Adult patients with major depressive disorder (MDD) with active suicidal ideation could benefit from using esketamine nasal spray.
Recently, Janssen Pharmaceutical Companies of Johnson & Johnson officials announced positive results from a pair of phase 3 clinical trials on the efficacy and safety of SPRAVATO (esketamine) CIII nasal spray in reducing depressive symptoms in this population.
While presenting data on this treatment at the 32nd
European College of Neuropsychopharmacology (ECNP) from Sept. 7-10 in Copenhagen, Carla Canuso, MD, Senior Director, Clinical Research, Janssen Research & Development, and David Hough, MD, Esketamine Compound Development Team Leader at Janssen Research and Development, explained in an interview with MD Magazine®
how the spray will be used and why it is an important treatment option for MDD patients.
MD Mag: How important is it to find a treatment for this a segment of the population in particular, which is something very hard to treat?
Depression is the leading cause of disability worldwide and 300 million people globally suffer from depression. And it's a condition that affects all aspects of life and functioning. When you think about, patients who have major depressive disorder have an imminent risk for suicide, it's really important because there are no current treatments that exists. And the treatment options for a patient who's presenting in this kind of a clinical crisis are very limited.
And typically, what we're able to do is to hospitalized patients to keep them safe. And then just antidepressants to treat the underlying condition. But typical antidepressants take 4 or 6 weeks to really exert their full effect. So, they're not very useful at all in an emergency situation. So, the fact that we've developed a drug that's able to bring depressive symptoms under rapid control within 24 hours, as early as 4 hours is really important to the treating clinician and to the patients that are in this acute crisis.
MD Mag: Do you believe that patients will be able to kind have this in their home and will emergency personnel carry it on them similar to how police officers carry Narcan?
It can only be administered at registered sites of care. And it has to be administered by somebody who's received training. Now, it specifies specifically that patients cannot access it at a pharmacy, they cannot administer it. It has to be administered in this these registered sites of care under the supervision of a health care professional. And I think that's the responsible and thoughtful approach, because it really minimizes the potential for abuse or diversion.
MD Mag: Can you kind of explain how effective it is in treating treatment resistant depression?
The regulatory definition of treatment resistant depression is a patient who has failed to respond to 2 or more antidepressant treatments in the current treatment episode. And we have a very robust data package to support the benefits of the treatment and treatment resistant depression. You may know, we've been studying it for over 8 years, we conducted 28 different clinical trials, we had over 1700 patients that participated in those phase 1, 2, and 3 studies. And it was approved, it received breakthrough therapy designation by FDA was approved by an independent FDA advisory committee that looked very carefully at the benefits of risks.
MD Mag: Was esketamine created with the intent to treat the emergency type situation, as well as the long-term treatment resistant disorder?
We've been working on both of these indications for a number of years, the treatment resistant depression was prioritized, and that was approved first, but this 1 has followed closely behind because of the important unmet need. So, we really did look at those indications for several years now.
From a clinical perspective, once it was appreciated that the drug has such rapid effect, it was pretty obvious hypothesis, that this would be a good patient population to treat with it, because they are in need of treatment right away. And because our current therapies are known to take a long time to work.
MD Mag: What are some of the downsides or side effects that are associated with it?
Esketamine is associated with a number of different side effects, and I can name some of the most common ones, which include things like sedation, dizziness, dissociation, nausea, increased blood pressure. But it's important to note that these are not the same types of side effects that you get from some medicines, which are 24/7, the side effects are experienced in association with the dosing, they're transient. And they tend to resolve within 1 to 2 hours after dosing. So, all those side effects I just mentioned, which are relatively common, tend to resolve an hour or 2 to after the dosing. So that that's what makes this I think, you know, a treatment that that will make a big difference whether it's treatment resistant depression, or this new indication.
MD Mag: Is there anything else you are kind of working on with esketamine?
Well, I think at the moment, we're interested in exploring other opportunities that are out there, we're also focused on those indications, submitting them in markets around the world. So, it's a very exciting and a very busy time for us.
And I could add that we are currently studying patients with major depressive disorder with active suicidal ideation and intent in the adolescent population. And that's part of our commitment to regulatory authorities around the world. And of course, it's a patient population, where there is again clear unmet medical needs. So, we're in phase 2 in adolescence at this point in time.