2020-10-21 08:34:02 ZSAN Zosano Pharma
10/21/20 10/2108:34 10/21/2008:34 | Zosano Pharma says FDA recommends repeat bioequivalence study for QtryptaZosano Pharma announced that it has received a complete response letter from the U.S. Food and Drug Administration in connection with the Qtrypta 505(b)(2) New Drug Application. The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies, which had been previously identified in the FDA's discipline review letter in September. Specifically, the CRL noted differences in zolmitriptan exposures observed between subjects receiving different lots of Qtrypta in the company's trials and inadequate pharmacokinetic bridging between the lots that made interpretation of some safety data unclear. The CRL referenced unexpected high plasma concentrations of zolmitriptan observed in five study subjects enrolled in the company's pharmacokinetic studies. The FDA recommended that the company conduct a repeat bioequivalence study between three of the lots used during development. The NDA included data on a total of 774 subjects across 5 trials who were administered or dosed with Qtrypta. The CRL noted that additional product quality validation data, which were planned to be submitted following approval, if received, were required to be submitted with the application. In addition, the CRL mentioned that due to U.S. Government and/or Agency-wide restrictions on travel, inspections of Zosano's contract manufacturing facilities were not able to be conducted but would be required before the application may be approved. Zosano will request a Type A meeting with the FDA to discuss strategies to address the FDA's comments. |
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