Esketamine products like Sparvato will not be made available in the United Kingdom for treatment-resistant depression due to many uncertainties. The drug is currently available in the United States for patients unable to be cured by conventional antidepressants.
Esketamine products like Janssen’s Sparvato have proven effective in patients struggling with a tough battle of depression.
NICE released a document on Wednesday highlighting question marks in esketamine studies that were submitted.
Sparvato antidepressant nasal spray was approved by the FDA in 2019 for treatment-resistant depression.
Sparvato (esketamine) was developed by Janssen Pharmaceuticals and approved by the US Food and Drug Administration (FDA) in 2019 to treat adults resistant to antidepressants. However, officials across the pond in the UK are not willing to medicate depressed patients with esketamine products.
On Dec. 14, 2022, the UK’s National Institute of Health and Care Excellence (NICE) released a 50-page report against inquiries by Janssen to see esketamine nasal spray available for treatment-resistant depression.
NICE didn’t agree with study methods only featuring patients who have had at least three antidepressants previously, with or without treatments such as antipsychotic medicine or lithium. The pool of people in the drug maker’s study was not up to NICE’s standards. NICE found not enough evidence was conducted for practitioners on how to advise the use of esketamine in NHS care.
Current medications for depression include:
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
- Atypical antidepressants
- Tricyclic antidepressants
- Monoamine oxidase inhibitors (MAOIs)
What is a major depressive disorder?
Depression (major depression disorder) is a serious medical illness that negatively impacts your thoughts and actions. Symptoms may include mild to severe symptoms of low energy, loss of interest in former hobbies, sadness, weight fluctuation, and even thoughts of suicide.
According to the World Health Organization (WHO), 280 million people in the world have depression and over 700,000 people die due to suicide every year. In the US 6.7% of adults are affected by depression each year, with 16.6% of people experiencing the illness at some point while living.
What is Esketamine?
Esketamine scientifically is the S-enantiomer of Ketamine, currently an approved anesthetic by the FDA for treatment-resistant depression. However, it has not been approved in other countries around the globe to treat depression.
Ketamine is a street drug also known as “Special K,” creating a sense of euphoria which can lead to detrimental addiction.
Some side effects of esketamine include:
- feeling sleepy
- spinning sensation
- feeling anxious
- lack of energy
- increased blood pressure
- feeling drunk
- feeling very happy or excited
How is esketamine available in the US?
The FDA approved Spavarto (esketamine) for use in 2019 but it is only available for patients struggling with depression with at-least two attempts of antidepressant treatments. The antidepressant nasal spray is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy (REMS).
Spavarto warns patients of possible sedation and is not available for take-home use This makes mandatory monitoring for two hours after receiving a dose by a healthcare provider a necessity.
Dr. Tiffany Farchione, former acting and current director at the FDA highlighted hope for depressed patients clawing through depression back in 2019.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," Farchione said. “Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA’s drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment.”
How effective is esketamine?
A study was conducted to test the efficiency of esketamine and oral antidepressants. They found the drug to be substantially productive for depressed patients in traumatic episodes of depression.
They found 26.7% of people in the esketamine and antidepressant group experienced relapses and 45.3% in the antidepressant and placebo group. Therefore esketamine is slightly more efficient at treating depression but causes more side effects. The research documented 20.4%-27.0% showed signs of adverse effects such as transient dysgeusia, vertigo, dissociation, somnolence, and dizziness. Less than 7% of those in the placebo group experienced such effects. The study included a limited 494 people.