- From the Department of Pharmacy An estimated 30.3 mil- 2019, a simpler method of administra- lion individuals in the U.S. are diabetic tion, intranasal (IN) glucagon with 1.5 million having Type 1 diabetes (Baqsimi™; Eli Lilly), was approved by (T1DM); a reported 6 million of these the Food and Drug Administration diabetic patients use insulin, putting (FDA) for the treatment of severe hypo- them at higher risk for hypoglycemia glycemia in patients with diabetes (plasma glucose ≤70 mg/dL). 1,2 Severe ≥4 years old. 4 hypoglycemic events can result in cog- : Glucagon, the nitive dysfunction, unconsciousness, counter-regulatory hormone to insulin, and seizures which render the patient activates hepatic glucagon receptors unable to self-treat with oral carbohy- which stimulate glycogen breakdown drates requiring assistance from a care- leading to glucose release, ultimately giver. 2,3 Currently, the treatment for increasing blood glucose levels. 4 severe hypoglycemic episodes is intra- muscular (IM) glucagon which is availa- : The approval of IN glucagon was based on two adult and ble as GlucaGen ® Hypokit (Novo 5 Nordisk) and Glucagon™ Emergency Kit one pediatric clinical trial. The two adult trials had randomized, multi- (Eli Lilly). Due to poor stability of glu- center, open-label, two-period cross- cagon in solution, both products re- over, noninferiority designs. One adult quire reconstitution immediately prior trial only included patients with T1DM to injection by a caregiver or bystander (N=66) while the other included pa- resulting in a complex preparation and tients with both T1DM (n=77) and Type administration process. 3 On July 24, (Continued on page 2) - In the U.S. major de- sufLicient period of time. 3 Ketamine has pressive disorder (MDD) is the second been used successfully for TRD but re- most common psychiatric condition quires intravenous (IV) administra- with a lifetime prevalence between 6% tion. 4 Intranasal (IN) esketamine and 16%. 1 More than 50% of patients (Spravato™ Janssen Pharmaceutical), a From the Department of Pharmacy with MDD do not fully respond to initial more convenient form of ketamine, was Drug Information Service therapy and 30-50% of those non- approved in February 2019 by the Food responders exhibit symptoms of treat- and Drug Administration (FDA) as ad- (216) 444-6456, option #1 ment-resistant depression (TRD). 2 junctive therapy to an oral antidepres-
Treatment-resistant depression has sant for TRD in adults. 4 Comprehensive information about been deLined as failure to respond to medications, biologics, nutrients, two or more successive trials of medi- Research on and drug therapy cations from different pharmacologic mood disorders has demonstrated that classes given at adequate doses for a (Continued on page 3) (Continued from page 1) 2 diabetes (T2DM) (n=6); only the results from the - T1DM cohort of the second trial are published. Each patient was randomized to either 1 mg IM or 3 mg IN glucagon on dosing visit one followed 1 -4 weeks later by a second visit in a cross -over fashion to receive the opposite dosage form. During each visit, the patient’s - insulin therapy was discontinued (i.e., insulin pump suspended, basal insulin not given within 24 hours) - following an 8 hour fast and their blood glucose was - reduced to <60 mg/dL using an insulin infusion. Five - minutes after the insulin infusion was discontinued, IN - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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