After a complete review by the healthcare provider Ahew Inc.‘s EHVVF IND application, the US Food and Drug Administration (FDA) authorizes the company to proceed with a clinical trial assessing low-dose, weekly intravenous (IV) ketamine infusion in participants with major depressive disorder (MDD) Have done
It looks like the FDA is giving more permits for clinical studies with ketamine. it recently Only one drug approved for the prevention of injury in organ transplants.
As defined, this open-label trial will include 35 participants with an inadequate response to at least two FDA-approved antidepressant therapies, including a current course of antidepressant therapy at an adequate dose and duration for the current episode .
Ahew CEO ben kaplan The upcoming clinical trial on IV-ketamine infusion in patients with MDD represents an important milestone for the company’s clinical programs.
“Intravenously administered ketamine may offer potential for remission of symptoms in patients with MDD; However, it has not yet been approved by the FDA for this purpose. This study will use an electroencephalography machine to measure brain activity and response while intravenous ketamine is being delivered,” Kaplan said.
Ahwe board members Dr. Ali said one approach is to study the effects of IV ketamine by looking at changes in brain activity on the EEG Ca “help advance Identification of potential biomarkerswhich could one day be used to identify specific patients who would respond best to ketamine intervention, allowing it to be recommended sooner in the course of the disease and reducing the amount of trial and error with treatment options .
Forms of administration and indications for treatment
Faced with 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 are often ineffective in severe cases. I do not help. The dissociative anesthetic ketamine has been repurposed as an off-label analgesic and antidepressant.
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 The more traditional method of administration is because it has long been used as an anesthetic in very high doses.
Ahave says that IV administration of ketamine includes advantages such as greater dosage control and lower cost of drug acquisition, as shown by the many outpatient clinics offering IV-ketamine therapy for MDD across the US.
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