Five years before the Federal Drug Administration approved a novel antidepressant nasal spray called Esketamine, doctors in San Diego were testing it on patients as part of the drug’s clinical trials.
“I think this is going to be an exciting improvement in the way we deliver care for people with serious depression,” said Michael Plopper, M.D., director of clinical research at Sharp Mesa Vista Hospital.
“This is the first new antidepressant medication to come along in many, many years,” Plopper said. “But really, it’s the most important introduction of a new medication since Prozac in the '80s.”
Esketamine, developed by Johnson & Johnson and approved by the FDA on March 5, is a related drug of the anesthetic and party drug ketamine.
“It’s specifically for people who have what’s called ‘treatment-resistant depression,’” he said.
Currently, only about one-third of people who take antidepressant medication have full remission, Plopper said.
“And then the middle third has sort of some response but not remission,” he explained. “But we’re left with about a third of people who have serious depression who don’t respond to the available medications.”
Plopper, who oversaw several Esketamine clinical trials involving 25 patients, said Esketamine is effective and fast.
“There’s a rapid reduction in symptoms — a matter of hours to days versus weeks to months that we experience with the typical antidepressants,” he said. “We are very, very pleased to see it 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 the incidents of suicide annually went up about a third over that period of time, and that’s a lot. Predominantly, the increase was among teenagers and the increase was among middle-aged men.”
Plopper said plans are underway to open a new certified clinic at the hospital to administer the new drug, as part of strict FDA requirements.
“People will not be able to take this medication home,” he said. “It has to be under observation of a healthcare provider, and people have to stay for two hours after the drug is administered.”
He hopes the nasal spray will help a growing number of patients at Sharp Mesa Vista, a mental health facility that provides 158 inpatient beds and helps people who suffer from schizophrenia, bipolar disorder, major depression and Alzheimer’s disease.
“And then among our outpatient services we have approximately 400 people a day coming to our intensive outpatient programs,” Plopper added.
The nasal spray will be marketed under the brand name Spravato. Side effects can include high blood pressure and temporary illusions.
Johnson & Johnson reports the wholesale cost of each treatment ranges from $600 to $900. It’s unclear how much, if any, insurance companies will cover.
“I anticipate (insurance companies) will because it’s going to be such an improvement in the way we deliver care,” Plopper said.
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