Photo by Susan Murphy
Five years before the Federal Drug Administration approved a new anti-flu spray antidepressant called Esketamine, doctors in San Diego were testing it on patients as part of clinical trials of the drug.
"I think this will be an exciting improvement in the way we provide assistance to people with severe depression," said Michael Plopper, M.D., director of clinical research at the Sharp Mesa Vista hospital.
"This is the first new antidepressant drug to come forward in many, many years," Plopper said. "But in reality, it is the most important introduction of a new drug since Prozac in the 80's".
Esketamina, developed by Johnson & Johnson and approved by the FDA on March 5, is an anesthetic related drug and the ketamine drug.
"It is specific to people who have what is called" treatment-resistant depression, "he said.
Currently, only about a third of people taking antidepressant drugs have complete remission, Plopper said.
"And then the middle third has a sort of response but not a remission," he explained. "But we are left with about a third of people who have a severe depression who do not respond to available drugs."
Plopper, who oversaw several clinical trials with Esketamine on 25 patients, said that Esketamine is effective and fast.
"There is a rapid reduction in symptoms – a matter of hours or days against weeks or months that we experience with typical antidepressants," he said. "We are very, very happy to see him come to fruition."
There has long been an urgent need to treat major depression, he said, because the life-threatening condition can lead to suicide.
"Suicides are up," Plopper said. "From 1999 to 2016, suicide incidents increased by about a third at that time, and that is a lot. Predominantly, the increase was among adolescents and the increase was among middle-aged men."
Plopper said plans are underway to open a new hospital-certified clinic to administer the new drug, as part of the stringent FDA requirements.
"People will not be able to take this drug at home," he said. "It must be monitored by a healthcare professional and people must remain for two hours after the drug is given."
He hopes the nasal spray will help a growing number of patients to Sharp Mesa Vista, a mental health facility that provides 158 hospital beds and helps people suffering from schizophrenia, bipolar disorder, severe depression and Alzheimer's disease.
"And then among our outpatient services we have about 400 people a day who come to our intensive outpatient programs," Plopper added.
The nasal spray will be marketed under the Spravato brand. Side effects may include hypertension and temporary illusions.
Johnson & Johnson reports the wholesale cost of each treatment range from $ 600 to $ 900. It is not clear how much insurance coverage will cover.
"I predict (insurance companies) why it will be such an improvement in the way we provide assistance," said Plopper.
To view PDF documents, download Acrobat Reader.