The drugmaker made the decision after spending months reviewing trials showing the taranabant obesity pill caused psychiatric side effects. You may recall that a late-stage trial showed the drug didn’t yield the hoped-for weight loss of 5 percent at the 2 mg dose the drugmaker hoped to sell.
The 4 mg dose achieved the desired weight loss but came with a significant catch - the dosage more than doubled instances of psychiatric side effects than a placebo. And even the 2 mg dose proved problematic: nearly twice as many patients taking it removed themselves from the trial, compared with the placebo, citing suicidal thoughts and neurological effects. Remember that the Merck pill is similar to Acomplia, the Sanofi-Aventis fat fighter that failed to win FDA approval over psychiatric side effects, specifically depression and suicide.
And so, John Amatruda, Merck senior vp and head of obesity and diabetes research, issues this statement: "Available Phase III data showed that both efficacy and adverse events were dose related, with greater efficacy and more adverse events in the higher doses. Therefore, after careful consideration, we determined that the overall profile of taranabant does not support further development for obesity."
pic thx to alan cleaver on flickr
2 Comments
I am so sorry to hear that the study will not merit taranabant for sale. I was on the program before the dosage was reduced. I removed myself for outbursts, I was not suicidal. I am taking lexapro now and gained most of my weight back. I feel a study should be made with a small doseage of an anti-depressant, because having gained the weight back I am surly depressed and I was looking forward to the FDA approval.
I hope in the future you look this medication over again because it works.
Thank You, Pat
Sometimes these things happen, not a lot you can do about it. The medication did work, but its best for everyones health and weight that they did what they did. Thanks for the article pharmalot. Appreciate the time you put into it.