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Five-year exclusivity for Vyvanse affirmed

The US FDA has completed a review and affirmed its prior decision to grant five-year New Chemical Entity exclusivity to lisdexamfetamine dimesylate

The US Food and Drug Administration (FDA) has completed a review and affirmed its prior decision to grant five-year New Chemical Entity (NCE) exclusivity to lisdexamfetamine dimesylate.

Currently marketed under the name of Vyvanse by Shire US for the treatment of attention deficit hyperactivity disorder (ADHD), the five-year exclusivity period will expire on June 29, 2012 while US patents remain in effect until June 29, 2023.

On February 23, 2007, after reviewing clinical studies, the FDA authorised that Vyvanse qualified as an NCE and gave it five-year market exclusivity, thereby refusing to file an Abbreviated New Drug Application submitted by Actavis for lisdexamfetamine dimesylate.

Last week Shire announced new data about the pharmacokinetics of Vyvanse, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or orally. Specifically, the overall rate and extent of exposure to d-amphetamine, the active medication in Vyvanse, was similar in healthy adults whether they received the drug as a solution through the nose or orally as a capsule.

These findings, which were recently presented at a major psychiatric meeting, reflect the ongoing efforts of Shire to further understand the abuse potential of Vyvanse. (Vyvanse is indicated for oral administration only, and should not be administered intranasally.)

Shire is currently undergoing a major transition within the company as Adderall XR – again for the treatment of ADHD - has seen sales slip 77 per cent in the last quarter due to competition. In 2006 Shire agreed to sell the rights to the Adderall name for an instant-release medication and more recently Shire's inability to extend the patent life of Adderall XR, means that the drug has become available in generic form from April 2009.

26th October 2009


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