FDA Approves Johnson & Johnson's Nasal Spray Antidepressant | INN

FDA Approves Johnson & Johnson's Nasal Spray Antidepressant | INN

In the case of esketamine (sold as Spravato), one of these concerns is that it's related to ketamine, which has been used as an anesthesia and to get high in the form of the once-popular party drug Special K. There's a concern that this new antidepressant may carry a risk of addiction and substance abuse.

The FDA's approval of Spravato is only for patients with depression who have failed to find relief with at least two other drugs.

Experts have said that while conventional antidepressants like the SSRIs or Fluoxetine or Paroxetine, Escitalopram etc. reduce depressive symptoms by increasing release of a chemical serotonin in the brain, Esketamine acts differently.

Spravato will cost between $590 and $885 per treatment.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening.

The Anxiety and Depression Association of America, based in Silver Spring, Maryland, urged the FDA's approval to address what has been called one of psychiatry's most glaring problems.

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The medicine will be available with a warning label that in some people, it can increase suicidal thoughts during the first few months of treatment or if the dosage is changed. But the FDA approval, he adds, is a step toward having another viable and safe treatment for major depression.

"I think we need to be cognizant of not positioning [Spravato] as a wonder drug or as a panacea, because it's not", said Steven Meisel, system director of medication safety at Fairview Health Services in Minneapolis, Minnesota, in an interview with BioPharma Dive.

Approval of the drug, which will be sold by J&J as Spravato, gives a new treatment option for individuals who have previously failed two or more antidepressants, a population that is estimated to account for roughly a third of the 16 million adults in the USA who have had an episode of major depressive disorder. Generic ketamine is approved as an anesthetic, not as an antidepressant.

Patients will then have to remain at the clinic for two hours after using the spray to be monitored by a professional "because of the risk of sedation and dissociation".

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University.

The list price of a drug is not necessarily what patients actually pay. That means twice-weekly treatments during the first month will cost centers that offer the drug at least $4,720 to $6,785.