Qnexa - weight loss drug

Discussion in 'Vivus Pharmaceuticals' started by Anonymous, Jan 10, 2009 at 9:42 AM.

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  1. Anonymous

    Anonymous Guest

    Orexigen to Post Obesity Data in Race With Vivus, Arena
    Adam Feuerstein
    01/06/09 - 04:20 PM EST
    Orexigen Therapeutics(OREX Quote - Cramer on OREX - Stock Picks) is expected to release the first phase III data on its experimental weight-loss drug Contrave ahead of a key investor presentation Monday.

    The new Contrave weight-loss data come from one of four phase III studies being conducted by Orexigen this year. The company is one of three relatively small drugmakers -- Vivus(VVUS Quote - Cramer on VVUS - Stock Picks) and Arena Pharmaceuticals(ARNA Quote - Cramer on ARNA - Stock Picks) are the other two -- in a race to develop the next generation of obesity drugs.

    In December, Vivus announced results from a phase III study of its weight loss drug Qnexa. Arena is expected to have data from its obesity drug later this year.

    Orexigen has not given an exact date for the release of the Contrave phase III data other than to say an announcement will be made before the company gives an presentation to investors Monday morning at the J.P. Morgan Healthcare Conference in San Francisco.

    Contrave consists of two currently approved drugs combined together to suppress appetite and fight food cravings. One of the drugs in Contrave is naltrexone, currently used to fight opioid and alcohol addiction; the other drug is the antidepressant bupropion.

    In a previously reported phase II study of Contrave, patients taking the drug lost between 6% and 7% of their body weight over 48 weeks, adjusted for placebo.

    In the phase III study to be reported later this week, approximately 800 patients were treated for one year with either Contrave or a placebo. Both groups of patients were also asked to go on strict diets and offered intensive behavioral modification therapy to boost their weight loss.

    The added "lifestyle change" component makes predicting the outcome of the Contrave study more difficult.

    In a typical obesity drug trial, patients treated with a placebo would be expected to lose about 1% to 2% of their body weight. However, in the Contrave study, the placebo patients will probably lose more weight because of the diet and counseling they're also receiving.

    J.P. Morgan analyst Cory Kasimov predicts that a 6% to 7% weight loss reported by Contrave patients, adjusted for placebo, is likely enough to satisfy investor expectations.

    In other words, if placebo patients manage to lose 5% of their body weight in the study, patients treated with Contrave need to lose between 11% and 12% of their body weight for the drug to be deemed successful. Kasimov has an overweight rating on Orexigen and a year-end 2009 price target of $18 a share. Orexigen is a banking client of J.P. Morgan.

    The safety and tolerability of experimental obesity drugs are both very important, especially in light of safety problems that have forced older weight-loss drugs to be pulled from the market.

    The U.S. Food and Drug Administration is paying careful attention to the potential for any new weight-loss drug to induce mood changes or behavioral and/or psychiatric side effects.

    For Contrave, in particular, earlier formulations of the drug caused many patients to report significant nausea. A change to a sustained release form of naltrexone, being used in the current phase III Contrave study, is expected to reduce the rate of reported nausea.

    Results from three other, ongoing phase III studies of Contrave are expected in the middle of the year.

    Orexigen is also developing a second weight-loss drug, Empatic, which consists of bupropion and the anti-seizure medicine zonisamide.

    Orexigen shares closed up 40 cents, or 6.8%, to $6.29 Tuesday.
     

  2. Anonymous

    Anonymous Guest

    Congratulations on wanting to help people lose weight. In the meantime... check out a new company with an all-natural, patent pending, food sprinkle called "CHEAT". Sprinkle it on food and reduce 25% of your calories. It really works and available to the public tomorrow, Jan 29th. Take a look for yourself... http://www.CHEATyourDiet.com
     
  3. Anonymous

    Anonymous Guest

    Can you sprinkle that shit on beer?
     
  4. Anonymous

    Anonymous Guest

    VIVUS Announces Date of FDA Advisory Committee Review of Qnexa for the Treatment of Obesity

    Endocrinologic and Metabolic Drugs Advisory Committee Meeting Scheduled for February 22, 2012

    MOUNTAIN VIEW, Calif., Dec. 23, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS) today announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on October 17, 2011 seeking approval to market Qnexa in the United States. The FDA accepted the NDA for review on November 3, 2011. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.
     
  5. Anonymous

    Anonymous Guest

    $20 per share in after hours trading.
     
  6. Anonymous

    Anonymous Guest

    Dude, ex pharma guy here. I would love to go peddle this to all those fat receptionists and put some in there food!

    How many sales people work here? Just curious
     
  7. Anonymous

    Anonymous Guest

    What is anyone's input on if they think the obesity drug will be approved on July 17th.

    It looks like a great drug. The efficacy looks good. Although there are some safety concerns
    it doesn't seem enough to hold back the drug in not getting approved.

    Also, is there a sales force to promote the drug?

    I'm currently unemployed and looking for a job.

    Thank you for any thoughts, comments, and or opinions.
     
  8. Anonymous

    Anonymous Guest

    Interviews are already set, how could you not have applied I think PDI called everyone I know about this contract?
     
  9. Anonymous

    Anonymous Guest

    when will PDI inform candidates of Final Interview times?
     
  10. Anonymous

    Anonymous Guest

    actually this recruiting effort has been one of the most selective processes and thorough
    evaluations of candidates-requirements for qualifying for the interviews and moving forward
     
  11. Anonymous

    Anonymous Guest

    So I take it that the drug is probably going to be approved.
     
  12. Anonymous

    Anonymous Guest

    I didn't know about the drug until recently and I do apply to pdi postings but i guess
    i wasn't selected for an interview.

    Dam! we'll good luck to you all in selling in what i think is going to be a great drug.

    do u think it will be approved on the 17th of july?
     
  13. Anonymous

    Anonymous Guest

    has anyone heard the same thing as this posting that is in
    another vivus thread?


    Yesterday, 04:58 PM
    Anonymous

    Posts: n/a
    Re: Qsymia No Product

    This drug will not be approved. Vivus heard earlier today. To all those who stood beside them. Thank you.

    i hope not