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
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE

How the antidepressant landscape evolved in 2022

By Brian Buntz | December 29, 2022

Prozac

[Image courtesy of Wikimedia Commons]

One in five people will experience major depressive disorder (MDD) at some point in their lives. Although depression is common, traditional selective serotonin reuptake inhibitors (SSRIs) such as Prozac (fluoxetine) and serotonin-norepinephrine reuptake inhibitors (SNRIs) help about 40–60% of people within six to eight weeks.

For those who don’t respond to the first treatment, however, the likelihood that a new antidepressant will help tends to go down the more therapies a patient tries.

The situation can heighten negative emotions in depressed patients. For example, about three out of ten patients with treatment-resistant depression experience feelings of frustration, hopelessness and anxiety, according to a study in BMC Psychiatry.

The antidepressant landscape, however, is diversifying. In the second half of 2022, two notable medications won FDA approval for MDD, while another could win FDA approval in 2023.

  • In August, FDA approved Auvelity from Axsome Therapeutics (Nasdaq:AXSM) for major depressive disorder. Auvelity (dextromethorphan HBr-bupropion HCl) extended-release tablets are marketed as a rapid-acting option for treating major depressive disorder (MDD) in adults. Although dextromethorphan and bupropion are widely used drugs individually, Auvelity is protected by 93 U.S. patents.
  • In December, Biogen and Sage Therapeutics filed a rolling submission for FDA approval for zuranolone for MDD and postpartum depression. Zuranolone is unique in that it is a neuroactive steroid. While Sage has commercialized another neuroactive steroid known as brexanolone for postpartum depression, it is an IV drug. If approved, Zuranolne would diversify the antidepressant landscape as it would be prescribed as a 14-day oral short-term treatment for MDD and PPD. Many patients on antidepressants take medicine daily for several months and often for multiple years.
  • In December, FDA approved Vraylar (cariprazine) as an adjunctive treatment for MDD. The drug is from AbbVie and Gedeon Richter. Cariprazine is a novel atypical antipsychotic drug (APD) that is a partial agonist at the dopamine D2 and D3 receptors and serotonin 5-HT1A receptors. It is also a 5-HT2B antagonist.

Other ways the antidepressant landscape could shift

Ketamine is gaining popularity for depression, but its potential to gain widespread traction remains unclear. Spravato (esketamine) from Johnson & Johnson won FDA approval for depression in 2019. However, the approval is limited to patients with treatment-resistant depression. In addition, patients on the drug also face logistical challenges given a program designed to manage known or potential risks associated with a drug. The program, known as Spravato REMS, requires patients taking the esketamine to be monitored in a clinical setting for at least two hours after each dose is administered.

In recent years, there has been a surge in interest in the off-label use of ketamine — generally provided as an IV infusion but sometimes subcutaneously or orally. There has been an explosion in ketamine clinics in the U.S. Programs such as Mindbloom, which offer oral ketamine via telehealth, have also gained traction.

Ketamine infusions for depression remain expensive and not typically reimbursed by insurance.

It is also possible that ketamine will face growing scrutiny in the coming months. The companies that offer it via telehealth do so based on relaxed restrictions made possible by the COVID-19 public health emergency (PHE). The federal government could let the PHE lapse in 2023, forcing online ketamine companies to change their business model. The startup Bexson Biomedical is doing preclinical studies on ketamine for mental health conditions.

In addition, several companies aim to develop psychedelics to treat depression and anxiety. Although several of these players made clinical progress in 2022, many of these companies have experienced significant reductions in stock valuations. COMPASS Pathways (Nasdaq:CMPS), for instance, saw its stock price fall 64% in 2022, while ATAI Life Sciences’ share price dropped 67%. Cybin and Numinus Wellness saw their stock valuations drop by more than 70%. In addition, MindMed was delisted from the Nasdaq. Its stock has fallen more than 90% this year.

There are other efforts to develop antidepressants as well. In December, for instance, FDA granted Fast Track designation to a neuroactive-steroid–based nasal spray from Vistagen for MDD. The developer recently agreed to acquire privately-held Pherin Pharmaceuticals, which had initially developed the nasal spray.


Filed Under: Psychiatric/psychotropic drugs
Tagged With: antidepressant landscape
 

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 >

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
depression sadness and loneliness concept art illustration of wo
Precision psychiatry: A data-driven approach to personalized depression treatment
“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
    • Webinars
  • Pharma 50
    • 2025 Pharma 50
    • 2024 Pharma 50
    • 2023 Pharma 50
    • 2022 Pharma 50
    • 2021 Pharma 50
  • Advertise
  • SUBSCRIBE