NuPathe slumps as US FDA calls for more info on migraine patch Zelrix
Shares in USA-based NuPathe (Nasdaq: PATH) plunged as much as 56% to $1.80 in morning trading yesterday after the company revealed that it has received a Complete Response Letter from the US Food & Drug Administration regarding the New Drug Application for its sumatriptan-based migraine patch Zelrix (NP101). The active ingredient, now off patent, was developed by UK pharma giant GlaxoSmithKline and sold as Imitrex.
In the CRL, the agency acknowledged that NuPathe established the efficacy of the migraine patch in the overall migraine population. The CRL primarily contained chemistry, manufacturing and safety questions, which the company believes it has, or shortly will have, sufficient data to address.
First-half 2012 launch no longer targeted
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