The FDA Recommended Esketamine For Approval, & It Could Be A Game Changing Depression Treatment
Severe depression has proven difficult to treat with the current medications available on the market. However, the pharmaceutical industry had a major breakthrough this week about a potential to treat this mental health disorder. As Business Insider reported, an esketamine nasal spray developed by Johnson & Johnson just became one step closer to being approved by the FDA to treat depression and suicidal thoughts — and it's a huge deal.
On Feb. 12, a group of expert panelists assembled by the FDA recommended the nasal spray in a vote. The panel voted 14 to 2 in favor of the drug's effectiveness for depression treatment, and 15 to 2 in regards to its safety profile. As Business Insider science reporter Erin Brodwin wrote, esketamine is "the chemical mirror image of ketamine, and thought to have slightly fewer side effects than the original compound."
According to Yale Medicine, ketamine is currently not an FDA-approved treatment option for depression, but it has proven to be a successful option for many people with treatment-resistant depression — with studies reporting ketamine was 40 to 60 percent effective in participants. What's more, as Tonic reported, research has shown that ketamine may also treat severe asthma, as well as both acute and chronic pain. Ketamine is arising as a promising treatment for a wide variety of physical and mental health issues, but the long-term side effects of ketamine treatments is unknown.
Essentially, esketamine has the potential to deliver the same benefits as ketamine, with fewer health risks. (Ketamine is an anesthetic that has a reputation as the "party drug" Special K.) While ketamine is typically dosed intravenously through infusions or through intramuscular injections, Johnson & Johnson's esketamine formulation allows the drug to be delivered through a nasal spray.
In double-blind study conducted by Janssen, Johnson & Johnson's pharmaceutical companies, the esketamine spray increased the amount of time between study participants' relapse of depressive symptoms. Specifically, only 25.8 percent of adults given the esketamine nasal spray had a relapse in depression over a 16-week period, compared to 57.6 percent of people placed on a placebo spray. While the research was positive overall, the study discovered common side effects of the spray included dissociation, nausea, metallic taste, headaches, vertigo, and dizziness in some of the patients.
“I think esketamine has the potential to be a game-changer in the treatment of depression [...] I use the term potential because the issues of cost, and patient accessibility need to be addressed," Walter Dunn, a panel member who voted in favor of moving forward with experimental nasal spray, told Reuters. Ketamine infusions are currently expensive — in part because they do not have FDA approval, or coverage under health insurance — but the esketamine nasal spray, Dunn said, may still present similar cost barriers to folks who could benefit from the medication.
Further, panelist Kim Witczak, who voted against the medication, told Reuters that, "There is a lot of potential for people that just want that quick fix. I really would be cautious."
According to the World Health Organization (WHO), 300 million people across the globe are believed to live with depression, and the mental illness is considered the leading cause of disability worldwide. Unfortunately, as Medical News Today reported, that 2018 study discovered that traditional antidepressants on the market — such as selective serotonin reuptake inhibitors (SSRIs) — are only effective for one-third of people with depression.
This step towards the approval of Johnson & Johnson's nasal spray is a huge win. If given the go-ahead by the FDA in March, which is when the vote is expected, the esketamine spray has the potential to dramatically change the lives of millions of people with depression.