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FDA Says No to Pfizer’s Pain Medication Lyrica for Generalized Anxiety Disorder

Posted Dec 25 2009 6:16pm 2 Comments

Treatments for anxiety and depression certainly seem to be headliners quite frequently in the news today.  In just writing this blog it seems to be that I tend to see more about those 2 types of drugs than most others.  The FDA said no on this account for Pfizer as the information submitted was not sufficient.   Lyrica is a pain relieving drug as it is approved for use today.  image I certainly hope more psych drug applications and medications themselves are not the answers to living through the current economy.  It does make one wonder when you see headlines like this:

Night club drug could ease depression – Ketamine

Back on topic here with anxiety though Pfizer goes back to the drawing board.  Recently I read about some of the fattest cash rich public companies out there and Pfizer was at the top of the list, and the article went on to say they had pockets of around 52 billion cash sitting around.  BD 

Pfizer Inc.’s earlier-rejected, resubmitted application for the use of its Lyrica capsules CV as a mono-therapy for generalized anxiety disorder has met with yet another rejection by the US Food and Drug Administration (FDA).

The FDA, which had issued a Lyrica stand-alone treatment related “non-approvable” letter to Pfizer in August 2004, has concluded again that the data contained in the drugmaker’s New Drug Application for Lyrica is not sufficient enough to receive approval.

Pfizer’s resubmitted Lyrica for anxiety application rejected by FDA | TopNews United States

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is an anticonvulsant, analgesic and anxiolytic-acting gamma-aminobutyric acid analogue. It binds to voltage-dependent calcium channels, so that the channels closed, thus reducing the calcium influx at the nerve endings and the release of excitatory neurotransmitters such as glutamate, noradrenaline and substance P is decreased.
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