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NuPathe shares plunged as much as 56 percent Tuesday after the company announced it received a complete response letter from the FDA regarding its application for the Zelrix (sumatriptan) migraine patch. The company indicated it may conduct additional trials to address questions raised in the letter, and as a result, will not launch Zelrix in the first half of 2012 as expected.

In the correspondence, the US regulator raised chemistry, manufacturing, and safety questions, "which the company believes it has, or shortly will have, sufficient data to address," NuPathe stated. The drugmaker said that it may undertake additional Phase I or non-clinical trials "to address other questions."

The company noted that regulators acknowledged that efficacy of the migraine patch had been established in the overall migraine population. In October, NuPathe announced data from a 12-month study that demonstrated Zelrix relieved migraine headache pain in a majority of incidences.

Commenting on the market potential of the drug, which was expected to garner peak annual sales of $250 million, Needham & Co analyst Elliot Wilbur said "the availability of numerous inexpensive generic forms of migraine therapy products could limit acceptance of Zelrix with patients and within the medical community."

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