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    v: **BACKGROUND:** Glucagon nasal powder (GNP), a novel intranasal formulation of glucagon being developed to treat insulin-induced severe hypoglycemia, contains synthetic glucagon (10% w/w), beta-cyclodextrin, and dodecylphosphocholine. The safety of this formulation was evaluated in four studies in animal models. **METHODS:** The first study evaluated 28-day sub-chronic toxicology in rats treated intranasally with 1 and 2 mg of GNP/day (0.1 and 0.2 mg glucagon/rat/day). The second study evaluated 28-day sub-chronic toxicology in dogs administered 20 and 40 mg of formulation/dog/day (2 and 4 mg glucagon/dog/day) intranasally. A pulmonary insufflation study assessed acute toxicology following intra-tracheal administration of 0.5 mg of GNP (0.05 mg glucagon) to rats. Local tolerance to 30 mg of GNP (equivalent to 3 mg glucagon, the final dose for humans) was tested through direct administration into the eyes of rabbits. **RESULTS:** There were no test article-related adverse effects on body weight and/or food consumption, ophthalmology, electrocardiography, hematology, coagulation parameters, clinical chemistry, urinalysis, or organ weights, and no macroscopic findings at necropsy in any study. In rats, direct intra-tracheal insufflation at a dose of 0.5 mg of GNP/rat (0.05 mg glucagon/rat) did not result in adverse clinical, macroscopic, or microscopic effects. In dogs, the only adverse findings following sub-chronic use were transient (<30 s) salivation and sneezing immediately post-treatment and mild to moderate reversible histological changes to the nasal mucosa. Daily dosing over 28 days in rats resulted in mild to moderate, unilateral or bilateral erosion/ulceration of the olfactory epithelium, frequently with minimal to mild, acute to sub-acute inflammation of the lamina propria at the dorsal turbinates of the nasal cavity in 2/10 males and 3/10 females in the high-dose group (0.2 mg glucagon/day). These lesions resolved completely over 14 days. Histological exam…
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      v: ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. pnormand@itrlab.com.
entry:
  contributor:
    l: contributor2
    reference:
      v: #contributor2
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: McInally K
  forename initials:
    v: K
  affiliation:
    display:
      v: ITR Laboratories Canada Inc. (ITR), 19601 Clark Graham Blvd, Baie d'Urfe, Quebec, Canada. kmcinally@itrlab.com.
entry:
  contributor:
    l: contributor3
    reference:
      v: #contributor3
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Silo S
  forename initials:
    v: S
  affiliation:
    display:
      v: CiToxLAB North America, 445 Armand-Frappier Blvd, Laval, Québec, Canada. silos@ca.citoxlab.com.
entry:
  contributor:
    l: contributor4
    reference:
      v: #contributor4
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Stotland P
  forename initials:
    v: P
  affiliation:
    display:
      v: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. patricia.stotland@locemia.com.
entry:
  contributor:
    l: contributor5
    reference:
      v: #contributor5
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Triest M
  forename initials:
    v: M
  affiliation:
    display:
      v: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. myriam.triest@locemia.com.
entry:
  contributor:
    l: contributor6
    reference:
      v: #contributor6
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Carballo D
  forename initials:
    v: D
  affiliation:
    display:
      v: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. dolores.carballo@locemia.com.
entry:
  contributor:
    l: contributor7
    reference:
      v: #contributor7
    type:
      v: Practitioner
      l: Practitioner
    display:
      v: Piché C
  forename initials:
    v: C
  affiliation:
    display:
      v: Locemia Solutions ULC., 8505 Dalton, Montreal, QC, Canada. claude.piche@locemia.com.