AbbVie’s Vraylar Gets Expanded Approval for Major Depressive Disorder

AbbVie’s Vraylar, an atypical antipsychotic medication, has been granted expanded approval by the US Food and Drug Administration (FDA) to treat adults with Major Depressive Disorder (MDD). This development offers a promising new treatment option for individuals struggling with depression, a pervasive and life-altering condition. In this blog post, we will highlight the key points surrounding Vraylar’s recent approval for MDD, and discuss its significance for patients and healthcare professionals.

Key Points

Here are the key points to know about the expanded approval of Vraylar for Major Depressive Disorder:

1. Major Depressive Disorder:

Major Depressive Disorder, or clinical depression, affects millions of people worldwide. It is a debilitating mental health condition characterized by persistent feelings of sadness, hopelessness, and disinterest in activities. Traditional antidepressant medications have been the primary treatment option for MDD, but these have been known to have limitations, such as delayed onset of action or inadequate therapeutic response.

2. Atypical Antipsychotic Medication:

Vraylar is an atypical antipsychotic medication that works by modulating dopamine and serotonin activity in the brain. It was originally approved by the FDA in 2015 for the treatment of schizophrenia and in 2017, it was also granted approval for manic or mixed episodes associated with Bipolar I Disorder.

3. Expanded Approval:

The recent expanded approval of Vraylar marks a significant milestone in the treatment of MDD. This development demonstrates the potential for atypical antipsychotic medications to become a viable option for individuals with MDD who have not responded adequately to traditional antidepressant medications.

4. Clinical Trials:

To obtain FDA approval for the expanded indication of MDD, AbbVie conducted well-designed clinical trials to establish the safety and efficacy of Vraylar in MDD patients. The data from these studies showed significantly greater improvement in depression symptoms compared to a placebo.

5. Unique Mechanism of Action:

Unlike traditional antidepressants which primarily affect serotonin, Vraylar’s unique mechanism of action may offer distinct advantages in treating MDD. By modulating both dopamine and serotonin activity in the brain, it offers the potential for a more comprehensive response to depression symptoms.

6. Potential Side Effects:

Like all medications, Vraylar has possible side effects that need to be considered for each individual patient. Common Vraylar side effects include insomnia, sedation, movement disorders and more. An individual must speak with their healthcare professional to understand the potential risks and benefits of Vraylar.

7. Expanded Treatment Options:

The expanded approval for Vraylar is significant for patients with MDD. With this added treatment option, individuals who have not responded to traditional antidepressant medications may have a new lease on life. It may also help decrease the use of multiple medications or combinations of therapies, that impacted the safety and efficacy of those treatments.


The expanded approval for Vraylar as a treatment option for Major Depressive Disorder is a significant development in the field of mental health. This medication offers new hope for individuals with MDD who have struggled to find relief from their symptoms. With its unique mechanism of action and proven efficacy, Vraylar has the potential to become a valuable addition to currently available treatment options. As with any medication, due diligence is important to weigh the potential risks and benefits before initiating treatment. With the expanded approval of Vraylar by the FDA, individuals with MDD have more hope, and healthcare professionals have an additional tool to combat this devastating mental health condition.