FDA Approval for the New Antidepressant – Pristiq

Even with the numerous antidepressants out there, any new drug that gets approved by FDA generates a huge amount of interest and expectation.

Pristiq from Wyeth is the newest antidepressant approved by the Food and Drug Administration (FDA) on Friday. It is the successor to the top-selling Effexor, the extended-release depression drug from Wyeth. Pristiq is expected to hit the market in a few months.

Pristiq is a once-daily serotonin-norepinephrine reuptake inhibitor to treat adult patients suffering from major depressive disorder (MDD.)

Major depressive disorder (MDD) is a mental disorder affecting millions of people worldwide. We all experience grief and mood changes related to circumstances but depression that restricts our ability to function and dissipates interest in life certainly cannot be just a case of “blues.” It is a serious medical condition and is not something people usually “get over.” This illness is associated with imbalance in the brain.

It may be hard to digest but the fact remains that depression is a very common illness, although people don’t talk about it or accept it and usually push it under the carpet. It is common enough to be called, “the common cold” of psychiatric disorders.

To get a clear picture of the extent of this illness, here are the facts and figures provided by the World Health Organization:

1. Nearly 5-10% of people in a community suffer from depression at a given time.
2. About 8-20% of people carry the potential risk of developing depression during their lifetime.
3. The average age for the onset of MDD is anywhere from 20 to 40 years.
4. Percentage of women with depression is higher than men.

This illness needs to be diagnosed early and treated with proper drugs and there are several of them available in the market.

Effexor XR was developed by Wyeth and was the first drug to be approved by the FDA for MDD and currently is one of the most widely prescribed antidepressants in the world. Speculation is ripe that Effexor XR loses its patent protection in the year 2010 and it hopes that Pristiq will replace it. The reason behind the creation of a hopefully suitable replacement for Effexor XR is because it makes about $3.8 billion in sales each year.

Wyeth reveals that Pristiq has proved to be more effective when taken in lower doses of 50mg, than higher doses of 100mg. This is believed to be the very first time that a drug company has publicly displayed their data to the world, showing that less of their drug is better than more of it.

When a new drug is released, comparisons are inevitable. According to Wyeth, Pristiq is similar in composition to Effexor, but devoid of the concerns that were present with Effexor XR.

It is too soon to get deep into discussion about the benefits and side effects, when compared to Effexor XR or any other drug out there in the market. Industry experts feel that Pristiq will have to prove itself as better than other antidepressants, unless Wyeth releases the drug at a lower price than Effexor. There certainly is a lot of expectation from this drug and it remains to be seen what it does.

Join the discussion

  • If you’re depressed, you may need to live with it and not rely on pills to feel better because anti-depressants may not really work.

  • Alex,

    Being depressed is not the same as having Major Depressive Disorder. Although having depressed mood is a symptom.

    Anti-depressants do work. MDD and bi-polar depression run in my family so I have experience beyond my own.

    MDD is an extremely serious condition and approximately 15% of those suffering with it commit suicide. There is no reason that “you may need to live with it”. Please seek treatment.

    Too bad there isn’t a treatment for stupidity and ignorance. Alex would surely benefit.

  • Alex – many problems can occur if people try to live with it. Worse case scenarios are that people with MDD will harm themselves or others. In other conditions I have had the unfortunate experience of having friends with aches and pains try and tough it out and not seek medical attention. In those cases those aches and pains turned out to be treatable cancers that were left to long. They are no longer with us. Same dif. Alex.