This dosage form of antidepressant is supported or listed by the FDA expert group

Medical Network February 18th Recently, the US Food and Drug Administration (FDA) team jointly voted to approve ketamine nasal spray (28mg / time) for the treatment of refractory depression (TRD).

The Panel of Experts on Psychopharmacology and Drugs (PDAC) and the Advisory Committee on Drug Safety and Risk Management (DSaRM) voted for the effectiveness and safety of ketamine with a 14:2 (1 abstention) vote. Based on previous findings and the FDA's risk assessment and mitigation strategy (REMS), they believe that the benefits of ketamine are greater than their risk.

Current status of antidepressant medication

Major depressive disorder (MDD) is a serious chronic mental illness characterized by low mood, reduced interest, pessimism, slow thinking, lack of initiative, poor diet and sleep, etc. Worried about having various diseases and feeling the whole body Many discomforts can occur, and serious suicidal thoughts and behaviors can occur. It is estimated that there are currently about 16 million MDD patients in the United States, and there are more than 41,000 suicides each year, many of which are due to untreated or poorly treated depression.

The first-line treatments for such patients are mainly medication and psychotherapy . Among them, oral antidepressants include selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors and tricyclic antidepressants. These drugs can take several weeks to work, so patients often need to try multiple drugs to find an effective drug.

New dawn in antidepressant drugs

Depression, which has not been significantly improved after at least two different anti-depressant drugs with different mechanisms of action, is called refractory depression (TRD), and such depression often causes pain to the patient. One of the advantages of ketamine is that it can effectively and quickly alleviate the depressive symptoms of such patients, and it is possible to avoid the risk of self-injury or even suicide.

A company conducted 19 Phase I, Phase II, and Phase III Phase III trials of ketamine. One of the long-term Phase III clinical trial data showed that ketamine nasal spray combined with oral antidepressants had statistically significant statistically significant and rapid improvement in patients with depressive symptoms compared with placebo. As Dr. Dunn, a member of the DSaRM committee, said, “I voted in favor because ketamine is likely to be a 'game changer' for treating depression; I call it 'game rule changer' because the drug is Improving refractory depression is better than any of our existing treatments. Second, the rapid response schedule for this drug is unprecedented, and no single antidepressant can improve symptoms faster. Dr. Dunn added that although this compound is not novel, its mechanism of action is very novel.

Concerns from the FDA panel

Although Dr. Hoffer voted for EK, he is concerned about whether the drug will be diverted and abused. Because ketamine is an isomer of ketamine, the latter is a common anesthetic and also a notorious party drug (commonly known as K powder). In addition, some experts expressed concern about the three adverse reactions of ketamine (sedation, block and elevated blood pressure), so the FDA recommended implementing a REMS program to ensure patient safety.

“REMS requires that ketamine be administered only in certain areas of health care , and patients need to be monitored for 2 hours after dosing. This drug cannot be dispensed directly to the patient and the patient must describe the risk associated with ketamine in the registry. Features, the US Food and Drug Administration (FDA) explained in its briefing paper.

The voice of the medical industry

After the ketamine nasal spray was supported by the FDA expert group, the medical community also expressed their views.

Some people hold a positive attitude, and pharmacist abdullah Duayrim particularly expects that these drugs will be recognized internationally as soon as possible. Pharmacist William Preston is also a patient with major depression. He was very pleased to see the news and had great expectations for the drug.

However, some people are also skeptical. Psychiatrist Wade Pinson is more worried about whether ketamine is abused and whether there are unexpected side effects.

Currently, more than 300 million people worldwide are caught in the haze of depression. The FDA is expected to make a decision on whether to approve the listing of acetamine on March 4. Once ketamine is put on the market, it will bring hope for more depression patients.

　　 Original source: Medscape