Doctors have reportedly been prescribing ketamine "off label" for years to patients who have not responded to more standard antidepressant medication. Spravato is a nasal spray from Johnson & Johnson that's a close cousin of ketamine, an anesthetic that's sometimes used recreationally and often known as "Special K".
"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment", added Farchione. Spravato is meant to treat patients who have major depressive disorder (MDD) and have not responded "adequately" to two at least two different types of antidepressants.
"It is not the end all be all even though I wish it was", Levesque said.
After giving IV ketamine to seven patients, "to our surprise, they started saying within a few hours that they felt better", Charney said.
The anti-depressants available at present of the likes of Eli Lilly and Co's Prozac impact the neurotransmitters - serotonin and norepinephrine.
Charney was part of the team that first showed two decades ago that ketamine could treat depression. Nearly instantly, she noticed a difference. It is claimed to lift the mood of the patient within 24 hours of use. "I have forgotten what [it] felt like to be that happy". The approval is a huge boost for Ketamine wellness centers, which have been around for several years.More news: Venezuelan opposition leader returns home
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The Food and Drug Administration on Tuesday cleared the inhalable drug for patients who have failed to find relief with older antidepressants.
"The amount of active ingredient that's in this product, it's at a very, very low dose", Billington said. Dr. Spencer Levesque believes it could help people in the Ozarks.
That means about 5 million of the 16 million people in the US with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson. But she says none of the five medications she tried relieved the depression that has stymied her personal and professional life.
Over 300 million people globally live with major depressive disorders, and the incidence of attempted suicide in people with this condition is about 20-fold higher than that among those without the disorder.
The new treatment is not cheap and is likely not going to be covered by insurance right away. It has been slated to cost around $885 (£673) per treatment.