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NuPathe Says FDA Seeks More Data On Migraine Patch - Update

Specialty pharma company NuPathe Inc. (PATH) Tuesday said the U.S. Food & Drug Administration has sought additional data, while considering the company's New Drug Application for its migraine patch NP101 or Zelrix. The stock is falling over 49 percent in pre-market trading.

The company has received a Complete Response Letter, or CRL, from the FDA, which contains chemistry, manufacturing and safety questions.

The company believes it has or shortly will have, sufficient data to address the questions raised in the CRL and may conduct additional Phase I and/or non-clinical studies to address other questions.

The regulator acknowledged that NuPathe established the efficacy of the migraine patch in the overall migraine population.

The patch is an active, single-use transdermal system that delivers sumatriptan, the most prescribed migraine medication, for the treatment of migraine. The NDA was submitted in October 2010.

NuPathe said it would request an End-of-Review meeting with the agency to discuss the CRL and the company's approach to resolving the outstanding issues. As a result of the CRL, NuPathe will not launch its migraine patch in the first half of 2012, as previously announced.

Jane Hollingsworth, CEO of NuPathe, said, "This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner. We continue to believe that our patch will address the symptoms of millions of patients who suffer from debilitating migraine headache pain and migraine-related nausea. We look forward to working with the FDA to bring this important product to market."

PATH, which closed at $4.05 on Monday, is falling 49.37 percent in pre-market activity to $2.05.

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