A sure shot treatment for depression has been elusive. But a newly approved option offers hope for millions. The US Food and Drug Administration (FDA) approved a prescription treatment for depression, which has been derived from ketamine, the powerful anesthetic that has been used illegally as a club drug.
The new anti-depressant, a chemical cousin of ketamine, is called esketamine, and will be sold as a nasal spray under the name Spravato, developed by Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson.
It promises to be an effective drug, but only to be used by patients who have tried at least two other medications without success. It’s a fast-acting drug and works quicker than other anti-depressants.
It is to be taken as a oral anti-depressant, only at the administration of a healthcare professional, says the press release. The report says it may also be self-administered but only under the supervision of a care provider and cannot be taken home.
Dr Tiffany Farchione from FDA's Center for Drug Evaluation and Research, said in the statement:
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.
The Study Which Lead to the Approval of Esketamine
A study published in the American Journal of Psychiatry is one of the key findings that led to the recent US Food and Drug Administration (FDA) approval of esketamine nasal spray, in conjunction with an oral antidepressant, for use in people with treatment-resistant depression.
This trial of esketamine was one of the pivotal trials in the FDA’s review of this treatment for patients with treatment resistant depression. Not only was adjunctive esketamine therapy effective, the improvement was evident within the first 24 hours. The novel mechanism of action of esketamine, coupled with the rapidity of benefit, underpin just how important this development is for patients with difficult to treat depression.Michael Thase, Professor at the University of Pennsylvania in the US
The study was conducted at 39 outpatient centres from August 2015 to June 2017 and involved nearly 200 adults with moderate to severe depression and a history of not responding to at least two antidepressants.
During the research, participants were randomly assigned to one of two groups. One group was switched from their current treatment to esketamine nasal spray (56 or 84 mg twice weekly) plus a newly initiated antidepressant.
The other group was switched from their current treatment to a placebo nasal spray in combination with a new antidepressant, said the study.
The improvement in depression among those in the esketamine group was significantly greater than the placebo group on day 28. Similar improvements were seen at earlier points in time, said the study.
Adverse events in the esketamine group generally appeared shortly after taking the medication and resolved by 1.5 hours later while patients were in the clinic.
Researchers say that the dosage will depend on the patient’s severity of illness – once every week or once every other week.
CNN reported that the side effects of Spravato include dizziness, nausea, vertigo, anxiety, lethargy, increased blood pressure, vomiting, feeling drunk, decreased sensitivity, sedation and dissociation, a feeling of being temporarily "disconnected" from your body and your mind.
It will be labelled with the risks. And due to this reason, the patient has to be monitored after administration and should be done at home without supervision.
It is touted to be the treatment for major depression, where other currently available treatments are ineffective in 30 to 40 percent patients, according to CNN.
(With inputs from IANS)
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