This is the first antidepressant to be approved by the FDA in 30 years.
Управление по санитарному надзору за качеством пищевых продуктов и медикаментов США (FDA) одобрило новое лекарство против депрессии, которое будет выходить под брендом Spravato. Об этом говорится in a press release on the department's website.
A little less than a month ago on the magazine’s website Nature came out article, which stated that 14 of the 16 FDA advisory panel members approved the drug. Now the final decision has been made.
The medicine is produced by the company Johnson & Johnson. It is based on esketamine, an enantiomer of ketamine (a substance of the same composition, but with a different structure). This form has enhanced analgesic and anesthetic effects. To use it, simply spray the spray into the nose, and the effect (improved mood) will occur within a few hours, while other antidepressants require weeks.
Modern antidepressants, such as Prozac, act by inhibiting serotonin reuptake. An increase in the amount of this neurotransmitter leads to improved mood, but Spravato acts differently. Esketamine is an antagonist of NMDA receptors that interact with glutamate. Thus, it inhibits the functioning of neurons, but reduces suicidal tendencies in clinical depression.
Esketamine has several significant disadvantages. First, it can cause serious side effects: temporary hallucinations, impaired consciousness, dizziness, decreased sensitivity, lethargy, feeling drunk, increased blood pressure and vomiting. However, in short-term experiments, the spray “demonstrated a statistically significant effect compared with placebo.” Secondly, one session in the USA will cost almost $900. Because of these factors, the FDA has indicated that its use is only approved in certified clinics. It should be taken twice a week for a month, while experts do not rule out combinations with other medications.
Kiev center Expio is the first and only medical institution providing ketamine therapy in Ukraine.