Xeris Pharmaceuticals announces results from Phase 1 diazepam study

Xeris Pharmaceuticals announced findings from a Phase 1 study of its formulation of diazepam. The Phase 1, open-label, three-treatment, three-way crossover, randomized controlled study was conducted among 24 healthy volunteers to assess the bioavailability and pharmacokinetics, or PK, of Xeris’ novel formulation of diazepam after intramuscular, or IM, and subcutaneous, or SC, administration compared to an administration of commercial diazepam rectal gel. Secondary objectives were to assess the safety and tolerability of Xeris’ diazepam after SC and IM administration. Xeris’ IM and SC administration of 10 mg diazepam yielded higher exposure as compared to an equivalent dose of diazepam rectal gel as assessed by AUC 0-8. In individual comparisons, Xeris’ IM administration resembled diazepam rectal gel for both Cmax and Tmax. Additionally, both Xeris arms were safe and well-tolerated as a single dose. The study found no safety trends in any treatment group. Based on these results, Xeris anticipates initiating a Phase 2 open-label, single-arm, weight-based dosing study with IM administration of diazepam in patients with seizure disorders in the second half of 2019.

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