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SBH14 emails to ask, "Adam, do you predict Nupathe's (PATH) migraine patch will receive FDA approval?"

Nupathe's Zelrix is a patch that uses electric current (via a small battery and chip) to actively push the commonly used migraine medicine sumatriptan through the skin and into the patient's bloodstream.

Migraines are an acute, episodic condition, and patients typically seek pain relief as fast as possible, which is why sumatriptan pills (like GlaxoSmithKline's ( GSK) Imitrex, now generic) dominate the migraine treatment market. Injectable sumatriptan is also used for even faster pain relief.

A drug patch, even one that actively delivers sumatriptan through the skin like Nupathe's Zelrix, is not going to be quickest or most effective pain reliever. The data from Nupathe's registration studies bear this out. Zelrix's efficacy -- measured by migraines patients reporting either no pain after two hours or reduced pain after two hours -- definitely lags out-of-study comparisons to injectable and oral sumatriptans.

Fortunately for Nupathe, its registration studies compared Zelrix to a placebo, the results of which strongly favored Zelrix. Nupathe Chief Financial Officer Keith Goldan says the FDA asked the company specifically to conduct placebo-controlled studies and did not ask for or require studies against an active comparator for approval purposes.

From a pure efficacy standpoint, Zelrix shouldn't have trouble getting approved. (That's as long as the FDA remains copacetic with placebo-controlled studies.) The approval risk that remains is on the device and safety side. Will the Zelrix patch, with its computer chip and battery, raise enough manufacturing or quality assurance concerns with FDA reviewers to delay approval? It's possible.

The safety data on Zelrix from the clinical studies seem relatively benign, with the exception of an increase in pain and skin irritation where the patch is applied, but again, it's hard to say where FDA balances the risk and benefit here since delaying approval of Zelrix won't necessarily harm migraine sufferers who already have a plethora of treatment options.

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