"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA?s drug approval process ? were important to our decision to approve this treatment,? said Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research, in a press release.
Studies on ketamine as a treatment for depression began in the late 1990s, when psychiatrist Dr. Dennis Charney and a team of researchers saw that patients with severe depression, who were undergoing operations, were given ketamine and subsequently experienced fewer symptoms. The team quickly got to work on a study, which found similar results and was published in 2000.
The only problem with the study was that ?no one cared,? Charney, dean of the Icahn School of Medicine at Mount Sinai Medical Center, told ABC News.
That was not the case for the next study on ketamine?s effects on people with depression, which was sponsored by the National Institute of Mental Health. After it showed that patients with major depression benefited from two ketamine treatments a week apart from each other, doctors who didn?t have anything else to offer patients with severe depression began treatment with the drug. Several other studies since then have also found success treating depression with ketamine.
Esketamine, which will be sold under the brand name Spravato, is the first drug of its kind marketed specifically for severe depression. It has been in the research and development phase for more than nine years, according to Courtney Billington, president of Janssen Neuroscience, a subsidiary of Johnson & Johnson.
Here?s what you should know about Spravato.
What is esketamine and what would it be used for?Esketamine is a nasal spray derived from ketamine, a medication most commonly used to put people to sleep during an operation. Ketamine has also been given off-label intravenously to people with severe depression for over a decade now. Both physicians and patients have reported rapid improvement in depression symptoms with this treatment, sometimes within hours of taking the first dose, according to Charney.
While Charney said it?s still unclear how the drug fights depression so well, he said it might involve restoring brain cell connections through totally different neurotransmitters than conventional antidepressants.
Charney said that based on his study of ketamine, side effects are generally mild, with the most common ones being dizziness, increased blood pressure, sleepiness and dissociative symptoms ? feelings of being ?detached? from one?s surroundings.
Why is it controversial?Ketamine is used for anesthesia, but it also has a reputation as a ?club drug? ? in high doses, it alters consciousness by distorting vision and sound as well as causing feelings of being detached from one?s environment.
That said, there is currently no evidence that people can become addicted to treatment doses of ketamine, which are much lower than they would be for recreational or anesthetic use. The longest study on its effects against depression show that it can be taken safely for up to a year; however, that?s only because the drug hasn?t been studied for a longer period of time. Charney said that it?s possible the drug could be used for longer than a year, but that patients could potentially be tapered off of it over time, or use it as a ?bridge? while waiting for more conventional antidepressants to work. It is unclear at this time if patients will require ongoing, lifelong treatment, he said.
What happens now?The drug will be available ?as soon as possible,? Billington told ABC News. He said now that the drug has been approved, his team will be working to ensure physicians are properly educated and trained on safe practices.
?Our focus will be on ensuring that health care providers are aware [of the medication],? said Billington, adding that Janssen Pharmaceuticals is ?working hand in hand [with doctors] so that the patients they serve can have access to the treatment.?
That said, access to treatment will be strictly regulated. Esketamine will have to be administered in a certified treatment center ? one that has been credentialed based on certain requirements and where staff is trained to ?reduce the risk of misuse and abuse?[as well as] close documentation of any adverse reactions,? Billington said. Patients, physicians and treatment centers can find more information about the certification process at Spravato.com.
Additionally, esketamine will only be available for people over 18 and will have to be administered at the certified clinic so that patients can be monitored. Treatments will start with two-week intervals and then on an as-needed basis. Like most new medications, Janssen expects that insurance ?reimbursement [will] build over time [and they] fully expect that [it] will be broadly reimbursed,? Billington said.
As a fierce supporter of using the drug to treat depression for almost 30 years, Charney is optimistic.
?The ultimate goal of a scientist in the biomedical field is to make a discovery that will change the lives of patients,? Charney said in an interview with Mount Sinai. ?For me, this is very gratifying because that?s what I?ve tried to do throughout my research career.?
?For those patients who have had depression for years and have never responded to treatment,? he added, ?there is now hope.?
Theresa Scott, DO, MS, is a pediatric resident and member of the ABC News Medical Unit.