The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Qtrypta™ (M207) (zolmitriptan intracutaneous microneedle system; Zosano Pharma) for the acute treatment of migraine.

Qtrypta delivers zolmitriptan, a selective 5-HT1B/1D receptor agonist, using the Company’s proprietary Adhesive Dermally-Applied Microarray (ADAM) technology that consists of a drug-coated microneedle patch. The drug-coated microneedles penetrate into the epidermis and dermis where the drug dissolves and enters the bloodstream.

The application is supported by data from the multicenter, double-blind, placebo-controlled, phase 2/3 ZOTRIP study that evaluated the efficacy and safety of Qtrypta in 333 patients for the acute treatment of migraine. Patients were randomized to receive either Qtrypta (1mg, 1.9mg, and 3.8mg) or placebo. The co-primary end points were the proportion of patients with pain freedom and freedom from most bothersome symptom (MBS) at 2 hours post dose.

Results showed that the 3.8mg dose was associated with statistically significant improvements in pain freedom and MBS freedom compared with placebo. At 2 hours, 41.5% of patients treated with Qtrypta 3.8mg achieved pain freedom and 68.3% achieved MBS freedom, compared with 14.3% and 42.9% of patients in the placebo group, respectively.

Redness at the application site was the most common treatment-emergent adverse event, according to long-term safety data.

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Zosano is seeking approval through the 505(b)(2) regulatory pathway, an abbreviated approval pathway that allows for some of the information required for approval to come from studies related to zolmitriptan. “This submission also represents the first NDA to be submitted to the FDA for a pharmaceutical microneedle patch,” said Steven Lo, President and Chief Executive Officer of Zosano. “We believe this technology, if approved, has the potential to transform how drugs, biologics and vaccines are delivered, and we look forward to further discussions with the FDA during its review of this submission.”

A Prescription Drug User Fee Act (PDUFA) target date of October 20, 2020 has been set for this application.

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