I hate to brag, but…

I hate to brag, but…

February 28, 2007
Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

It wouldn't surprise me if they said yea to antidepressant use and nay to vasomotor use because of lack of evidence in improved symptoms.

April 19, 2007
Wyeth looking for Pristiq's FDA approval in 2008

I'll follow Pristiq as the information continues to trickle out but don't expect to hear much about it until next year when Wyeth becomes the proud papa of a brand new (and approved) product.

This is one of the few times I can actually say I was right. (Teenage-like "squee!" goes here.)

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Pristiq's under-the-radar clinical trials

News stories on Wyeth’s Pristiq, Effexor’s “knockoff”, have focused on the drug’s uses that are pending FDA-approval: vasomotor symptoms accompanying menopause (see hot flashes) and depression. (“Knockoff” term courtesy of CLPsych.) The major media has failed to pick up on Wyeth’s Phase III clinical trials to use Pristiq for fibromyalgia and neuropathic pain (injured tissue or damaged nerve fibers) in diabetics. A search for Pristiq on Wyeth’s Web site yields no results. Desvenlafaxine yields two very meager results.

In related matters, bifeprunox is pending FDA-approval for the use of schizophrenia and is still in Phase III for use of bipolar disorder. They are also in Phase III of testing Lybrex (levonorgestrel) for use for Premenstrual Dysmorphic Disorder in addition to the drug functioning as an oral contraceptive. (I’ll be honest; I had NO clue that diagnosis existed.) In any event, I’ve been misdiagnosed because according to the symptoms, I qualify. I think I also qualify for OOPS – Overdiagnosed and Overmedicated Patient Syndrome.

I’d like expound on Wyeth’s Learn and Confirm phase that’s supposed to replace Phase I and II of clinical trials. It sounds like a speedier way to just get drugs to Phase III of clin. trials, but it’s late and I’m working on something else, so I’ll save that for another day.

Also something to tackle in the future: All these interesting clinical trial results for Effexor XR involving depression and GAD. We’ll see…

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Mood: 6.5

Pristiq's FDA Chances: Depression – Yea; Menopause – Nay

As more info on Pristiq continues to roll out, I'll do my best to track them quite closely.

While Wyeth scrambles to resolve issues in its Puerto Rico plant to meet FDA standards, Ms. Kathleen Kerr of Newsday recently reported on Pristiq's potential to be approved for use in depression and hot flashes resulting from menopause. I was so excited to see some decent reporting on a mental health issue in a paper other than the NYT. It was also nice to see that it didn't end with "Shares of Wyeth fell 38 cents Friday to close at $51.50 on the New York Stock Exchange."

"If Pristiq wins Food and Drug Administration approval, it will be the first antidepressant and only non-hormonal remedy marketed specifically for hot flashes. But Pristiq isn't without problems – it poses rare suicide risks in young people."

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