Spravato (Esketamine) for Treatment Resistant Depression – An FDA Approved “Breakthrough Therapy”
In March 2019, the U.S. Food and Drug Administration (FDA) announced the approval of Spravato (Esketamine) for use in patients diagnosed with treatment-resistant depression.
Spravato is a nasal spray that can only be administered by an approved health care provider, in the physician’s office or clinic, because the main ingredient is a chemical relative of the powerful psychedelic club drug Ketamine.
“There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life threatening condition,” Dr. Tiffany Farchione, acting director of the FDA’s division of Psychiatry Products, said in a statement.
What is Treatment Resistant Depression?
Treatment Resistant Depression (TRD) is more common than people might think.
The National Institutes on Mental Health reports that in 2017, an estimated 17.3 million people – more than 7 percent of the U.S. population – experienced a major depressive episode.
About one-third of those patients, according to research, will receive a diagnosis of treatment resistant depression.
Patients who still suffer symptoms of depression after two rounds of adequately dosed antidepressants taken for a significant amount of time, generally qualify as treatment resistant.
Even with the traditional medications, people with TRD continue to suffer from painful symptoms, including some of the following:
- Incessant feelings of sadness, worthlessness or isolation
- Insomnia and sleep disturbances
- Exhaustion, fatigue or low energy
- Thoughts of suicide or death as a solution to how they feel
To date, Transcranial Magnetic Stimulation (TMS Therapy) has been used as one of the most effective treatments of the condition.
Recent evidence shows that Spravato (esketamine) has also been demonstrated to provide relief for TRD.
The Spravato (Esketamine) Connection to Ketamine
Esketamine is the s-enantiomer of Ketamine.
In 2013, the FDA granted the drug manufacturer “breakthrough therapy” status, a designation that allows for fast-tracking the review of medications for life-threatening conditions.
However, Spravato’s (esketamine) approval hasn’t come without controversy.
Ketamine, known on the street as “Special K,” is a dissociative anesthetic that causes a psychedelic, “out of body,” type of high users refer to as the “K Hole.” Recreational users often compare the drug to LSD or PCP.
Used in a hospital setting, it is an effective anesthetic, but most ketamine that makes it into the hands of recreational users comes from underground labs or is stolen from places like veterinarian clinics and, likely, cut with other unknown substances before its sold.
Some of the negative side effects of using ketamine recreationally can include:
- Severe anxiety
- Paranoia and psychosis
- Delirium and catatonia
- Chest pains
- Nausea and vomiting
Regular ketamine users do develop a tolerance to the drug and have to take higher doses to achieve similar highs.
Because there are fears among experts about abuse and potential addiction, the FDA restricts the use of Spravato (esketamine) to a physician’s office.
Patients are not allowed to take the medication home.
“Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient,” Dr. Farchione noted in her statement.
Clinical trials of Spravato for treating treatment resistant depression, where patients were administered the medication as prescribed by the FDA, showed the risk of addiction and abuse to considerably unfounded, reports CNN Health.
Ketamine Infusion Therapy
The promise of ketamine to treat depression, and the potential to help with addiction, post-traumatic stress disorder (PTSD), chronic pain and possibly other disorders has led to off-label prescription uses of the medication, know as ketamine infusion therapy.
With ketamine infusion therapy, the medication is dosed based on a person’s weight, and administered through an IV drip. Advocates of this type of therapy claim startling and fast results. There is some research to back them up.
A study published in the American Journal of Psychiatry reported that participants with major depressive disorder found relief from suicidal thoughts in just 24 hours.
Typically, a ketamine infusion therapy session lasts about 45 minutes and patients are required to have someone that can transport them home after the session due to the dissociative effects of the drug.
Because the treatments are off-label, insurance companies are unlikely to cover the costs and therapy can be quite expensive.
For now, though, Spravato (esketamine) has been approved for use with an oral antidepressant and is a promising and more affordable option for people living with treatment resistant depression.
It is also the only form of ketamine-like treatment accepted by the FDA.
Dr. Akikur Mohammad of Inspire Malibu is one of the first doctors in southern California to be certified to administer Spravato (esketamine) for treatment resistant depression. He has also been using TMS Therapy to treat depression and addiction for over a decade.
For Information About Esketamine Treatment for Depression, Call Us at 800-444-1838.
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