Posted by zmg on January 24, 2005, at 20:35:14
In reply to Any new Pregabalin - Lyrica Experiences?, posted by TheOutsider on January 24, 2005, at 12:35:05
It looks to me like the problem with Lyrica is probably two fold 1) its been scheduled a controlled substance 2) it wasn't approved for seizures or anxiety disorders.
It seems like a doctor might be less inclined to prescribe this off label. Any doctors?
Sounds like a fairly big defeat for Pfizer:
"First, federal regulators designated Lyrica as a controlled substance. As a drug subject to the rules of the Drug Enforcement Administration, statutory requirements for prescribing controlled substances are likely to make it less attractive in the eyes of some patients and physicians. Neurontin is not classified as a controlled substance, putting generic gabapentin manufacturers in a better selling position versus Lyrica despite fewer indications. The therapeutic benefit of Lyrica as compared to Neurontin is not dramatic, and this classification will only make Lyrica a harder drug to advertise and prescribe, making doctors more inclined to prescribe generic gabapentin.
Second, the major selling point for the product (expanded labeling) has not developed in the desired fashion Pfizer had intended. The FDA has reviewed Lyrica for four different indications -- neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia, as an add-on therapy in the treatment of partial epileptic seizures, and for the treatment of generalized anxiety disorder in adults. Lyrica was only cleared for neuropathic pain due to diabetes and postherpetic neuralgia. The FDA has rejected Lyrica as a treatment for epileptic convulsions and anxiety. If Pfizer had gotten all the indications it was seeking for Lyrica, the drug could have been positioned not only as a first-line therapy for neuropathic pain and epilepsy but also as a viable substitute for benzodiazepines in the lucrative anxiety market. Anxiety disorders are considered the most prevalent of psychiatric disorders. An estimated 19 million adult Americans suffer from anxiety disorders. Generalized anxiety disorder is one of the prevalent anxiety disorders and affects 4 percent of the U.S. population."
poster:zmg
thread:446798
URL: http://www.dr-bob.org/babble/20050124/msgs/447063.html