Drug Discovery and Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

FDA approves cariprazine as an adjunctive treatment for major depressive disorder

By Brian Buntz | December 17, 2022

AbbVie/Gedeon RichterAbbVie (NYSE:ABBV) has announced that the FDA has approved Vryalar (cariprazine) as an adjunctive therapy to antidepressants to treat major depressive disorder (MDD) in adults.

Cariprazine is a novel atypical antipsychotic drug (APD) that works as a partial agonist at the dopamine D2 and D3 receptors and serotonin 5-HT1A receptors. It works as an antagonist at the 5-HT2B serotonin receptor.

The indication is the fourth for the drug, which first scored FDA approval as an acute schizophrenia treatment and for bipolar disorder in 2015. Two years later, the drug won an indication as a maintenance treatment for schizophrenia. In 2019, cariprazine won expanded use to treat depressive episodes related to bipolar depression in adults.

Cariprazine is the only dopamine and serotonin partial agonist to win FDA approval for MDD and the depressive episodes associated with bipolar I disorder. 

Supported by clinical data demonstrating efficacy and well-established tolerability, this additional indication provides a new option for adults who have a partial response to the treatment of an antidepressant.

In 2021, cariprazine added $1.728 billion to AbbVie’s bottom line. The company anticipates the drug will fetch peak sales of $4 billion. 

AbbVie developed cariprazine in concert with Budapest, Hungary–based Gedeon Richter Plc.

Several companies are developing alternative treatments to traditional SSRIs. Among them are Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq:BIIB), which filed a rolling NDA submission to the FDA for zuranolone, a potentially novel, rapid-acting, neuroactive steroid for MDD and postpartum depression. 

Earlier this year, Axsome Therapeutics (Nasdaq:AXSM) won FDA approval for Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets for treating MDD.

In reviewing cariprazine, FDA considered data from the Phase 3 study 3111-301-001, which found that patients receiving the drug as an adjunctive therapy to an antidepressant had a significant change from baseline to week six based on the Montgomery-Åsberg Depression Rating Scale (MADRS).

An additional study, the registration-enabling RGH-MD-75, also found a clinically and statistically significant change from baseline to week eight in the MADRS total score for patients receiving cariprazine with adjunctive antidepressant therapy. 


Filed Under: Psychiatric/psychotropic drugs
Tagged With: cariprazine
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

Related Articles Read More >

Why Cybin’s CEO sees RFK Jr. and J&J’s ketamine clinics as keys to clinical psilocybin’s mainstream moment
Muse Clinic: Innovating with Psychedelics and Neurotechnology
Can LSD break the 20-year drought in anxiety treatment?
MAPS
FDA rejection of MDMA and journal retractions jolt psychedelic therapy research
MDMA
Experts endorse MDMA-assisted therapy for PTSD amid FDA adcomm setback
“ddd
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in the drug discovery and development industry.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Drug Discovery and Development
  • MassDevice
  • DeviceTalks
  • Medtech100 Index
  • Medical Design Sourcing
  • Medical Design & Outsourcing
  • Medical Tubing + Extrusion
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Pharmaceutical Processing World

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Drug Discovery & Development

  • Home Drug Discovery and Development
  • Drug Discovery
  • Women in Pharma and Biotech
  • Oncology
  • Neurological Disease
  • Infectious Disease
  • Resources
    • Video features
    • Podcast
    • Voices
    • Views
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE