New Drug Reviews
Topical Clascoterone: The First Novel Agent for Acne Vulgaris in 40 YearsAcne vulgaris is a ubiquitous condition in men and women starting in adolescence. It is often persistent and refractory to multiple treatment methods. Although multiple medications may be used on- or off-label for treatment, many adverse effects and risks exist with these treatments, and there has not been an agent with a novel mechanism of action introduced in 40 years. Clascoterone is a recently approved topical acne medication with the first novel mechanism of action since isotretinoin. The purpose of this article was to review the clinical data regarding the safety and efficacy of topical clascoterone for the treatment of acne vulgaris in male and female subjects aged >12 years.
Rational Use of Lasmiditan for Acute Migraine Treatment in Adults: A Narrative ReviewThis narrative review provides an update on the research that led to the development of ditans and lasmiditan for the acute treatment of migraine in adults and discusses the potential advantages and disadvantages of lasmiditan in clinical use.
Bempedoic Acid: A New Tool in the Battle Against HyperlipidemiaThis article discusses the pharmacology of bempedoic acid, the trials that led to United States Food and Drug Administration (FDA) approval of its use, and the overall safety and efficacy of this therapy in heterozygous familial hypercholesterolemia, established atherosclerotic cardiovascular disease (ASCVD), and hyperlipidemia.
Angiotensin II: A New Vasopressor for the Treatment of Distributive ShockAngiotensin II (ATII) is a potent endogenous vasoconstrictor that has recently garnered regulatory approval for the treatment of distributive shock, including septic shock. Traditional vasoactive substances used in the management of distributive shock include norepinephrine, epinephrine, phenylephrine, and vasopressin. However, their use can be associated with deleterious adverse drug effects, such as splanchnic vasoconstriction and associated hypoperfusion. The purpose of this review is to describe ATII, including its pharmacologic mechanisms, pharmacokinetic profile, evidence of efficacy and tolerability, and potential role in contemporary critical care practice.
A Systematic Review of Drug Therapies for Chronic Fatigue Syndrome/Myalgic EncephalomyelitisThe pathogenesis of chronic fatigue syndrome or myalgic encephalomyelitis (CFS/ME) is complex and remains poorly understood. Evidence regarding the use of drug therapies in CFS/ME is currently limited and conflicting. The aim of this systematic review was to examine the existing evidence on the efficacy of drug therapies and determine whether any can be recommended for patients with CFS/ME.
Ceftazidime-Avibactam: A Novel Cephalosporin/β-Lactamase Inhibitor Combination for the Treatment of Resistant Gram-negative OrganismsMultidrug-resistant gram-negative bacterial infections have emerged as a major threat in hospitalized patients. Treatment options are often inadequate and, as a result, these infections are associated with high mortality. A cephalosporin and a novel synthetic non–β-lactam, β-lactamase inhibitor, ceftazidime-avibactam, is approved for the treatment of serious infections caused by resistant gram-negative bacteria. This article reviews the spectrum of activity, clinical pharmacology, pharmacodynamic and pharmacokinetic properties, clinical efficacy and tolerability, and dosing and administration of ceftazidime-avibactam.
Beyond Vancomycin: The Tail of the LipoglycopeptidesThe purpose of this comparative review is to provide clinical information on the semisynthetic lipoglycopeptides (telavancin, oritavancin, and dalbavancin) for the management of gram-positive infections.
Review of the Persistence of Herpes Zoster Vaccine Efficacy in Clinical TrialsThe live attenuated herpes zoster vaccine* was approved for the prevention of shingles in 2006. Initial Phase III clinical trials proved vaccine efficacy persisted during the study duration; however, assessment of long-term efficacy required additional studies. This article reviews efficacy data for the zoster vaccine that have been published since 2004. It focuses on studies assessing declining vaccine efficacy.
Nonstatin Therapies for Management of Dyslipidemia: A ReviewCardiovascular disease (CVD) is the leading cause of morbidity and mortality in the United States. Recently published cholesterol treatment guidelines emphasize the use of statins as the preferred treatment strategy for both primary and secondary prevention of CVD. However, the optimal treatment strategy for patients who cannot tolerate statin therapy or those who need additional lipid-lowering therapy is unclear in light of recent evidence that demonstrates a lack of improved cardiovascular outcomes with combination therapy.
Cobicistat: Review of a Pharmacokinetic Enhancer for HIV InfectionThis article reviews the clinical pharmacology, pharmacodynamic and pharmacokinetic (PK) properties, clinical efficacy and tolerability, drug interactions, and dosing and administration of cobicistat.
Current Practices in the Treatment of Alzheimer Disease: Where is the Evidence After the Phase III Trials?The purpose of this systematic review was to review the current place in therapy of the 4 medications, donepezil, rivastigmine, galantamine, and memantine, approved for the treatment of Alzheimer disease (AD) since the publication of Phase III trials.
The Role of Sodium-Glucose Co-Transporter 2 Inhibitors in the Treatment of Type 2 DiabetesDiabetes is a chronic metabolic disorder characterized by hyperglycemia that results from insulin resistance, diminished or absent insulin secretion, or both. Approximately one-half of patients with diabetes fail to achieve acceptable glycemic control. Consequently, morbidity and mortality associated with diabetes is high, resulting from complications such as cardiovascular disease and nephropathy. The sodium-glucose co-transporter 2 (SGLT2) inhibitors are a new class of medications for the treatment of type 2 diabetes.
New FDA-Approved Disease-Modifying Therapies for Multiple SclerosisInterferon injectables and glatiramer acetate have served as the primary disease-modifying treatments for multiple sclerosis (MS) since their introduction in the 1990s and are first-line treatments for relapsing-remitting forms of MS (RRMS). Many new drug therapies were launched since early 2010, expanding the drug treatment options considerably in a disease state that once had a limited treatment portfolio. The purpose of this review is to critically evaluate the safety profile and efficacy data of disease-modifying agents for MS approved by the US Food and Drug Administration (FDA) from 2010 to the present and provide cost and available pharmacoeconomic data about each new treatment.
Emerging New Therapies for the Treatment of Type 2 Diabetes Mellitus: Glucagon-like Peptide-1 Receptor AgonistsThe goal of this article was to review the safety, efficacy, and potential for utilization of the newly approved once-weekly glucagon-like peptide-1 (GLP-1) receptor agonists in the treatment of type 2 diabetes.
Rivaroxaban: An Oral Factor Xa InhibitorCurrently available anticoagulants utilized for venous thromboembolism (VTE) treatment and prevention and stroke prevention in patients with atrial fibrillation (AF) have proven effectiveness but are not optimally utilized because of barriers such as the need for subcutaneous administration and requisite routine laboratory monitoring. Rivaroxaban, a novel oral Xa inhibitor, is an alternative to standard therapies utilized for VTE prevention after elective orthopedic surgery, primary and secondary stroke prevention in nonvalvular AF, VTE treatment after an acute VTE event, and secondary prevention after the acute coronary syndromes (ACS).
Clinical Overview of Dalfampridine: An Agent With a Novel Mechanism of Action to Help With Gait DisturbancesMedication used to treat multiple sclerosis (MS) can be categorized as disease-modifying therapies, symptomatic therapies, or treatment of acute exacerbations. Dalfampridine is the first symptomatic therapy approved by the Food and Drug Administration to improve walking in patients with MS.
Vismodegib and the Hedgehog Pathway: A New Treatment for Basal Cell CarcinomaVismodegib is an oral inhibitor of the Hedgehog pathway approved by the US Food and Drug Administration. It is the first systemic treatment for patients with locally advanced or metastatic basal cell carcinoma that is not amenable to surgery and radiation. This is the first drug to use the Hedgehog pathway to inhibit the proliferation of tumors and is also implicated in the development of other cancers such as medulloblastoma.
Boceprevir: A Protease Inhibitor for the Treatment of Hepatitis CBoceprevir is a protease inhibitor indicated for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection in combination with peginterferon and ribavirin for treatment-naive patients and those who previously failed to improve with interferon and ribavirin treatment.
Telaprevir: A Hepatitis C NS3/4A Protease InhibitorTelaprevir is a hepatitis C NS3/4A protease inhibitor approved by the US Food and Drug Administration as part of combination therapy for the management of chronic hepatitis C virus (HCV) genotype 1 infection.
Ezogabine (Retigabine) and Its Role in the Treatment of Partial-Onset Seizures: A ReviewEzogabine, also known as retigabine, is a recently approved anticonvulsant medication with a novel mechanism of action. It activates low-threshold voltage-gated potassium channels, leading to hyperpolarization of the membrane potential, stabilization of the resting membrane potential, and suppression of repetitive firing.
Tetrabenazine for the Treatment of Hyperkinetic Movement Disorders: A Review of the LiteratureTetrabenazine (TBZ) is a monoamine storage inhibitor that was first introduced in the 1970s for the management of hyperkinetic movement disorders. Despite acceptance and usage worldwide, TBZ was only recently approved in the United States for the treatment of Huntington chorea. This review focuses on the use of TBZ in various hyperkinetic movement disorders, which are considered “rare” or “orphan” diseases, to help practitioners better understand its clinical role and use.
Vemurafenib in Patients With BRAF V600E Mutation–Positive Advanced MelanomaVemurafenib is an oral, small-molecule kinase inhibitor that selectively targets activated BRAF V600E and has been approved for the treatment of advanced BRAF mutation–positive melanoma.
Eribulin Mesylate (E7389): Review of Efficacy and Tolerability in Breast, Pancreatic, Head and Neck, and Non–Small Cell Lung CancerEribulin mesylate is a halichondrin B analogue that acts as a nontaxane microtubule dynamics inhibitor. Eribulin was approved in the United States in 2010 for the treatment of metastatic breast cancer for patients who have received at least 2 metastatic breast cancer chemotherapeutic regimens, including an anthracycline and a taxane. Eribulin is administered as a single agent at 1.4 mg/m2 IV for 2 to 5 minutes on days 1 and 8 of a 21-day cycle.
Ticagrelor: Oral Reversible P2Y12 Receptor Antagonist for the Management of Acute Coronary SyndromesThe clinical benefits of dual antiplatelet treatment (aspirin + clopidogrel) in the management of acute coronary syndromes (ACS) are well established. However, clopidogrel is a prodrug that requires hepatic activation. Concerns regarding its delayed onset of action, variability in antiplatelet effects, and prolonged recovery of platelet function after discontinuation have prompted the development of P2Y12 receptor antagonists. Ticagrelor is the most recently developed P2Y12 receptor antagonist available in the United States.
Asenapine: A Clinical Review of a Second-Generation AntipsychoticSchizophrenia and bipolar disorder are both prevalent types of psychiatric illness in the United States. As second-generation antipsychotics have become a more viable first-line treatment option, their use has been associated with a new era of adverse events (AEs), most notably metabolic and cardiovascular concerns. Although treatment options for schizophrenia and bipolar disorder have arguably improved, there continues to be a need for medications that achieve and maintain desired efficacy with minimal AEs.