Good news on a new antidepressant (no more sexual side effects)
As is well knows many of us with depression must take antidepressants that have a very severe inpact on our sexual libido. Currently there is a new class of antidepressant in the testing phazes right now that does the same thing as SSRI's but without the sexual side effects. The drug is called Vilazodone and is classified as a SSSRI (Super Selective Serotonin Reuptake Inhibitor) The drug eliminates the sexual dysfuction because it is far more selective in it's action than present drugs.
I have some doubts as to just how effective it will be for more severe cases of depression, but it is showing promise.
Below is the drug data:
Clinical Data Inc. has found an antidepressant drug candidate that has met the main goal in a second late-stage study. The new drug candidate is called vilazodone.
Clinical Data this week announced positive results from the second of two Phase 3 clinical trials of its product candidate vilazodone. The new drug will be used to treat major depression if approved by the FDA. Phase 3 clinical trials are the final phase of research required by the FDA before it can consider a drug for approval.
Vilazodone has a new dual approach as a selective serotonin reuptake inhibitor and a partial agonist of the 5-1a receptor.
In the study, vilazodone offered statistically significant results on the primary endpoint and secondary efficacy endpoints, said Clinical Data in its news release.
Moreover, the effects of vilazodone on sexual function were comparable to that of a placebo.
The sexual side effects of the new drug are important because many antidepressants cause or worsen sexual dysfunction.
However, the study failed to replicate a proprietary lead biomarker. This is a test that predicts response to treatment which had been identified in the first late-stage trial as potentially associated with response to vilazodone.
The company also noted that the new drug was “well tolerated” by patients, with only one patient out of the 240 subjects in the study discontinuing the drug because of diarrhea. Three additional patients stopped taking the drug because of nausea.
Doctors and patients alike are looking for treatments for major depressive disorder, noted Carol Reed, executive vice president and chief medical officer of Clinical Data. The positive results from this study, along with the results of the prior Phase 3 and long-term safety studies, will provide a basis for the company’s New Drug Application (NDA) filing with the U.S. Food and Drug Administration by the end of 2009.
The main purpose of an anti depressant is to relieve symptoms of depression is it not? This report says little or nothing of promise in that regard and focuses on lessened sexual side effects.
Frankly I have no interest in a med except for the mental benefits. Sexual issues I consider secondary or even further down the list when compared to my need for mental relief.
I know many think this is important and of course it is to younger people as life revolves around sex and sexual prowess/performance. But please don't forget that depression itself is a huge negative influence on the libido in itself. We tend to push loved ones away when depressed so what point is there to improved sexual performance in that scenario?
I'd suggest that any med that focuses on the sexual side effects as the major issue is not a med I want anything to do with. Better to just stop meds altogether mate.
This comment in your quoted text is very telling I'm afraid :
"However, the study failed to replicate a proprietary lead biomarker. "
Actually you would be very shocked to know that the issue of sexual side effects are VERY important to approx 80% of sufferers that must take antidepressants.
Time and time again this issue is posted with massive regularity on just this site alone.
On the other hand I am like you in the respect that my depression is so cronic and severe that I could care less if a drug turned my hair blue and made it fall out, as long as it actually worked for me.
I will admit that I am a little bothererd by the sexual side effects I get from my meds, but for me they are not a deal breaker.
Regarding your question about this drugs effectivness and the data to support that fact.... " Clinical Data this week announced positive results from the second of two Phase 3 clinical trials of its product candidate vilazodone."
This is simply stating that Vilazodone is showing positive results in controlld studies thus far. Obviously there is more studies to be completed to prove it's efficacy and to get FDA approval, but as I said prior, it looks optimistic.
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