Esketamine, a new drug potential applications to treat depression, is in its final stages of testing before being submitted for approval by the U.S. Food and Drug Administration (FDA). Esketamine is a type of ketamine-molecule drug that researchers and health professionals believe can help those with severe depression who have not responded to other treatments,. The FDA typically requires three phases of testing for new drugs before they can be submitted for approval.
What is Ketamine?
According to the Center for Substance Abuse Research (CESAR), ketamine was originally developed in 1962 as a general anesthetic but was widely abused. However, by 2006, the National Institutes of Health released a study that demonstrated that ketamine was able to relieve participants of their severe depression within a few hours. The finding was considered a breakthrough, since many who suffer from depression struggle to find the right treatment. Since then, researchers have hypothesized that ketamine’s effectiveness may be rooted in how it restores connections between nerve cells in areas of the brain associated with mood and emotion.
While ketamine is currently FDA-approved for anesthetic purposes, it has been prescribed “off-label” by doctors, which is defined as the “unapproved use of an approved drug.”
The Janssen Pharmaceutical Companies of Johnson and Johnson released the results from two Phase 3 clinical studies in early May, and reported that its esketamine nasal spray and newly initiated oral antidepressant “marks the first time an antidepressant has achieved superiority in a clinical trial for major depressive disorder that included a newly initiated oral antidepressant in both the control and placebo groups.”
Many are eager to push esketamine forward, as depression remains a problem for many Americans and Johnson and Johnson’s report states, “although currently available antidepressants are effective for many patients, about one third of patients do not respond to treatment and are thought to have treatment-resistant depression.”
Holdbacks and Concerns
While many researchers and health professionals are excited about bringing esketamine to the market, some physicians and scientists still have some reservations. An article signed by the majority of the board of the American Journal of Psychiatry argued that pharmaceutical industry scientists should be proceeding with caution, especially since ketamine and ketamine-related drugs have been abused in the past. Dr. Robert Freedman, one of the authors of the article, said in an interview with The Washington Post that he and his team “felt it was a problem that really needed particular attention [because] it at least has the potential for causing similar problems to the opioids…that was our single overriding concern.” In the article, it is reported that “ketamine drug-seeking behavior has already appeared as a clinical issue, with some patients shopping infusion clinics to obtain repeated injections for mood elevation,” and that “some patients use intravenous formulation intranasally repeatedly without supervision.”
Additionally, according to an article from March 2018 published in Science Daily, some researchers believe that since ketamine and ketamine-based treatments are administered as a nasal spray, the treatment can affect patients differently since “Absorption will vary between people and can fluctuate on any given day within an individual based on such things as mucous levels in the nose and the specific application technique used.”
However, since esketamine is a type of ketamine molecule, researchers note that it seems to bring fewer serious side effects. Ketamine, by contrast, is known to produce hallucinations. According to Johnson and Johnson’s Phase 3 trial results report, the most common side effects of its nasal spray and oral antidepressant were “metallic taste, nausea, vertigo, dizziness, headache, drowsiness, dissociation, blurred vision, paraesthesia (tingling sensation) and anxiety.”
When Will Esketamine be Available?
As it stands, Johnson and Johnson is planning to submit its esketamine nasal spray and oral antidepressants to the FDA later in 2018, and costs were not specified by Johnson and Johnson. As noted earlier, ketamine can be prescribed by health professionals if necessary, but intravenous ketamine therapy in the U.S. may range from $400 to $800, and is not covered by insurance.
However, antidepressants are typically covered by health insurance, but consumers should follow up with their respective providers.
For reference, the National Suicide Prevention Lifeline can be reached at 1-800-273-8255.
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