Posted by Dan Perkins on January 1, 2005, at 14:38:36
In reply to WOW. Any idea why???, posted by lia mason on January 1, 2005, at 13:54:48
Here's another exerpt, though I couldn't find anything that explains exactly why it is considered a controlled substance. It's a little bit scary that they are having such a hard time with Lyrica when they had no problem getting drugs like Vioxx and Celebrex on the market. Makes me wonder what the real problems with Lyrica are . . ................................................
Lyrica has been delayed for several years. Early on, FDA asked Pfizer to perform more studies on the drug's safety, after some mice taking the drug in early tests developed tumors. Subsequent studies in rats and monkeys found no tumor problems. Three years ago, Pfizer said it would postpone applying for FDA approval until it completed clinical studies to support multiple uses of Lyrica. The company finally submitted its application in 2003 for three indications: epilepsy, anxiety and pain.
In September, the FDA rejected Lyrica as a treatment for generalized anxiety disorder. Pfizer said it hasn't given up on that use. If approved to treat anxiety, Lyrica would be an alternative to antidepressants and older anxiety drugs called benzodiazapenes, such as Valium.
Pfizer said clinical studies of Lyrica involved more than 9,000 patients, making the project one of the largest for a drug active in the central nervous system. The most common side effects were dizziness, sleepiness, swelling from retained fluid, or edema, dry mouth and weight gain.
European regulators approved Lyrica in July to treat nerve pain and as an adjunct to other drugs in managing epilepsy.
poster:Dan Perkins
thread:436336
URL: http://www.dr-bob.org/babble/20041228/msgs/436374.html