New seizure medicine may be approved soon

Pfizer Inc announced in late October, 2003, that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking approval for a new seizure medicine called pregabalin (pree-gab-uh-lin). Pregabalin has been tested as an add-on (adjunctive) treatment for people with partial seizures that are not well controlled by other medications.

An NDA is the final step before the FDA authorizes a medication to be sold in the United States. This application gives the FDA complete information on the history of the medicine, including details about clinical trials that have tested the medicine in patients. The time between filing of an NDA and approval of a new medicine for sale averages at least 1 year.

As reported at the annual meeting of the American Epilepsy Society in December 2001, pregabalin was tested in hundreds of patients who were experiencing uncontrolled partial seizures (with or without secondary generalization) even though they were taking one to three other seizure medicines. (Half of the patients were taking two others.) For many of these difficult-to-treat patients, pregabalin reduced the number of seizures significantly (often by more than half) and the side effects were usually mild. When offered the opportunity to continue taking pregabalin at the conclusion of the double-blind study, a large majority of the patients chose to do so, and the pregabalin continued to work well after at least 8 months of use. A similar study in Europe had the same kind of results.

Pfizer is also seeking approval from the FDA for two other uses of pregabalin in addition to controlling partial seizures in epilepsy:

• management of pain associated with diabetes (diabetic peripheral neuropathy) or shingles (post-herpetic neuralgia)
• treatment of generalized anxiety disorder.

Pfizer has also applied for approval of pregabalin by regulatory authorities in Europe. A committee approved the drug in April 2004, and the European Commission may soon authorize marketing of the drug. A decision is expected as early as June 2004. It would be sold under the brand name Lyrica.