The FDA approval of Esketamine, a nasal spray that steams from the popular party drug Ketamine appears to be both practical and fast acting for acute treatment-resistant depression. However, the big question remains about how safe the drug is?
Results from a phase III clinical trial was published this week in the Americal Journal of Psychiatry, which was in place to test the efficacy and safety of Spravato, the FDA-approved esketamine nasal spray manufactured by Janssen Pharmaceuticals.
According to the report, the double-blind, the active-controlled study included 200 patients across 39 outpatient centers over the years 2015-2017. A few patients were given the drug alongside a traditional oral antidepressant, while the placebo group received saline and the conventional oral antidepressant. For a total of 28 days, patients were evaluated for symptom of depression and anxiety at the baseline throughout the treatment.
Researchers claim those given the esketamine displayed more improvements than the other group that was given the placebo. The team also noticed significant improvements in symptoms which started to began as little as 24 hours before the first dose, which proves its fast-acting mechanism.
“This trial of esketamine was one of the pivotal trials in the FDA’s review of this treatment for patients with treatment-resistant depression… The novel mechanism of action of esketamine, coupled with the rapidity of benefit, underpins just how important this development is for patients with difficult to treat depression,” explained Dr. Michael Thase, professor of psychiatry at the University of Pennsylvania and one of the study authors in a press conference.
Just like any other medication, the study revealed suspected side effects; which included dizziness, dissociation, dysgeusia (change or distortion in the sense of taste), vertigo, and nausea. Majority of the people who took it reported the side-effects shortly after dosing and cleared up within 90 minutes.
Experts reported nine people who opted out of the trial after experiencing more severe effects like a migraine, panic attack and feeling drunk.
Despite the nine unfortunate patients, the overall conclusion of the study was that the drug was safe and tolerable for human consumption.
“Most experts and clinicians feel that the marketing of intranasal esketamine will be a boon for a subset of patients who suffer greatly and for whom other currently available treatments have been insufficiently effective,” announced Dr. Timothy B. Sullivan, chair of psychiatry and behavioral sciences at Staten Island University Hospital in Staten Island, NY.
Due to the nature of the drug, many question the safety of the drug, according to a new editorial on the same issue of the American Journal of Psychiatry, Dr. Alan F. Schatzberg, the Kenneth T. Norris, Jr. Professor of Psychiatry and Behavioral Sciences at Stanford University School of Medicine addressed some of those concerns.
“It’s not clear to me that we understand what’s the optimal way of using it, how much we should give, how long we should give it for, [and] what we should do when we stop it,” Schatzberg explained to the press.
“That doesn’t mean that someone shouldn’t go ahead and use it. However, I think there has to be a modicum of caution that we don’t have all the answers,” he concluded.
Schatzberg’s main concerns are the potential for abuse and issues with withdrawal. He claims, like many other drugs, there may be a risk for adverse health events when people stop the use.
A spokeswoman for Janssen highlighted that Spravato nasal spray is the “first new mechanism of action for the antidepressant medication in decades,” noting that before doctors had limited was of treating treatment-resistant depression.
“These findings, which represent part of Phase 3 clinical trial program of more than 1,700 patients, reinforce the robust efficacy and safety profile of the medicine and the significant improvement of depression symptoms that SPRAVATO™ may offer adults with TRD,” read the statement.
Because of medical science, Estketamine is chemically identical to Ketamine, a powerful anesthetic. For years, Ketamine has gained a reputation as a powerful club drug, with the potential to incapacitate the user.
Due to the risks involved with the administration of esketamine, the FDA is only allowing it in hospitals and to be given by a trained clinical professional.
“This unique agent will not be generally available for some time. Although this may be disappointing to some, it is important with any such novel and complex treatment to carefully observe its effects and risks once administered to less controlled and selected populations,” said Sullivan.
“I don’t think we’ve answered all the questions that we need to to be one-hundred percent comfortable, but that doesn’t mean we shouldn’t use the drug,” concluded Schatzberg’s statement.
Author: Mckenzie Santa Maria