Just What We Need: Another Drug With Bad Side Effects
Is there no end to the amount of shit Big Pharma expects us to put up with? Literally?
Shares of Clinical Data Inc. (CLDA) rose after the last late-stage study on its treatment for major depressive disorder achieved the targets for efficacy and tolerance, clearing the way for the treatment’s new drug application to be filed later this year.
The biotechnology company jumped as much 14% Tuesday morning after saying its treatment, vilazodone, was generally well tolerated …
But the study also showed high rates of some side-effects, including diarrhea and nausea.
…
Biologic Investment Research analyst Kevin McNamara didn’t think the study was positive at all. He pointed to the high amount of patients who suffered from diarrhea – 31% – and nausea – 26% – saying the effectiveness of the treatment wouldn’t set it apart from the field.
“The incidence of diarrhea is outrageous, that’s the only groundbreaking thing about this study,” McNamara said. “There just is not another place in the market [for vilazodone].”
…
Clinical Data, which wasn’t immediately available for comment, pointed out in its release that only one patient out of 240 left the study because of diarrhea while three quit because of nausea.
And with two positive Phase III studies now in the books, Clinical Data says it should file its new drug application for vilazodone by the end of the year.
Clinical Data Rises On Study Results For New Antidepressant
liz | 4:14 PM | depression, meds, side effects
Don’t forget, CD thought they could market a genetic marker that would predict efficacy to their drug.
“While our lead biomarker of response to vilazodone did not replicate in this trial, it is one in a series of candidate biomarkers that we will continue to evaluate.”
As they won’t be launching the biomarker with the drug, assuming FDA responds favorably to the NDA (if there is one), I suppose the side effects will have to be the only differentiator. Don’t count out the 5-HT-1A effects just yet. We’ll have to wait and see how the risks and benefits eventually shake out.
There are prescribers who associate side effects with medication response. I have no doubt that should vilazodone be approved some prescribers will tell their patients, Diarrhea is actually a good sign. It means your medication is working.
Reply: