FDAnews Drug Daily Bulletin


Jan. 6, 2005

Pfizer's highly anticipated nerve pain medication Lyrica received FDA approval Dec. 31, 2004, but the victory was somewhat bittersweet for the firm, as the agency decided to classify the drug as a controlled substance, which could negatively affect its sales.

Lyrica (pregabalin) is the first FDA-approved drug intended to treat neuropathic pain associated with diabetic peripheral neuropathy and postherpetic neuralgia (shingles), the company said. Pfizer is hoping the drug can offset decreased sales of its other nerve pain drug, Neurontin (gabapentin), which saw its patent expire last year and is now open to generic competition. However, unlike Neurontin, Lyrica has been classified as a controlled substance -- a designation that can affect sales because it imposes additional requirements on doctors and pharmacists administering the drug.

The FDA's classification of Lyrica as a controlled substance is also likely to delay the product's launch date because Pfizer must wait for the Drug Enforcement Administration (DEA) to conduct a formal review of the drug. A Pfizer spokeswoman said that the DEA review could take as short as a few weeks or as long as several months. A launch date won't be announced until the review is completed, she said.