Ready-to-Use Rescue Pen for Severe Hypoglycemia Moves Closer to Approval
Xeris Pharmaceuticals announced the completion of two Phase 3 studies of an investigational ready-to-use rescue pen for the treatment of severe hypoglycemia in patients with diabetes.
The pen is a liquid-stable glucagon auto-injector, developed using the Company's proprietary technology, XeriSol. The full findings of the trials will not be released until later this year, however the Company stated that the trials were a success, with the data already shared with the FDA in a pre-New Drug Application (NDA) meeting.
Results from a Human Factors usability and reliability study showed that 99% of individuals could successfully administer the Xeris rescue pen. Full results of the Human Factors trial will be presented at the Advanced Technologies and Treatments for Diabetes conference in Vienna.
“Xeris is on-track to submit an NDA for our ready-to-use glucagon rescue pen for the treatment of severe hypoglycemia in late Q2 of this year,” said Paul Edick, President and CEO of Xeris. The Company has also initiated a Phase 3b study. This trial will focus on preparation and administration time of current emergency kits vs. the Xeris rescue pen.
For more information visit Xerispharma.com.