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Wednesday, January 26, 2011

HERE WE GO AGAIN - Viibryd, the new SSRi

Image: Business Wire

Just when you thought it was safe to go back to your doctor and not be presented with a new option of antidepressant medication.

On Monday 24 January, it was announced that the the U.S. Food and Drug Administration [FDA] had approved vilazodone HCl tablets, to be marketed under the brand name Viibryd, for the treatment of adults with major depressive disorder.

According to a press release, Viibryd is a new molecular entity and the first and only selective serotonin reuptake inhibitor and 5HT.

Stephen M. Stahl, M.D., Ph.D., Professor of Psychiatry, University of California, San Diego, promotes the use of Viibry with the following:

"When treating MDD, our goal is to offer treatment options that meet the individual needs of each patient..." "Viibryd is an important new treatment option with proven efficacy and a demonstrated safety profile."

Wow a psychiatrist promoting a pill, whatever next?

Clinical Data, which owns worldwide rights to vilazodone from Germany’s Merck KGaA, will offer the drug as a new option for treating patients with major depressive disorder.

They confirmed the safety and effectiveness of vilazodone in two eight-week clinical trials. The drug not only acts as a selective serotonin reuptake inhibitor, not unlike the antidepressant paroxetine [Seroxat/Paxil], but it also is supposed to impact the so-called 5HT1A receptor, a target for the anti-anxiety pill buspirone. Though the combination makes the drug unique, the company says the mechanism of the drug isn’t fully understood. [1]

I just love the last line, "...the company says the mechanism of the drug isn’t fully understood."

No shit Sherlock!

Can we, as consumers, accept that the two eight-week clinical trials were carried out with no manipulation of data? Are we expected to offer ourselves up as guinea pigs when the manufacturer is unsure how the drug works? Surely, if they are unsure how it works, they will be unsure how to treat any adverse reactions that  will more than likely arise out of patients taking it?

Here's an idea. It's free advice to doctors.

When a patient comes in feeling depressed, don't reach for the prescription pad because you only have a 5 minute slot with your patient. Tell them to exercise, it's proven to be more effective than the apparent minimal benefits drugs such as Seroxat can offer.

I suspect Clinical Data would have already briefed their reps regarding the promotion of this rebadged brain zapping drug - just like Glaxo did with their little cash cow.

It amazes me how a medicine regulator can grant licence to a drug that can increase suicidal thoughts in those taking it. I suspect the warnings will be minimal, "dizziness, nausea, diarrhea."

No doubt the patient information leaflet will be laden with the phrase "Talk to your doctor if you suffer this or that"

Pharma market it.

Regulators approve it.

Doctors prescribe it.

Patients endure it.

Great. I sincerely hope coroner's keep their eyes on Viibryd.

Rant over.

[1] Clinical Data Stock Surging on FDA Approval of Anti-Depression Drug