Setback for Pfizer drug Lyrica
In a setback for Pfizer, the FDA said it would classify its newly approved nerve pain drug Lyrica as a controlled substance.
Pfizer had been counting on Lyrica to offset declines in Neurontin, which saw patent expiration last year. But under the new controlled substance classification, Lyrica would be subject to the rules of the Drug Enforcement Agency and be more difficult to prescribe and dispense than generic Neurontin, known chemically as gabapentin.
Lyrica was approved to treat pain from nerves damaged by diabetes and shingles last week. The FDA is still reviewing the drug as an aid to managing epileptic seizures.
A Pfizer spokeswoman told The Wall Street Journal the launch date and price for Lyrica couldn't be determined until the DEA completes its review – a process that could take weeks or months. The spokeswoman declined to comment on what triggered the controlled substance classification.