NuPathe to resubmit migraine patch for approval in 2012

NuPathe (NASDAQ: PATH) said it will resubmit a new drug  application for its transdermal migraine patch for approval by the U.S. Food and Drug Administration after receiving a complete response letter from the regulator, according to the company’s third quarter earnings report.

NuPathe said the issues raised in the August 29 letter from the FDA and in a subsequent meeting Nov. 9 to clarify points raised by the letter were tied to the patch’s chemistry and manufacturing. A complete response letter means the FDA won’t approve a drug candidate without additional information.

Jane Hollingsworth, NuPathe’s CEO, said on a conference call with analysts that the meeting confirmed the company’s belief that it has the data necessary to resubmit.  The chemistry issue involved confirming the uniformity of dosage which involved confirming that the patch performed equally well whether it was stored vertically or horizontally.

Migraine headaches affect about 31 million adults in the United States. Symptoms include moderate to severe headache pain, nausea and vomiting, photophobia, or abnormal sensitivity to light, and phonophobia, or abnormal sensitivity to sound, the company said.


For migraine treatment, the patch transmits sumatriptan through the skin using a “controlled delivery technology” that uses a mild electrical current in a process called iontophoresis.

Hollingsworth said the emerging biopharmaceutical company has made “considerable progress towards resolving the agency’s questions.” She said it would resubmit its new drug application in the first half of 2012 and would use the extra time to improve its product and ready launch preparations.

To hasten the resubmission of the NDA, the company is shifting resources from its NP202, a drug for the long-term treatment of schizophrenia and bipolar disorder, to NP101, the migraine patch.  As a result, NuPathe expects to delay the submission of its Investigational New Drug application for the schizophrenia and bipolar disorder drug to 2013 instead of next year as previously planned.

On the call, Hollingsworth said one issue that had come up was a long-term mark on the skin by some patch users caused by improper application of the patch. She noted that a solution to the problem was being devised. A new feature will prevent the patch from being activated unless it is applied correctly. She said, “Device enhancement is not something we need to do, but we absolutely feel we can eliminate this as a potential issue so may as well use this time to do it.”

NuPathe also has another proprietary product candidate including NP201 for the continuous symptomatic treatment of Parkinson’s disease, which the company plans to partner.

Among the investors in NuPathe are Safeguard Scientifics (NYSE: SFE), which has an 18 percent stake, GlaxoSmithKlein‘s (NYSE:GSK) venture capital arm, SROne, along with Quaker BioVentures, BioAdvance, Battelle Ventures.

On November 9, we held a meeting with the FDA to discuss the CRL and, based on this discussion, we have a clear understanding and plan to address the remaining issues required for approval.  We now intend to resubmit our NDA in the first half of 2012 and will use the time between now and approval to continue our launch preparation, including our efforts to broaden physicians’ awareness of the burden of migraine-related nausea.”

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