Levadex is delayed again

Approval of the inhaled dihydroergotamine or DHE to be sold under the name of Levadex has been delayed again by the FDA. We expected approval last year because the FDA did consider the product to be safe and effective, but they were not happy with the manufacturing process. The application for approval was resubmitted and we all expected the product to become available in the middle of this year, but apparently the FDA still has the some concerns about the manufacturing. If all goes well Levadex may come to the market at the end of 2013. In the past few months the small company that developed Levadex, MAP Pharmacueticals sold itself to the maker of Botox, Allergan. Allergan hopes to find synergy between Botox, which is approved for the prevention of chronic migraines and Levadex, which is indicated for the treatment of an acute migraine attack. It will be much more efficient for Allergan’s sales force to sell two complementary drugs to neurologists rather than just one. Both are excellent drugs with high efficacy (70% for Botox and 60% – 70% for Levadex), excellent safety for Botox and relatively good safety for Levadex (comparable to triptans, such as Imitrex).

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