Cookies

Like most websites The Medicine Maker uses cookies. In order to deliver a personalized, responsive service and to improve the site, we remember and store information about how you use it. Learn more.
Discovery & Development Drug Discovery, Dosage Forms

(Un)Treatable

Once a club drug of a bygone era, ketamine has found a new lease of life as an FDA-approved treatment for treatment-resistant depression. According to the WHO, depression is the leading cause of disability worldwide (1). Treatment-resistant depression (TRD; a failure to respond to two different types of antidepressant at an adequate dose and sufficient period of time) affects 50 percent of all patients with depression and carries an increased risk of suicide (2).

In September of 2018, Janssen announced its New Drug Application (NDA) to the FDA for the approval of a novel esketamine-based nasal spray for the treatment of TRD last year - and in February the drug was recommended for approval by the FDA’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee (3). 

The drug will be used alongside conventional oral antidepressants. 

“We decided to pursue development of an enantiomer - or one side of the ketamine molecule - because it could be formulated as an intranasal medicine (nasal spray), thus potentially allowing appropriate patients in need to have access to it,” a spokesperson from Janssen explained.

Though the mechanism of action of ketamine is not completely understood, it is thought that the drug acts upon the glutamate system allowing brain cells (neurons) to reconnect, thus improving synaptic plasticity (the efficiency of information transfer through synapses – the junctions between neurons). Though there were delays in the approval process due to the US government shutdown, Janssen has already filed for approval in the EU and intends to do the same in other international markets.
 
 

Enjoy our FREE content!

Log in or register to gain full unlimited access to all content on the The Medicine Maker site. It’s FREE and always will be!

Login

Or register now - it’s free and always will be!

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine
Register

Or Login via Social Media

By clicking on any of the above social media links, you are agreeing to our Privacy Notice.

  1. 1. WHO, “Depression”. Available at https://bit.ly/2RKuN3v. Last accessed March 29, 2019.
  2. 2. Priory Group, “Supporting treatment resistant depression”. Available at https://bit.ly/2RX3Mx2. Last accessed March 29, 2019.
  3. 3. Janssen, “Janssen Submits Esketamine Nasal Spray New Drug Application to U.S. FDA for Treatment-Resistant Depression” (2018). Available at https://bit.ly/2Or6ZmZ. Last accessed March 29, 2019.

About the Author

Maryam Mahdi

Assistant Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:

  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine

Register