Johnson & Johnson's Spravato (ingredient: esketamine), a new nasal spray depression treatment, has raised some concerns among experts over its efficacy and high price, although it is an essential drug for therapeutic resistance patients.
|J&J's nasal spray depression treatment Spravato|
Spravato uses the first new mechanism of action (nasal spray) in decades to treat the major depressive disorder in decades.
The U.S. Food and Drug Administration recently approved the drug for patients struggling with major depressive disorder (MDD) due to treatment-resistant depression (TRD) and have not responded adequately to at least two different antidepressants of adequate dose and duration.
The drug has received much attention since its clinical phase as medical professionals considered that the nasal spray method would become a good alternative for patients as it can show fast effects due to its deployment method while treating those who did not have any treatment progress with conventional treatments.
However, patients can only inhale Spravato in a licensed practice room with the presence of a doctor at all times. Also, hospitals have to go through a two-hour observation period to make sure that the patient does not show any side effects, while the patient cannot leave the hospital without permission from their doctor.
Such precautions are due to the reported adverse reaction of Spravato. So far, the reported side effects of the drug include out-of-body experience, disassociation, dizziness, anxiety, vomiting and feeling drunk.
Some of the major clinical trials submitted to the FDA reported that they failed to meet the primary efficacy endpoint, while six patients reportedly took their own lives or died following the drug's administration.
Although it has been concluded that the causal relationship between drug use and death is not clear, Spravato still has a warning label addressing such concerns on its product packaging. There is also still a need for safety clinical trials to confirm the drug's long-term use and cease of treatment.
At the same time, U.S. experts have also raised concerns over the high price of the drug.
According to the U.S. Institute for Clinical and Economic Review (ICER), Spravato costs between $4,720 and 6,785 for twice-a-week administration for the first week. After the first month, the drug will cost patients $2,360 to $3,540 per month.
ICER questioned the cost-effectiveness of Spravato.
"Esketamine shows some benefits for such patients and provides an FDA-approved treatment for TRD that may be covered by payers; however, it is concerned to have an overpriced therapy where there is such need for treatment," ICER's chief medical officer, David Rind. said. "Additionally, the similarity of ketamine to esketamine raises issues for all stakeholders about how to consider off-label prescription and coverage of a treatment that has not been as well studied but is being increasingly used for TRD."
It is uncertain if J&J plans to market the drug in Korea, market sources here said, adding that even if the company plans on bring the drug, it may take some time until it manages to launch the product.
As Spravato's main ingredient esketamine is classified as a psychotropic drug, the approval process is more complex and challenging as the relevant ministry can only reevaluate the drug with data from clinical trials conducted in Korea, they said.
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