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Zosano Pharma files for US FDA approval of migraine therapy

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Zosano Pharma files for US FDA approval of migraine therapy

Zosano Pharma Corp. filed an application with the U.S. Food and Drug Administration seeking approval of its non-oral migraine therapy Qtrypta.

The Fremont, Calif.-based biopharmaceutical company said Qtrypta is a formulation of the migraine drug zolmitriptan which is delivered through the company's proprietary Adhesive Dermally-Applied Microarray technology that consists of microneedles coated with the medicine.

A migraine is a powerful headache that among other things may happen with nausea, vomiting and sensitivity to light.

Zosano said in a Dec. 23 press release that the new drug application was backed by data from a phase 2/3 trial, dubbed Zotrip, which showed that the therapy helped patients achieve pain relief.

The company expects to hear from the FDA in March 2020 on whether the submission was accepted for review.