Phathom submits 6-month stability data for vonoprazan NDA; NVP impurity controlled below limit

Phathom Pharmaceuticals, Inc.

Submitted 6-month stability data for reformulated vonoprazan tablets to FDA for Erosive GERD NDA.
NVP (nitrosamine impurity) kept >10-fold below acceptable daily intake limit of 96 ng/day (2.4 ppm) through 6 months.
PDUFA goal date for NDA resubmission (Class 2) is November 17, 2023.
If approved, combined US launch for Erosive GERD and H. pylori planned for Q4 2023.
Data addresses CRL issued Feb 2023 regarding specifications/controls for NVP impurity.

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