-=Zosano Pharma (ZSAN) received discipline review letter for Qtrypta NDA

 

Zosano Pharma receives discipline review letter from the FDA in connection Qtrypta NDA; approval of Qtrypta is not expected by the October 20 PDUFA date 

Zosano Pharma has received a discipline review letter (DRL) from the FDA in connection with the Qtrypta (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application (NDA). A DRL is used by the FDA to convey preliminary comments on deficiencies identified during the NDA review with respect to a particular review discipline.

The DRL described two concerns with respect to the clinical pharmacology section of the NDA.

• First, the FDA raised questions regarding unexpected high plasma concentrations of zolmitriptan observed in five study subjects from two pharmacokinetic studies and how the data from these subjects affect the overall clinical pharmacology section of the application.
• Second, the FDA raised questions regarding differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's clinical trials.

Although a DRL reflects preliminary comments that are subject to change, and does not reflect the FDA's final decision on the NDA, approval of Qtrypta by the Prescription Drug User Fee Act goal date of October 20, 2020 is not expected given the letter.