Shire Takes Proactive Stance Regarding Daytrana Skin Patches

Implications: 1. Shire has withdrawn patches that had defective patch liners. 2. This defect is not related to safety or efficacy issues. 3. The cost to Shire is less than $10 million.

Analysis: More recently my patients have reported a lower incidence of skin problems with the Daytrana patch. If clinicians hear less complaints from their patients they will be more likely to prescribe this agent. This agent has relatively fewer systemic side effects than other stimulants (bypassing first-pass liver metabolism) that are administered orally with the exception of skin irritation at the patch site. This is the only stimulant that the patient has the choice of determining the duration of action by removing it 3 hours before the desired end time. The action of recalling defective patches will increase confidence in Daytrana and help bolster prescribing of this agent.
Daytrana, however, is currently being overshadowed by the newly released Vyvanse, a novel long acting prodrug for the treatment of ADHD. Because of the tremendous effort behind the promotion of Vyvanse I doubt there will be a significant impact on the Daytrana market.
Another benefit that Shire will reap from correcting any defects in patch technology is that there will be more confidence in this technology in a few years when an amphetamine salt patch borrowing this technology could potentially be promoted by Shire.