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After a full review of healthcare provider Ehave Inc.‘s EHVVF IND application, the U.S. Food and Drug Administration (FDA) has authorized the company to proceed with a clinical trial assessing low-dose, weekly intravenous (IV) ketamine infusion in participants with Major Depressive Disorder (MDD).
The FDA seems to be granting more permits for clinical studies with ketamine. It recently approved the same drug for the prevention of injury in organ transplants.
As defined, this open-label trial will involve 35 participants with an inadequate response to at least two FDA-approved antidepressant therapies, including the current course of antidepressant therapy, at a sufficient dose and duration for the current episode.
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Ehave CEO Ben Kaplan says the upcoming clinical trial on IV-ketamine infusion in patients MDD represents a key milestone for the company’s clinical programs.
“Intravenously administered ketamine may offer the potential for the remission of the symptoms in patients with MDD; however, it has not yet been approved by FDA for this purpose. This study will use an electroencephalography machine to measure the brain’s activity and response while the intravenous ketamine is being delivered,” Kaplan stated.
Ehave board member Dr. Ali added that studying the effects of IV ketamine by observing changes in brain activity on EEG is an approach that can “help advance the identification of potential biomarkers, which could one day be used to identify the specific patients who will respond best to ketamine intervention upfront, allowing the recommendation to made sooner in the course of illness and decreasing the amount of trial and error with treatment options.”
Forms Of Administration And Treatment Indications
Facing the fact that currently FDA-approved depression treatments such as selective serotonin reuptake inhibitors (SSRIs,) serotonin-norepinephrine reuptake inhibitors (SNRIs,) monoamine oxidase inhibitors (MAOIs,) tricyclic antidepressants (TCAs) and psychotherapy often do not help severe cases, the dissociative anesthetic ketamine has been repurposed as an off-label analgesic and antidepressant.
Research on ketamine’s rapid antidepressant effects have been a breakthrough specifically for disorders such as MDD.
Clinical research and real-world feasibility have shown disadvantages of this administration route for ketamine, including patient discomfort, greater risk of diversion to the illicit market, and potentially serious adverse reactions.
On the other hand, IV use of racemic ketamine is the more traditional way of administration as it has long been used as an anesthetic at much higher doses.
Ehave sustains that IV administration of ketamine includes benefits such as greater dose control and reduced cost of drug acquisition, as the many outpatient clinics offering IV-ketamine therapy for MDD across the US seem to show.
Photo courtesy of True Touch Lifestyle and Gorodenkoff on Shutterstock and Doc James on Wikimedia Commons.
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Image and article originally from www.benzinga.com. Read the original article here.