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Spravato is esketamine, which is similar to the party drug and anesthetic known as ketamine.
The drug comes in a nasal spray and is an alternative to the costly and time-intensive ketamine treatments that some individuals turn to amid a lack of new options from top pharmaceutical companies.
The medication reportedly works within hours rather than weeks as is common with other antidepressant drugs.
"There has been a long-standing need for additional effective treatments for treatment-resistant depression, a serious and life-threatening condition," said Dr. Tiffany Farchione of the agency.
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Because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, the FDA said.
Because of safey concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient," the agency she said.
Spravato is for patients with major depressive disorder who, despite trying at least two antidepressant treatments given at adequate doses for an adequate duration in the current episode, have not responded to treatment.
The new drug could lead to a slew of follow-on treatments that promise faster cures for depression without the detrimental side effects that come with existing drugs.
“Expectations should start to change,” VistaGen Therapeutics CEO Shawn Singh, a company developing its own drugs to treat depression and social anxiety, told Fox Business in February. “You really need big pharma’s muscle to say to Wall Street, 'This is worthy of your attention.'”
New Brunswick, N.J.-based Johnson & Johnson is banking on Spravato to be a big money maker for the firm – potentially as much as $1 billion in peak revenue, CEO Alex Gorsky recently told investors.
While J&J manufactures a huge range of products, from medical devices, to drugs and consumer goods, the pharmaceutical division continues to make up for losses in other sectors. Its drug sales grew 12.4 percent to $40.7 billion worldwide in 2018.