The U.S. Food and Drug Administration (FDA) approved intranasal esketamine, a type of esketamine sold as SPRAVATO CIII Nasal Spray, in March 2019 to treat individuals with treatment-resistant depression (TRD).
What is Esketamine
it is a powerful form of the chemical, an FDA-approved anesthetic that has been used for 50 years in medical settings. Esketamine is normally administered intravenously to treat depression off-label, in contrast, esketamine is provided through nasal spray at registered facilities and is currently FDA-approved for the treatment of TRD in combination with an oral antidepressant. It is not legal to use it outside of treatment facilities because it is a controlled substance. Esketamine prescriptions are restricted by the FDA through a specific program known as the Risk Evaluation and Mitigation Strategy (REMS) program, which is intended to reduce any potential dangers connected to a medication.
Here’s how it works.
Esketamine increases glutamate activity in areas of the brain that are crucial for mood through a number of intricate biochemical processes. The primary neurotransmitter that stimulates the brain and central nervous system cells is glutamate, which will
1) Help the brain deal with stress more effectively
2) Reverse the brain alterations associated with depression. This boosts resiliency and gives the patient the chance to develop new, more optimistic beliefs and behaviors.
Method of Administration.
Esketamine is given through nasal spray and takes five to ten minutes to administer. Patients must then be monitored for two hours and are not allowed to drive for the rest of the day. Unlike conventional antidepressants, which normally take at least four to six weeks to take effect, the antidepressant benefits may start to manifest in certain people within days. The treatment regimen starts with an acute induction phase that entails giving the nasal spray two times a week for four weeks, as mentioned in the prescribing information for esketamine. The initial dose for this induction phase is 56 mg, however, depending on the patient’s response, the dose may increase to 84 mg during the following visits. At the conclusion of the induction period, if the patient shows indications of the therapeutic benefit, the patient moves into the maintenance phase of treatment.
Side Effects of Esketamine
- Dissociation
- Nausea
- Dizziness
- Drowsiness
- Vertigo
- Hypoesthesia
- Anxiety
- Lethargy
- Elevated blood pressure
- Vomiting
- Drunk sensation
are the most frequent adverse effects of esketamine. Continuously accumulating more information will probably provide new insights into any potential long-term negative effects of ongoing therapy.
Evidence
For people with TRD after years of study that started in late 1990s. Early academic research demonstrated that even single intravenous doses quickly and effectively alleviated depressive symptoms. In patients with TRD, with short-term response rates typically ranging between 60 and 70%. Consequently, three short-term trials, one randomized withdrawal trial, and one open-label longer-term. The safety study led to FDA registration trials examining the antidepressant effects of esketamine in TRD. Two successful efficacy studies, a short-term and randomized withdrawal trial along with a favourable safety profile, led to FDA approval. Esketamine clinic therapy has a sizable positive impact on individuals with TRD, according to meta-analytic analyses that make use of all the data.
How does ketamine differ from conventional antidepressant medications?
The first antidepressant of a new class that primarily relies on glutamate for its mechanism of action is ketamine. It is also the first antidepressant that works faster than usual. Within hours to days after treatment as opposed to the typical four to six weeks.
What kind of people respond best to ketamine treatments?
Ketamine is currently the subject of a lot of excitement and has sky-high expectations, but it is not a magic cure-all. Like all medications, many folks won’t respond to this one either. If they believe that this is their last chance and it isn’t working, it might be distressing. Due to this, we put a lot of effort into preparation. Whether ketamine works or doesn’t work, we need to have a plan in place because that could result in major issues.
Before starting therapy, each patient receives a lengthy consultation with a member of our staff. Patients with a history of depression who have not improved or tolerated antidepressants are good candidates for ketamine therapy, as are those who have had recurring suicidal thoughts.
