   Arena pushing shorter study of rejected diet pill – SignOnSanDiego.com  while Orexigen is examining cardiac function effects of its drug, Contrave, see Orexigen submits diet-pill test plan to FDA – SignOnSanDiego.com

What’s Up with the FDA? – Part 2

May 15th, 2011

I’m sorry are we bothering you with all this obesity stuff?

As you know the FDA was quite busy this last 12 months or so with reviews of Meridia, Qnexa, lorcaserin and Contrave. Meridia is off the market now while the other three are holding on for dear life. It came as no shock to those closely watching the meetings of the Endocrinologic and Metabolic  Advisory Committee that the FDA really doesn’t much like dealing with obesity. Now, we know why. They are not curing hypertension or diabetes. That’s what the head of the FDA drug center, Janet Woodcock, right,  wanted to see. And that’s what she told Reuters in this interview. FDA official sees drug approvals rising | Reuters

So, think about this for a moment, the top FDA drug official casually tosses off the FDA’s own guidances for developers of obesity drugs regarding efficacy and says, well, she wishes they were other drugs entirely. Imagine if she said, well, we have turned down this drug for breast cancer because it didn’t  improve Alzheimer’s disease or  cure multiple sclerosis. Or if she said of a drug rejected  for HIV/AIDs, that she would like to have seen it cure Parkinson’s disease?  Would she stay in office the rest of the day? Would it not be a huge embarrassment to the FDA, the HHS, the medical community, the Administration? Why is it  ok for obesity? Is is any less intellectually vapid?  Is that why one of people who works for her, running the Endocrinologic and Metabolic Advisory Committee process this year, apologized, APOLOGIZED! to the panel for “putting them through this unpleasantness.” The “unpleasantness” Dr. Coleman was referring to was the Committee’s job, namely, reviewing new drug applications for obesity. Dr. Coleman, went on to add, “I guess you should be thankful you don’t have to do this everyday for your living.” (See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM232443.pdf at page  304) Is this a cry for an intervention, a plea for a new job? Or a sign of an institution so biased against all this obesity that no obesity drug will ever be approved no way, no how? Can these people give obesity drugs a fair hearing? The FDA has rules on Conflicts of Interest. How about rules on Lack of Interest?

FDA’s Decision on Contrave

February 3rd, 2011

February 3, 2011

The FDA’s decision on Contrave has received widespread and largely negative press coverage. Here is the New York Times article by Andrew Pollack which includes my take on the issue. F.D.A. Fails to Approve Diet Drug

FDA Spikes Another Obesity Drug

February 1st, 2011

Orexigen Therapeutics Inc. indicated today that the Food and Drug Administration (FDA) has, in effect, decided not to approve the company’s obesity drug, Contrave ® in spite of a federal advisory panel vote of 13-7 in favor of approval in December of 2010. The FDA is requiring the company to complete a lengthy and expensive pre-approval of cardiovascular risks. Previously, the FDA had rejected two other new compounds: one developed by Vivus Inc. (Qnexa®) and the other, lorcaserin, by Arena Pharmaceutical Inc. (Lorquess ®) The FDA also pressured Abbott Laboratories to take orlistat (Meridia®) off the market.

According to Morgan Downey, editor and publisher of the Downey Obesity Report, “The FDA has decided that the most significant threat to public health will not be treated by any drug. In the current environment, tap water could not be approved. This is the first time in the FDA’s history that it has decided to abandon a major public health challenge. No doubt the FDA will continue to regularly approve drugs which cause weight gain and to half-heartedly police dangerous and unproven dietary supplements claiming to achieve weight loss. These actions have driven both large pharmaceutical companies and small biotech companies out of obesity research and development. At this time, only Vivus Inc.’s Qnexa has a hope of meeting FDA’s approval.” The FDA has asked Vivus Inc. to explore databases to rule out birth malformations due to one of its elements.

                                                            ###