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New major depression drug launched! FDA approves new nasal spray formulation with rapid onset of action

Author : admin Time : 2019/12/5 21:14:04Click :

On March 5, local time, the FDA issued a statement saying it agreed to approve the launch of a new nasal spray drug, Spravato (Esketamine), for the treatment of resistant depression. This is the first major depression treatment to enter the US market in decades. Compared to current antidepressants, which may take weeks or months to work, it works within hours.

Spravato can be used in combination with other oral antidepressants and is suitable for adult patients who do not respond to other antidepressants. John Mann, a psychiatrist and researcher at Columbia University, told the Associated Press that Esketamine's "quick action" is a major benefit for patients with major depression.

Developed by Johnson & Johnson, Esketamine is the s-enantiomer of ketamine, and works like ketamine (a powerful anesthetic) by targeting glutamate (different from conventional depression drugs that target serotonin). Esketamine has been approved by the FDA for breakthrough treatment and is included in the fast track.

The new drug has undergone three short-term (4-week) clinical trials and one long-term clinical trial to maintain efficacy. Of these, in three short-term studies, patients were randomized to receive Spravato or a nasal spray containing a placebo. The results showed that in a short-term study, compared with the placebo group, Spravato had a significant effect on the treatment of depression, and some effects were observed within 2 days. Two other short-term trials failed to reach the expected efficacy endpoint. In the long-term efficacy evaluation trial, compared with the "placebo spray + oral antidepressant" group, the patients in the "Spravato + oral antidepressant" group showed a stable remission response, and the time to relapse was significantly longer.

Ketamine is a common "party drug" (K drug), which has certain side effects on mental health. For Esketamine, common side effects in patients in clinical trials include dissociation, dizziness, nausea, sedation, dizziness, anxiety, drowsiness, increased blood pressure, and vomiting. Taking this medicine may lose your concentration, thinking ability, reaction speed, and judgment.

Considering these issues, Spravato is accompanied by a black box warning (abuse, possible risk of suicide), so Spravato must be taken at a certified healthcare provider hospital or office, and patients need to be observed for two hours after receiving the drug.

Spravato costs $ 590 to $ 885 per treatment, twice a week, up to $ 4,720 for the first month, and $ 2,360 to $ 3,540 per month for subsequent maintenance treatments.

Some experts said the test results were not enough to warrant approval at this time. "The threshold is two adequate and well-controlled trials, and now Spravato has only one." Erick Turner, a psychiatrist at Oregon Health and Science University, told STAT last month. However, the treatment of severe depression is limited and the condition is special, so this may be an important reason for the final approval.