Thursday, December 23, 2004

Provigil. Attenace. Nuvigil.

When a refreshing midday snooze isn't a possibility, some people are taking a medication described as "a nap in a pill" called Provigil (modafinil). Provigil is approved for sleep apnea, narcolepsy and shift work sleep disorder, but not for avoiding sleep. Cephalon's patents on Provigil last until 2014.

On December 22, 2004 Cephalon Inc. has asked the FDA to approve a version of its narcolepsy drug Provigil to be used to treat children with attention deficit hyperactivity disorder. The drug would be marketed as Attenace. If the Food and Drug Administration approves Attenace, Cephalon will receive a patent on the drug that lasts until 2020. Because Attenace is a different dose of modafinil than Provigil, the FDA treats it as a different drug.

In the context of continuing medical education (CME), lecturing doctors can answer questions about off-label uses, although they cannot initiate discussion of off-label uses. Thus, in the past, if someone asked about using modafinil for ADHD, the lecturing doctor could respond.

As noted elsewhere on IPBiz, Provigil is a racemate, and Nuvigil is a single enantiomer of the Provigil racemate.


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