On Monday, the FDA is scheduled to make a decision about NuPathe's (Nasdaq: PATH ) migraine patch Zelrix -- assuming, of course, that the hurriquake doesn't cause the agency to miss its PDUFA goal.
The patch delivers sumatriptan, originally developed by GlaxoSmithKline (NYSE: GSK ) as Imitrex but now off patent, so the agency should be comfortable with the efficacy and side effects of the medication. In fact, the reason for using a patch is to decrease the side effects and avoid pills for patients that may be nauseous while they're having a migraine.
But Zelrix isn't like your typical transdermal patch -- such as Glaxo's NicoDerm or Novartis' (NYSE: NVS ) Exelon Patch, for example -- that releases the drug slowly into the bloodstream. In order to get the drug into the body relatively quickly, NuPathe's patch requires an electronic pulse to deliver the medication through the skin.
The biggest risk for investors when drugs face FDA decisions is in the manufacturing. Unlike clinical trial data that's usually published, investors have essentially no view into that aspect of the approval process. That goes double for an electronic patch, which is considerably more complex to manufacture than a simple small-molecule pill.
Johnson & Johnson (NYSE: JNJ ) ran into manufacturing problems with its electronic pain patch, Ionsys, which may cause an increased scrutiny. The FDA will want to ensure Zelrix is delivering the correct dose and that the chance of a malfunction is essentially zero. It's difficult to know whether the reviewers will find anything, but investors shouldn't take the risk too lightly.
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