A Possible New Drug for Postmenopausal Osteoporosis

Tibin K. Titus, Mercer University College of Pharmacy

Postmenopausal osteoporosis occurs due to estrogen deficiency resulting in an increase of mature osteoclasts, which will increase bone resorption into the blood. [1] Simultaneously, there is a decrease in calcium absorption and increase in calcium excretion through the gut. [1] Romosozumab is a new monoclonal antibody that is in development for treatment of osteoporosis in postmenopausal women at increased risk of fractures. [2] In a previous trial, romosozumab reduced the risk of fracture compared to placebo; however, it has not been compared with an active comparator. [2] This study was conducted with an active comparator, alendronate, to compare the two drugs for fracture prevention in postmenopausal women with osteoporosis. [3]

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Adasuve for the Rapid Treatment of Agitation in Schizophrenia

JoAnn Filipov, Mercer University College of Pharmacy

Limited options of antipsychotic drug administration exist in the current standard of care for the acute treatment of agitation. [1] According to the Expert Consensus Guidelines for Treatment of Behavioral Emergencies, speed of onset is key in choosing medication administration route. [2] Since intravenous administration of antipsychotics necessitates established intravenous access, oral and intramuscular administrations are more prominently used. However, oral and intramuscular formulations have a more gradual onset of action, unlike intravenous pharmacokinetics, thus allowing for symptoms to escalate before they begin to resolve. [3] It is reported that patients with an episode of acute agitation often resist intramuscular administration, further escalating the risk of intensifying symptoms. Therefore, there is a need for anti-agitation medications with rapid onset of action and acceptable safety profile that are easy to administer. [4]

Loxapine, an antipsychotic indicated for the treatment of schizophrenia. [5] Loxapine is available as a capsule and intramuscular injection formulations, that have demonstrated efficacy in the treatment of agitation. [6] Due to the unmet need, a new formulation of loxapine, AdasuveÒ, was developed that can be inhaled via Staccato inhalation system. The system is shown to distribute loxapine with intravenous-like pharmacokinetics. [7] Below article summarized the efficacy and safety of Adasuve®. [8]

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Canagliflozin vs Placebo in Type 2 Diabetes for CV and Renal Events

Achal Patel, Mercer University College of Pharmacy

Type 2 diabetes (T2D) is the more common form of diabetes mellitus compared to type 1 diabetes (T1D) and accounts for ~90% of all diabetes patients. [1] Complications of diabetes include cardiovascular, macrovascular, microvascular, peripheral nerve, and renal diseases. Evidence shows that use of SGLT2 inhibitors may help in reducing the risk of cardiovascular complications, albuminuria, and renal diseases. [2]

Canagliflozin (Invokana®), is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers the renal threshold for glucose and increases urinary glucose excretion by interfering with the reabsorption of renally-filtered glucose across the tubular lumen of the proximal renal tubules. [3] Sodium-glucose cotransporter 2 inhibitors are the most recent type of diabetic agents approved for T2D management in the U.S. Previously, the Food and Drug Administration published a guidance for industry that new diabetic agents should be assessed for their cardiovascular safety. [2] The article below summarizes two canagliflozin trials that assessed its effect on CV risks (CANVAS) and albuminuria (CANVAS-R).

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Efficacy, Acceptability, and Safety of Atypical Antipsychotics in First Episode Schizophrenia

Achaia Taltoan, Mercer University College of Pharmacy

The American Psychiatric Association (APA) schizophrenia guidelines recommend all second-generation (“atypical”) antipsychotics as first-line treatment for first episode schizophrenia. [1] Unlike the APA guidelines, the 2009 schizophrenia PORT statements recommend risperidone, quetiapine, aripiprazole, and ziprasidone as first line therapy but not olanzapine due to the associated metabolic side effects. [2]

While trials such as the EUFEST and the CATIE trial have compared second-generation antipsychotics to first-generation antipsychotics, there is a lack of guidance whether one second-generation antipsychotic is better than the other in certain situations for the treatment of first episode schizophrenia. [3] This trial attempts to provide data to enhance the understanding of the efficacy, discontinuation rate, and adverse events of the second-generation antipsychotics in comparison with one another.

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A Novel drug, Ingrezza, for the Treatment of Tardive Dyskinesia

JoAnn Filipov, Mercer University College of Pharmacy

Tardive Dyskinesia is an involuntary movement disorder induced by continued exposure to dopamine receptor agents (DBRAs). It is associated with persistent, hindering physical conditions causing significant problems for psychiatric patients. [1] Second-generation (“atypical”) antipsychotics were thought have a decreased risk for tardive dyskinesia compared to first-generation antipsychotics, but current literature indicates the risk may be increased with both generations. [2] For management, the two main methods are: 1) reduce the antipsychotic dose or 2) discontinue the drug. However, literature suggests both may not be the best strategies as they may lead to suboptimal management of the psychiatric illness without resolving tardive dyskinesia. [3]

Vesicular monoamine transporter 2 (VMAT 2) inhibitors (e.g. tetrabenazine) have been used to treat movement-related symptoms of Huntington’s disease. [4] They regulate presynaptic packaging and dopamine release into the synapse. Due to this mechanism of action, it was proposed that VMAT2 inhibitors may be able to counterbalance involuntary movement side effects of antipsychotics. [5] Research sparked to develop valbenazine (Ingrezza Ò). Its exact mechanism of action is unknown; however, it is thought to reversibly inhibit VMAT2. [6] In 2017, the Food and Drug Administration approved valbenazine for the treatment of tardive dyskinesia in adults. Below summarizes the phase 3 trial of valbenazine. [7]

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Degludec Versus Glargine in Type 2 Diabetes for CV Risk

Tibin K. Titus, Mercer University College of Pharmacy

Type 2 diabetes affects millions of people worldwide. [1] Among the complications that arise from diabetes are cardiovascular (CV) complications such as stroke, coronary heart disease, and vascular disease. [1] Additionally, studies have shown that type 2 diabetics who require insulin have increased rates of cardiovascular events. [2,3]

Degludec is a new and ultra long acting basal insulin that came into the market in 2016. It is approved for glycemic control in type 2 diabetes. The Food and Drug Administration (FDA) requires all new diabetes drugs to have a CV risk study. [6] To fill the gap in knowledge for the CV safety of degludec, the following study was conducted. [7]

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Sotagliflozin Added to Insulin in Type 1 Diabetics

Shanterra Grable, Mercer University College of Pharmacy

Type 1 diabetes, previously considered juvenile diabetes, affects approximately 29 million adults worldwide. It develops when the pancreas stops producing insulin, eliminating the body’s ability to maintain glucose control. The autoimmune disease can have a rapid onset and must be managed with insulin administered via injection or by pump.  It is  approximated that less than one-third of people living with type 1 diabetes achieve the target A1c of less than 7%. [1]

Sotagliflozin is the newest agent in a class of antidiabetic agents known as sodium –glucose cotransporter 1 and 2 (SGLT2) inhibitors. Prior phase two studies on sotagliflozin have shown improved glycemic control, reduced body weight, and reduced glycemia in both type 1 and type 2 diabetics. None of the current medications on the market are approved for use in conjunction with insulin to lower glucose in type 1 diabetic patients. The inTandem3 phase three trial evaluated the effects of sotagliflozin when used in combination with insulin on glycemic control, instances of severe hypoglycemia, and diabetic ketoacidosis in adults with type 1 diabetes. [2]

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