APhA “Perennial Favorite” New Drug Review Covers 15 FDA Approvals

Unlike the previous new drug, molnupiravir is not a first-line choice. Instead, Hussar noted, it’s an option for patients “for whom alternative COVID-19 treatment options authorized by the FDA are not accessible.” And unlike nirmatrelvir/ritonavir, the efficacy of molnupiravir as determined in clinical trials is closer to 30%.

Despite that, Hussar cited a recent commentary in which authors found a similar number of prescriptions written for nirmatrelvir/ritonavir and molnupiravir. “The explanation is that molnupiravir has had wider distribution and availability than Paxlovid has had to this point in time,” Hussar said. “Supply issues are going to be a factor in distribution [of these drugs]…Distirbution is getting broader, but initially, the government was only working with the large chain pharmacies to get these [treatments] into those pharmacies.”

What Is It? Molnupiravir is a nucleoside analogue that inhibits replication of the SARS-CoV-2 virus by viral mutagenesis, available under an EUA for the treatment of mild to moderate COVID-19 in adults who have test positive for SARS-CoV-2 and are at high risk of progressing to severe COVID-19, including hospitalization and death, and for whom alternative, FDA-approved COVID-19 treatment options are either inaccessible or clinically inappropriate.

Comparable Drugs: Nirmatrelvir/ritonavir (Paxlovid)

Advantages: Molnupiravir may be effective in patients who are unable to access other available treatments, or who are not appropriate candidates for other treatments. It is not likely to interact with other medications and may be used in patients with severe hepatic or renal impairment.

Disadvantages: Based on results of noncomparative studies of the individual agents, molnupiravir may be less effective; its authorized use is more limited, and should be reserved for those without other treatment options. It also lacks authorization in pediatric populations as it may adversely impact bone and cartilage growth.

Limitations: Molnupiravir is not authorized for use in patients requiring hospitalization due to COVID-19, for pre-exposure or post-exposure prophylaxis for COVID-19 prevention, for use over a period longer than 5 consecutive days, or for use in those younger than 18 years.

Recommended Dosing and Availability: 800 mg (4 capsules) every 12 hours for 5 days. It is available as 200 mg capsules

Risks, Contraindications, and AEs: Molnupiravir may cause adverse developmental effects and, as such, should not be used during pregnancy. Common adverse events include diarrhea, nausea, and dizziness

Hussar’s New Drug Comparison Rating: 2. There are significant disadvantages with respect to use, effectiveness, safety, and/or administration.

“Atogepant is part of a growing group of gepant drugs for migraine,” said Hussar. Over the last few years, a number of calcitonin gene-related peptide (CGRP) products have been brought to market, capitalizing on the naturally its naturally occurring vasodilating effects.

In studies of patients with migraine, researchers have found that there are higher concentrations CGRP, said Hussar, “prompting pharmaceutical companies to start evaluating antagonists of this CGRP protein.”

In 2018, 3 injectable monoclonal antibodies were approved for the preventive treatment of chronic migraine: erenumab (Aimovig), gremanezumab (Ajovy), and galcanezumab (Emgality); eptinezumab-jjmr (Vyepti) was approved in 2020. Small-molecule CGRP antagnoists came later and include rimegepant (Nurtec ODT) and ubrogepant (Ubrelvy). These drugs join triptans—all generic, Hussar pointed out—while CGRP antagonists tend to be more “high-dollar drugs.”

What Is It? A calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of episodic migraine in adults with between 4 and 14 moonthly migraine days.

Comparable Drugs: Rimegepant (Nurtec ODT); ubrogepant (Ubrelvy)

Advantages: Atogepant is less likely than rimegepant to cause hypersensitivity reactions. It may also be used at an adjusted dosage with interacting medications.

Disadvantages: The labeled indications of atogepant are more limited than rimegepant, which can also be used for acute migraine treatment.

Recommended Dosing and Availability: 10 mg, 30 mg or 60 mg once daily. Atogepant is available in 10 mg, 30 mg, or 60 mg tablets

Risks, Contraindications, and AEs: Atogepant is contraindicated for use in pregnancy and those with hepatic or renal impairment. Concurrent use of strong CYP3A4 inhibitors may increase atogepant activitiy, while strong and moderate CYP3A4 inducers may decrease atogepant activitiy. Common adverse events include nausea, constipation, fatigue, and somnolence

Hussar’s New Drug Comparison Rating: 3. There are no or minor advantages and/or disadvantages.

Hussar considers ADHD an “intriguing condition,” primarily because stimulants, the treatment of choice, seem counterintuitive. “When you think [about it], the last medications you’d be considering for a condition characterized by hyperactivity would be a stimulant.”

Viloxazine hydrochloride is an extended-release selective norepinephrine reuptake inhibitor (SNRI) for children between 6 and 17 years of age. “I’ve seen some promotions suggesting this is a first of its kind ADHD treatment,” said Hussar, noting that the extended-release formula means that patients won’t need to bring controlled substances to school with them to dose throughout the day. But like other brand-name ADHD drugs, “It’s not inexpensive,” said Hussar, “[at] $300 for a 30-day supply.”

What Is It? A selective norepinephrine reuptake inhibitor for the treatment of ADHD in chdilren between 6 and 17 years of age.

Comparable Drugs: Atomoxetine (Strattera)

Advantages: Viloxazine hydrochloride has few contraindications and warnings, which include conditions—like narrow-angle glaucoma and severe cardiovascular disorders—that are typically seen in adults.

Disadvantages: This treatment is not indicated for use in adults with ADHD. It is a strong CYP1A2 inhibitor, and use with sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range is contraindicated.

Recommended Dosing and Availability: For children ages 6 to 100, begin with 100 mg once daily, titrating in increments of 100 mg on a weekly basis to the maximum recommended dose of 400 mg once daily. For children ages 12 to 17, begin with 200 mg once daily. After 1 week, the dose may be increased to 400 mg once daily. The product is available in 100 mg, 150 mg, and 200 mg extended-release capsules.

Risks, Contraindications, and AEs: Viloxazine hydrochloride has a boxed warning for suicidal thoughts and behaviors; the drug may also activate mania or hypomania, and patients should be screened for bipolar disorder prior to initiating treatment. Interactions with MAOIs have been noted, as well as interactions with sensitive CYP1A2 substrates, CYP1A2 sustrates with narrow therapeutic range, CYP2D6 substrates, and CYP3A4 substrates. Common adverse events include somnolence, headache, fatigue, decreased appetite, nausea, vomiting, insomnia, and irritability

Hussar’s New Drug Comparison Rating: 2. There are significant disadvantages with respect to use, effectiveness, safety, and/or administration

Unlike viloxazine hydrochloride, the second newly approved ADHD medication from 2021 does fall under the category of stimulant, meaning that serdexmethylphenidate/dexmethylphenidate HCl is a Schedule II drug. The drug, Hussar added, also utilizes complex dosing and potency options, which may be a barrier to use.

What Is It? A central nervous system stimulant for the treatment of ADHD in patients age 6 or older.

Comparable Drugs: dexmethylphenidate (Focalin XR)

Advantages: None

Disadvantages: The dosing and formulation potencies are complex.

Recommended Dosing: In patients between 6 and 12 years of age: begin with 39.2 mg/7.8 mg once daily. After 1 week, this may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily. In patients age 13 and oder, begin with 39.2 mg/7.8 mg once daily. After 1 week, this may be increased to 52.3 mg/10.4 mg per day. This drug is available in 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, 52.3 mg/10.4 mg capsules. The molar dose of these 2 agents combined is equivalent to 20 mg, 30 mg, or 40 mg of dexmethylphenidate hydrochloride, respectively.

Risks, Contraindications, and AEs: Due to the inclusion of dexmethylphenidate, there is a risk for abuse and dependence. There may also be a risk of cardiovascular reactions, increases in blood pressure and heart rate, psychotic or manic symptoms, peripheral vasculopathy, and long-term suppression of growth. This drug interacts with MAOI inhibitors, antihypertensive drugs, risperidone, and halogenated anesthetics. Common adverse events include decreased appetite and weight, nausea, abdominal pain, vomiting, dyspepsia, insomnia, anxiety, irritability, dizziness, increased blood pressure, and tachycardia.

Hussar’s New Drug Comparison Rating: 3. There are no or minor advantages and/or disadvantages.

“We could spend the whole 2 hours and more discussing the next drug,” said Hussar of Biogen’s aducanumab-avwa, approved in 2021 under the FDA’s accelerated approval pathway. Nearly 6 million Americans are living with Alzheimer disease, but what should have perhaps been a celebratory moment for these patients—as well as their friends, families, and caregivers—was, in reality, incredibly controversial.

“In clinical trials, this drug has been reported to reduce amyloid beta lesions in the brain…That reduction, in and of itself, does not benefit clinical benefit,” Hussar said. Biogen, he added, implemented 2 “essentially identical studies” where researchers evaluated concentration of amyloid beta, the extent of accumulation via brain MRIs, and the clinical benefit. Results of a futility analysis found that although amyloid beta was reduced, “it doesn’t look like the product is effective in improving cognition [or] improving memory. [Biogen] terminated both studies before the panned date.”

Members of the FDA Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted against recommending the drug for approval. Despite that, the FDA approved the drug—initially slated to cost $56,000 for a 1-year supply—in June 2021 on the condition that Biogen conduct a new randomized controlled trial to confirm aducanumab-avwa’s benefit. By December 2021, the cost was cut by 50% to $28,000. Additional controversy has stemmed from a recent CMS proposal to cover this drug only for patients who are taking part in randomized clinical trials.

“There have been few other FDA approvals that are as controversial as this one has been,” said Hussar. “The approval was premature before clinical benefit was demonstrated…I think this is a public disservice; hopes are raised. Other companies that have monoclonal antibodies that have been thought to be a benefit for Alzheimer [disease], they’re saying ‘Biogen could get approval, we can too.'”

What Is It? A amyloid beta-directed antibody for the treatment of patients with Alzheimer disease. The indication was revised to indicate that treatment with aducanumab-avwa should be initiated in patients with mild cognitive impairment or in the mild dementia stage of the disease.

Comparable Drugs: cholinesterase inhibitors (donepezil) and memantine (Namenda)

Advantages: Aducanumab-avwa has a unique mechanism of action, reducing amyloid beta plaques in the brain.

Disadvantages: The clinical benefit of aducanumab-awva has not yet been established. In contrast to comparable drugs, this treatment must be administered intravenously and requires brain MRI monitoring. It may cause amyloid-related imaging abnormalities (ARIA) and has not been directly compared with similar drugs in rigorous clinical trials.

Recommended Dosing and Availability: Intravenous infusion over a 1-hour period every 4 weeks (at least 21 days apart). The initial dosage for the first 2 infusions is 1 mg/kg, increased to 3 mg/kg for infusions 3 and 4, to 6 mg/kg for infusions 5 and 6, and to 10 mg/kg for infusion 7 and beyond. Brain imaging should be completed before starting treatment and before infusions 7 and 12. Aducanumab-avwa Single-dose vials of 170 mg/1.7 mL and 300 mg/3 mL that should be refrigerated. The solution, with the appropriate dose/volume should be added to an infusion bag of 100 mL of 0.9% sodium chloride injection and administered immediately using an intravenous line containing sterile low-protein binding and a 0.2 or 0.22 micron in-line filter.

Risks, Contraindications, and AEs: ARIA are common, including edema, hemosiderin deposition and hemosiderin deposition. During the first 8 doses, enhanced clinical vigilance is recommended. Common adverse events include ARIA-edema, ARIA-H microhemorrhage, ARIA-H superficial siderosis, headache, and falls

Hussar’s New Drug Comparison Rating: 1. There are important disadvantages.

Multiple sclerosis affects about 400,000 Americans, most of whom are women. Because symptoms typically begin their onset between ages 20 and 40—a woman’s childbearing years—“one parameter of [MS drugs] that we are interested in is safety during pregnancy.”

For years, Hussar said, there were no drugs available for MS; then, interferon beta became the first disease-modifying therapy available to treat the disease. Although ponesimod represents a new treatment option as a sphingosone 1-pohsphate receptor 1 modulator, there are numerous potential disadvantages, including serious cardiovascular complications and contraindications.

What Is It? A sphingosine 1-phosphate (S1P) receptor modulator for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults.

Comparable Drugs: Ozanimod (Zeposia); fingolimod (Gilenya); siponimod (Mayzent)

Advantages: In comparative studies, ponesimod has demonstrated better effectiveness than teriflunomide (Aubagio); it binds closely to S1P receptor 1. When treatment is discontinued, lymphocyte counts begin to return to normal more quickly, and the drug may interact with fewer medications.

Disadvantages: After receiving the first dose, patient monitoring is recommended for 4 hours in those with certain preexisting heart conditions, including sinus bradycardia, first- or second-degree AV block (Mobitz type 1), or a history of myocardial infarction or heart failure more than 6 months before treatment initiation. The labeled indications are more limited, and dosage titration is more complex.

Recommended Dosing and Availability: For the first 2 days, take 2 mg once daily. After, titrate according to the product labeling instructions to a dose of 20 mg once daily by day 15 and thereafter. Before starting treatment, patients must have a complete blood count, cardiac evaluation, liver function tests, ophthalmic evaluation, and a review of current and prior medications with immune system effects and vaccinations. Treatment should be reinitiated if patients miss 4 or more consecutive doses during either titration or maintenance. Ponesimoid is available in 2 mg, 3 mg, 4 mg, 4 mg, 6 mg, 7 mg, 8 mg, 10 mg, and 20 mg film-coated tablets. A starter pack for titration and maintenance dose (20 mg) are available.

Risks, Contraindications, and AEs: Ponesimod is contraindicated in those who have experienced myocardial infarction, unstable angina, stroke, or transient ischemic attack in the last 6 months, or who have had decompensated heart failure requiring hospitalization or Class III/IV heart failure during the same time period. It is also contraindicated in those with Mobitz type II second- or third-degree AV block or sick sinus syndrome, except for patients who have a functioning pacemaker. Additional contraindications include bradyarrhythmia and AV conduction delays, infections, liver injury, macular edema, and cutaneous malignancies. Interactions include QT-prolonging drugs, antiarrhythmic drugs, drugs that decrease heart rate, and strong CYP3A4 and UGT1A1 inducers. Common adverse events include upper respiratory infection and transaminase elevations

Hussar’s New Drug Comparison Rating: 2. There are significant disadvantages with respect to use, effectiveness, safety, and/or administration.

“Lupus is another condition that primary affects women,” said Hussar. “Typiaclly, it starts out with some joint arthralgias, arthritis, [or] dermatologic effects, but there can be renal and cardiac implications [as well].”

Anifrolumab-fnia has, Hussar noted, a few disadvantages—including the intravenous administration and limited approved indications—but “there aren’t many options to begin with for the treatment of lupus. It has a unique mechanism of action and may be of value in individuals who have not achieved adequate benefit.”

What Is It? A type 1 interferon receptor antagonist for the treatment of adults with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy.

Comparable Drugs: Belimumab (Benlysta)

Advantages: Anifrolumab-fnia has a unique mechanism of action; it is the first type I interferon receptor antagonist, and it may be less likely to cause serious adverse events.

Disadvantages: The drug is administered intravenously, compared with belimumab administration which is subcutaneous or intravenous. Anifrolumab-fnia is indicated for use in adults only, and labeled indications are more limited—it cannot be used to treat patients with active lupus nephritis.

Recommended Dosing and Availability: 300 mg every 4 weeks as an intravenous infusion administered over a 30-minute period. For injection, anifrolumab-fnia is available as single-dose vials of 300 mg/2 mL that should be refrigerated and must be diluted by adding to a 100 mL 0.9% Sodium Chloride Injection infusion bag.

Risks, Contraindications, and AEs: Risks include serious infections, hypersensitivity reactions—including anaphylizis and angioedema—and malignancies. Patients receiving this therapy should not receive live or live attenuated vaccines, and the current use of other biologic therapies should be avoided. Common adverse events include upper respiratory tract infection, bronchitis, infusion-related reactions, herpes zoster, cough, and hypersensitivity.

Hussar’s New Drug Comparison Rating: 4. There are significant advantages with respect to use, effectiveness, safety, and/or administration.

There are roughly 6 million Americans with heart failure (HF), said Hussar, and approximately 50% of those have HF with reduced ejection fraction (HFrEF), characteristic of chronic heart failure. “It’s estimated that 50% of those with worsening chronic HF are hospitalized within 30 days of an event,” Hussar added.

Typically, people with HF are treated with an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)—all of which are available as a generic, meaning that HF treatment has become “relatively inexpensive, even with [only] 4 or 5 drugs being used.” Recent revisions to HF treatment guidelines list sacubitril/valsartan (Entresto) as the preferred drug to either an ACE inhibitor or ARB. Like sacubitril/valsartan, vericiguat (Verquvo) is available only as a brand-name medication, increasing the expense associated with HF treatment.

What Is It? A soluble guanylate cyclase (sGC) stimulator to reduce the risk of death and heart failure (HF) hospitalization following a hospitalization for HF, or the need for outpatient intravenous diuretics, in adults with symptomatic chronic HF and an ejection fraction less than 45%.

Comparable Drugs: Ricoiguat (Adempas)

Advantages: The clinical benefit of vericiguat has been demonstrated in those with HF. It may also provide benefits to those with inadequately managed HF after trying the preferred drugs for initial HF management.

Disadvantages: The clinical benefit of vericiguat is limited.

Recommended Dosing and Availability: To start, the initial dose of vericiguat is 2.5 mg once daily with food. The dose will be doubled every 2 weeks in order to reach a target maintenance dose of 10 mg once daily with food. Vericiguat is available in 2.5 mg, 5 mg, and 10 mg film-coated tablets

Risks, Contraindications, and AEs: Vericiguat therapy is contraindicated in pregnancy and those who are lactating or who have hepatic impairment. Concurrent use is contraindicated with other sGC stimulators and phosphodiesterase-5 inhibitors. Common adverse events include hypotension and anemia

Hussar’s New Drug Comparison Rating: 4. There are significant advantages with respect to use, effectiveness, safety, and/or administration.

In recent years, the value of drugs like spironolactone and finerenone (Kerinda) has been recognized in the treatment of those living with heart failure, said Hussar. For those living with chronic kidney disease as a result of type 2 diabetes, finerenone is a good option for some patients—“a better choice with lesser risk than spironolactone and a lot of the other predecessors,” Hussar explained—to prevent a range of conditions including end-stage kidney disease, nonfatal myocardial infarction, hospitalization for heart failure, and cardiovascular death.

What Is It? A nonsteroidal mineralocorticoid receptor (MR) antagonist to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure associated with type 2 diabetes.

Comparable Drugs: eplerenone (Inspra), spironolactone

Advantages: Finerenone is the first FDA-approved nonsteroidal MR antagonist; it has a higher sensitivity for the MR and is effective in reducing the risks associated with chronic kidney disease in diabetes. It may also be less likely than other available options to cause hyperkalemia and is less likely to cause endocrine events than spironolactone.

Disadvantages: Finerenone has fewer labeled indications than comparable drugs.

Recommended Dosing and Availability: For patients with an eGFR of 25 to less than 60, initial does is 10 mg daily for 4 weeks. For patients with an eGFR greater than 60, initial dose is 20 mg daily for 4 weeks. After 4 weeks, the dose may be increased to the target maintenance dose of 20 mg once daily. Prescribers should evaluate both serum potassium concentrations and eGFR before initiation of therapy; those with serum potassium greater than 5.0 mEq/L should not begin therapy. Finerenone is available in 10 mg or 20 mg film-coated tablets.

Risks, Contraindications, and AEs: Use of finerenone is contraindicated in those with adrenal insufficiency, hyperkalemia, and hepatic impairment, as well as in those who are lactating. This drug has interactions with strong CYP3A4 inhibitors, strong or moderate CYP3A4 inducers, and grapefruit or grapefruit juice. Common adverse events include hyperkalemia and hypotension

Hussar’s New Drug Comparison Rating: 4. There are significant advantages with respect to use, effectiveness, safety, and/or administration.

Estetrol monohydrate/drospirenone (Nextellis) contains the first new estrogen product available in the United States in 50 years. But that doesn’t particularly impress Hussar: “Whenever I hear a promotion for new products saying, ‘first in 10 years,’ 20 years, 50 years, my thought process is, ‘If that’s the best they can say, do we need to look further?’”

Estetrol a synthetic version of estrogen that naturally occurs in the body, with a longer half-life than other estrogens that are available. “Theoretically—it hasn’t been compared—but theoretically, it could reduce the risk of unscheduled bleeding,” Hussar noted.

The product comes with a significant caveat, though—it may not be as effective in women with a BMI greater than 30 kg/m².

What Is It? A combination oral estrogen/progestin contraceptive for use of women of reproductive potential to prevent pregnancy.

Comparable Drugs: Other available oral estrogen/progestin contraceptive products.

Advantages: Estetrol has a longer half-life and is selective for alpha and beta nuclear estrogen receptors. It may also have less of a risk compared with other estrogens, but comparative studies have not been done.

Disadvantages: Estetrol monohydrate/drospirenone may be less effective in women with a BMI of 30 kg/m² or higher.

Recommended Dosing and Availability: One tablet daily, taken at the same time each day. This product is available in 14.2 mg estetrol (15 mg estetrol monohydrate) and 3 mg drospirenone tablets in blister packs containing 28 tables (24 active and 4 inert tablets)

Risks, Contraindications, and AEs: This product contains a boxed warning for women who are older than 35 and who smoke, as smoking increases the risk of serious cardiovascular events. Use is contraindicated in women with a high risk of thromboembolic disease, current or previous hormonally sensitive malignancy, thromboembolic or other vascular disorders, migraine, liver disease, gallbladder disease, bleeding irregularities and amenorrhea, and glucose tolerance and hypertriglyceridemia. Concurrent use with ombitasiver/paritaprevir/ritonavir is contraindicated; contraindications are also found with CYP3A inducers, lamotrigine, and systematic corticosteroids. Common adverse events include mood disturbance, bleeding irregularities, breast symptoms, headache, dysmenorrhea, weight gain, and acne

Hussar’s New Drug Comparison Rating: 3. There are no or minor advantages and/or disadvantages.

Ibrexafungerp citrate (Brexafemme) is the “first modern oral treatment” designed to eliminate the yeast causing a vulvovaginal candidiasis infection. Previous treatments, Hussar noted, included options like vaginal administration of an antifungal agent like miconazole, or a single oral fluconazole dose.

“There is some evidence that an increasing number of strains of Candida albicans are not responding adequately to fluconazole, but that hasn’t reached the point where I think we need alternatives—although, I’m not ignoring the potential benefit,” said Hussar, noting that these benefits may include effective treatment against other species of Candida.

What Is It? A triterpenoid antifungal agent for the treatment of adult and post-menarchal pediatric girls with vulvovaginal candidiasis.

Comparable Drugs: Fluconazole (Diflucan)

Advantages: Ibrexafungerp citrate may be effective against infections caused by Candida strains that are fluconazole resistant. This drug has a unique mechanism of action that inhibits glucan synthase and exhibits fungicidal activity.

Disadvantages: This medication is contraindicated in woman who are pregnant and may cause gastrointestinal adverse events. It has not been directly compared with flucanizole in clinical research, and the lable indications are more limited.

Recommended Dosing and Availability: 300 mg (2 tablets) twice daily for 1 day. Medication dose should be reduced to 150 mg twice daily for 1 day in patients also taking a strong CYP3A4 inhibitor. Ibrexafungerp citrate is available 150 mg tablets in a blister pack with 4 tablets.

Risks, Contraindications, and AEs: This drug is contraindicated in pregnancy. Ibrexafungerp citrate has noted interactions with strong CYP3A4 inhibitors and strong or moderate CYP3A4 inducers. Commona adverse events include diarrhea, nausea, and abdominal pain.

Hussar’s New Drug Comparison Rating: 3. There are no or minor advantages and/or disadvantages.

Many older adults experience overactive bladder. “The agents that would usually be employed first would be anticholinergic drugs,” Hussar said, adding that many of these drugs are generic and are, therefore, available at a low cost. However, these anticholinergic agents may contribute to cognitive issues—including worsening—in older adults, creating a need for alternative therapies that would be better tolderated.

Vibegron (Gemtesa) is one of these options, but it’s expensive: $500 for a 30-day supply. “As long as an anticholinergic medication doesn’t present excessive risk, they are much less expensive.”

What Is It? A beta-3 adrenergic receptor agonist for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

Comparable Drugs: Mirabegron (Mybetriq)

Advantages: Vibegron is less likely to increase blood pressure and not likely to interact with CYP2D6 substrates.

Disadvantages: The labeled indications for vibegron are more limited compared with mirabegron.

Recommended Dosing and Availability: 75 mg once daily with or without food. The treatment is available in 75 mg tablets.

Risks, Contraindications, and AEs: The risk of urinary retention is increased in patients with bladder outlet obstruction and those taking a muscarinic antagonist. This medication should not be used in those with hepatic or renal impairment. During use, digoxin concentration and exposure may be increased, so levels should be monitored. Common adverse events include headache, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection

Hussar’s New Drug Comparison Rating: 4. There are significant advantages with respect to use, effectiveness, safety, and/or administration.

Acne is, according to Hussar, the most common dermatologic problem. “It can be estimated that at any given time, there are 50 million Americans who have acne of some degree of severity,” he noted. Despite how common acne is, clascoterone (Winlevi) has been described as “the first truly new mechanism of action in acne in nearly 40 years.”

What Is It? A topical androgen receptor inhibitor for the treatment of acne vulgaris in patients 12 years and older.

Comparable Drugs: Topical retinoids. For this comparison, adapalene (Differin) is used.

Advantages: Clascoterone, a topical androgen receptor inhibitor, has a unique mechanism of action.

Disadvantages: This trug may cause hyperkalemia and hypothalamic-pituitary-adrenal axis suppression. It requires twice-daily administration and a prescription, and formulation options are more limited. It has not be directly compared with similar drugs in clinical research.

Recommended Dosing and Availability: Approximately 1 g applied topically in a thin layer twice a day (morning and evening). Clascoterone is available in a 1% cream that should be refrigerated prior to dispensing

Risks, Contraindications, and AEs: Local skin reactions may occur. Patients should avoid concomitant use with other topical products that are potentially irritating. Common adverse events include erythema/redness, scaling/dryness, and pruritus

Hussar’s New Drug Comparison Rating: 2. There are significant disadvantages with respect to use, effectiveness, safety, and/or administration.

Actinic keratosis is the second most common diagnosis made by dermatologists, said Hussar. These lesions—sometimes referred to as age spots or sunspots—are common in older, lighter skinned people who have had extended exposure to sunlight throughout their life. Most lesions are innocuous, Hussar noted, but there may be a greater risk of squamous cell carcinoma in those who have actinic keratosis.
What Is It? A microtubule inhibitor for the treatment of actinic keratosis of the face or scalp.

Comparable Drugs: Topical fluorouracil (Fluoroplex)

Advantages: Tirbanibulin has a unique mechanisum of action and a shorter duration of treatment, at 5 days vs 2 to 6 weeks. It is applied once daily and is less likely to cause severe dermatologic adverse events. This product may also be cautiously used during pregnancy.

Disadvantages: The labled indications of tirbanibulin are more limited.

Recommended Dosing and Availability: Patients should apply a sufficient amount to evenly cover up to 25 cm2 on the face or scalp, once daily for 5 consecutive days. Tirbanibulin is available in a 1% ointment in single-dose packets.

Risks, Contraindications, and AEs: This product may cause severe skin reactions, including postulation, erosion, or ulceration. It should not be used after drug or surgical treatments until skin is completely healed. Local skin reactions including erythema, flaking/scaling, crusting, swelling, erosion/ulceration, application site pain, and application site pruritus

Hussar’s New Drug Comparison Rating: 4. There are significant advantages with respect to use, effectiveness, safety, and/or administration.