Updated–In a further sign of the chaos surrounding its weight loss drug Contrave, Orexigen has again terminated an FDA-mandated cardiovascular outcomes trial with the drug. Following a year of controversy (see below) Orexigen last month assumed sole control of Contrave (the combination of naltrexone and bupropion) from its former partner, Takeda. The company has now terminated enrollment…
Controversial, Ill-Fated Obesity Drug Trial Published In JAMA
March 8, 2016 by Leave a Comment
The final– but now largely useless– results of the cardiovascular safety trial of the obesity drug Contrave have now been published in JAMA, one year after the trial’s dramatic and scandalous crash and burn. By way of background: Contrave is a combination of naltrexone and bupropion marketed as a weight loss drug by Orexigen and…
Diet Drug Study Crashes And Burns In The Wake Of Leaked Results
May 12, 2015 by Leave a Comment
The ill-fated Light trial, which was supposed to examine the cardiovascular outcomes of the weight loss drug Contrave, a combination of naltrexone and bupropion marketed by Orexigen and Takeda, came to a spectacular halt today. The action was probably inevitable given the extreme controversy generated earlier this year when it became known that Orexigen had widely disseminated results from an early…
Orexigen ‘Crying All The Way To The Bank’ After ‘Egregiously Unethical’ Actions
March 5, 2015 by Leave a Comment
On Tuesday morning the members of the Data Monitoring Committee of Orexigen’s Light study began a planned meeting in a hotel in Chicago. They had no way of knowing that in a few hours their routine duties would be completely interrupted by the news that data from the trial– which they thought was known only to…
Takeda Disagrees With Orexigen Over Data Disclosure
March 5, 2015 by Leave a Comment
(Updated) On Tuesday Orexigen sparked a firestorm by disclosing the interim results of an ongoing clinical trial of its weight loss drug Contrave. Takeda, which markets the drug in the US, has released a statement in which it states that it does not support the release of the interim data. Here is the Takeda statement: “Pursuant to the Collaboration Agreement between…
Orexigen Released Interim Data Without Approval Of Trial Leaders
March 3, 2015 by Leave a Comment
Earlier today Orexigen Therapeutics disclosed positive results from a clinical trial of Contrave, its weight loss pill (a combination of naltrexone and bupropion) that it markets with Takeda. (You can read a good summary of the findings by Adam Feuerstein on TheStreet.) The surprising thing about the Orexigen disclosure, which was contained in a Form…
FDA Approves New Weight Loss Drug From Orexigen And Takeda
September 10, 2014 by Leave a Comment
The FDA announced today that it had approved Contrave, the long-awaited and much-disputed weight loss drug. The drug is a combination of two drugs already approved for other indications: naltrexone hydrochloride, which is used to combat alcohol and opioid dependence, and bupropion, which is used to treat depression and seasonal affective disorder and as an aid to smoking cessation…
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