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(NBC) – The US Food and Drug Administration on Tuesday approved esketamine, an experimental nasal spray that contains the active ingredients of ketamine, the drug club, as a new treatment for severe depression.
Johnson & Johnson Nasal Spray is a variant of anesthetic ketamine – a painkiller widely used as a street drug, the Special K, in the 1980s and 1990s. The recently approved FDA drug is the first major depression treatment to reach the US market for decades. It is especially effective in patients who have not benefited from at least two different therapies, also known as treatment-resistant depression, the FDA said.
"There has long been a need for additional effective treatments for refractory depression, a serious and life-threatening disease," said Dr. Tiffany Farchione, Acting Director of the Division of Psychiatry Products at the Center for Drug Evaluation and Research. from the FDA. said Tuesday in a statement.
Intravenous ketamine infusions have been shown to help people with severe depression who have suicidal thoughts, but the painstaking process of administering the drug could be frustrating for patients. Experts believe that the FDA's approval of fast-acting, easy-to-use spray treatment is a pivotal moment in the history of mental health therapy.
"This is an extremely important new treatment for people suffering from treatment-resistant depression," said Dr. Gerard Sanacora, professor of psychiatry at Yale University and director of the Yale Depression Research Program at NBC News. "We know that if you do not respond to the first two classes of standard antidepressants, the chances of responding to a third or fourth class decrease significantly. This drug, which has a completely different mechanism of action, is particularly effective for standard treatment steps.
Drug manufacturers believe the spray can help 30-40% of patients who do not respond to antidepressants.
The spray works faster than other known treatments, such as antidepressants, which can take two weeks or more to produce their effects, and have benefits after only four hours.
"This is extremely important for people who need a drug that offers faster clinical benefit. Esketamine can shorten the duration of hospitalization or be used in people who have imminent thoughts or risk getting hurt, "Sanacora said.
Depression is very common. According to the World Health Organization, 300 million people are affected and nearly 800,000 commit suicide. In the United States, between 2013 and 2016, 8% of US adults suffered from depression over a given 2-week period, and about 80% of adults reported at least some difficulties at work, at home, or at home. at social events because of their symptoms of depression, according to the control centers and disease prevention.
Although not all people with depression think about suicide, the risk of suicide in their lives for someone with depression is about 20 times higher than that of the general population, even among those who receive adequate treatment.
The warning signs are not always obvious and can vary from person to person. Some people clearly explain their intentions, while others keep their thoughts and feelings secret suicidal, thus highlighting the importance of timely and effective treatment.
"Depression is thought to be the leading cause of disability in the world. At the individual level, there is a close relationship between depression and suicide. In the United States, more than 40,000 people die each year from suicide, and up to 17% of people experience depression at any given time. So it's not only very common, but it can have very serious consequences, which is a dangerous combination, "said Sanacora.
The discovery of the effects of ketamine on depression was unexpected and researchers still do not know how the drug works differently between those who suffer from severe depression and those who suffer from mild forms.
In February, a federal advisory committee said the benefits of nasal spray outweigh the risks. The group noted that side effects, including dizziness, nausea, increased blood pressure and an uncomfortable feeling of dissociation, should be discussed with patients.
Sanacora, who was the main author of a consensus statement that supported the use of ketamine in the treatment of mood disorders, said the drug was safe, but stressed his potential for abuse, warning that the drug is still not recommended for home use. .
"We are far from the fact that it is a drug at home or over the counter. Misuse of medication is a real concern for this class of drug. So the plan is to give the drug to the providers who would then administer the drug to the patients on the spot, "said Sanacora.
While today is an exciting new step for the development of new medicines, he said, experts believe more research on its long-term use and measures to limit access teenagers will play an important role in the success of the drug.
"Studies of the long-term effects of esketamine have been conducted for up to one year, and an extension study is underway. With regard to esketamine, there was no evidence of cognitive impairment or bladder disorder, as has been observed in studies in animals and in those with frequently used ketamine inappropriately, "said Sanacora.
"Most antidepressants are studied up to 8 weeks, so having these data over one year is pretty unique," he added.
Previously, the use of ketamine infusions to treat depression was not covered by insurance and sessions ranged from $ 350 to $ 700. The wholesale price of the Johnson & Johnson nasal spray depression treatment, Spravato, will cost $ 590 for a dose of 56 mg and $ 885 for 84 mg, the FDA said in a statement. Insurance coverage is provided.
Currently, Eli Lilly's Symbyax is the only drug approved by the FDA for the treatment of treatment-resistant depression.
"Esketamine should not be used in place of Prozac. This is intended to be used alongside standard treatments and not in place of standard treatments. We want people to use medicines responsibly and rationally, "said Sanacora.
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