FDA delay for MAP Pharma migraine drug candidate

28 March 2012

Shares of USA-based MAP Pharmaceuticals (Nasdaq: MAPP) plunged 24% to $13.01 in early trading yesterday, after the firm said it has received and Complete Response Letter from the Food and Drug Administration relating to its migraine drug candidate Levadex (dihydroergotamine) inhalation aerosol.

The product is being developed for the US market with drugmaker Allergan (NYSE: AGN) under a deal that could earn MAP as much as $157 million, $60 million of which was paid up front (The Pharma Letter February 2, 2011).

In the CRL, the FDA requested that MSP address issues relating to chemistry, manufacturing and controls (CMC) and observations from a recent facility inspection of a third party manufacturer. The agency also indicated that it had not been able to complete review of inhaler usability information requested late in the review cycle by the FDA.

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