New Medications Approved in 2023: Alzheimer’s Disease, Depression, Anxiety and Schizophrenia

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This article delves into the specifics of new treatment options for these conditions: Alzheimer’s disease, depression, postpartum depression, generalized anxiety disorder in children, and schizophrenia.

Lecanemab emerges as a significant development in slowing the progression of early-stage Alzheimer’s through biweekly intravenous doses. However, it is not without concerns regarding side effects such as brain swelling.

Gepirone ER offers a new avenue for adults with depression, providing relief without some adverse effects common to SSRIs while being mindful of heart-related cautions.

Zuranolone introduces a first-of-its-kind oral therapy for postpartum depression with a rapid onset of action. Yet, its implications for breastfeeding mothers and long-term outcomes require further exploration.

Escitalopram has expanded its scope by gaining FDA approval to treat GAD in pediatric patients aged 7 years and older. This marks a meaningful extension beyond its previous approval only for adults.

A new subcutaneous formulation of risperidone simplifies the treatment regimen for adults with schizophrenia by allowing monthly or bimonthly dosing.

Alzheimer’s Disease: Lecanemab

In January 2023, the FDA approved lecanemab (Leqembi) to treat Alzheimer’s disease in mild stages.

Lecanemab requires intravenous administration every two weeks.

How does it work?

Lecanemab contains antibodies that bind to soluble amyloid-beta (Aβ) protofibrils.

Lecanemab mechanism

This image compares how the different monoclonal antibodies treat Alzheimer’s disease. Donanemab is not yet FDA-approved; clinical trials are ongoing. Source: Alzheimer’s Research UK

How effective are monoclonal antibodies in Alzheimer’s disease?

According to a recent review, FDA-approved anti-Aβ monoclonal antibodies may have a role in slowing disease progression in patients with Alzheimer’s disease, but this comes at the cost of an increased probability of side effects.

According to a recent publication, FDA-approved anti-Aβ monoclonal antibodies might help slow down the progression of Alzheimer’s disease. However, tthis comes at the cost of an increased probability of side effects.

What are the most common side effects?

Infusion-related reactions, headaches, falls, visual disturbances, dizziness, and confusion.

What is the most significant risk when using lecanemab?

It is associated with a condition known as amyloid-related imaging abnormalities, which can manifest as brain swelling and bleeding.

What is the controversy associated with lecanemab approval?

Lecanemab is made by the biopharmaceutical companies Eisai and Biogen, the same manufacturers of aducanumab, which was approved in June 2021. Learn more here.

Aducanumab’s approval was surrounded by controversy because it did not show a strong signal towards improving cognitive decline.

Patients who qualify for treatment with lecanemab exhibit mild cognitive impairment and have good functional abilities, yet they may be vulnerable to severe adverse reactions.

Depression: Gepirone ER

In September 2023, the FDA approved gepirone extended-release (Exxua)—an antidepressant that modulates serotonergic neurotransmission—for the treatment of major depressive disorder (MDD) in adults.

It’s noteworthy to mention that before this, the drug had been rejected three times, in 2004, 2007, and 2015.

Who may it be for?

Gepirone demonstrated a clear advantage over commonly used SSRIs—often linked with sexual dysfunction—by exhibiting no adverse impact on sexual function.

Who may it NOT be for?

For people at risk of QTc prolongation. In this situation, the heart muscle takes longer than usual to recharge between beats. This is important because it can cause irregular heartbeats, or "arrhythmias," and these irregular heartbeats can potentially be dangerous.

 However, patients at risk of QTc prolongation should exercise caution. Moreover, it may be advisable for the general population to undergo an electrocardiogram before starting this treatment.

Postpartum Depression: Zuranolone

On August 2023, the FDA approved zuranolone for treating postpartum depression. It is the first oral treatment option for this condition.

How does it work?

Postpartum depression is a type of depression that some women experience after giving birth.

This may be due to changes in hormone levels that affect how the brain works.

One of these hormones is called progesterone. Our bodies change progesterone into another substance called allopregnanolone. During pregnancy, the amount of allopregnanolone in the body increases, peaking in the last three months.

After the baby is born, the amount of this substance drops quickly. This drastic change can affect the brain and may contribute to postpartum depression.

Zuranolone is a medication designed to act similarly to allopregnanolone.

How fast is it?

Zuranolone may work within days. It can be used for a short-term duration of 2 weeks.

Can it be used while breastfeeding?

In current studies, mothers taking Zuranolone were not allowed to breastfeed their babies. Because of this, we don’t know how the drug might impact breastfeeding or whether it can pass into breast milk and affect the baby.

How long does the effect last?

Studies so far have only observed participants for up to 45 days, so we’re not sure how effective the drug might be in the long term.

More research is needed to understand these aspects fully.

What are the most common side effects?

The most common side effects seen in at least 10% of people taking zuranolone were drowsiness, dizziness, and sleepiness (sedation).

Generalized Anxiety Disorder in Children : Escitalopram

In August 2023, the FDA approved escitalopram (Lexapro) for the treatment of generalized anxiety disorder (GAD) in pediatric patients 7 years of age and older. Previously, escitalopram had only been approved for adult patients.

About generalized anxiety disorder

Generalized Anxiety Disorder (GAD) is a mental health condition characterized by excessive, persistent, and uncontrollable worry about everyday things.

GAD can be diagnosed when a person finds it difficult to control worry on more days than not for at least six months and has three or more symptoms, such as restlessness, fatigue, trouble concentrating, and irritability.

On-label, off-label, what does it all mean?

An "on-label"’ use is when a medication is prescribed for conditions specifically approved by the FDA.

"Off-label" use refers to prescribing medications for conditions that have not received FDA approval for that specific treatment. This is okay, as the medications have been proven effective and safe, despite not going through the FDA approval process.

For childhood generalized anxiety disorders, now the FDA has approved two medications: escitalopram and duloxetine.

Other SSRIs and SNRIs commonly used off-label include fluoxetine, fluvoxamine, sertraline, paroxetine, and venlafaxine.

Schizophrenia: A New Formulation for Risperidone

Uzedy was approved in April 2023 for the treatment of schizophrenia in adults. This subcutaneous injection is administered once every month or every two months. It is the first subcutaneous risperidone formulation.

What is a subcutaneous long-acting injectable antipsychotic?

Regular pills -oral medications- require daily intake, while long-acting antipsychotics are administered every few weeks or months. If someone struggles with taking their medication every day, a long-acting injectable may simplify their treatment schedule.

Uzedy sites of administration

What is a subcutaneous injection

What are its benefits?

This new treatment option addresses specific treatment challenges and decreases the risk of relapse. However, cost should considered, as it ranges from $1,232–$3,080 per month, depending on dosage strength.


I’d like to thank my colleague, Dr. Lorena Rodriguez, from the zPsychopharmacology Institute, who wrote the original version for clinicians.z

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