Janssen, Johnson & Johnson’s pharmaceutical unit, has won FDA approval for its nasal spray ketamine-based treatment for depression. The drug, esketamine, marketed as Spravato, is closely related to the widely used anesthetic ketamine, which is sometimes used as a party drug called “special K.” Like its better known cousin, esketamine can cause hallucinations and out-of-body experiences, but it is thought to generally have fewer side effects.
Spravato is the first new type of antidepressant in decades. Doctors interviewed by the New York Times welcomed the new, fast-acting treatment, but noted that the cost is high: $4,720 to $6,785 a month to start with, and $2,360 to $3,540 a month to continue.
So far, the drug has been studied on 1,700 patients who did not respond to two different standard antidepressants.
“Thank goodness we now have something with a different mechanism of action than previous antidepressants,” Dr. Erick Turner, a former F.D.A. reviewer and an associate professor of psychiatry at Oregon Health & Science University told the Times. “But I’m skeptical of the hype, because in this world it’s like Lucy holding the football for Charlie Brown: Each time we get our hopes up, the football gets pulled away.”
A press release from Janssen’s Titusville office said when the drug is prescribed, it will be given under the supervision of doctors rather than allowing them to take doses home and take them on their own. The drugmaker also advised healthcare providers to monitor patients for blood pressure changes and out-of-body experiences for two hours after each dose.
Ketamine was already being used to treat depression, with clinics delivering the anesthetic intravenously, off-label. One company operating such clinics is Actify Neurotherapies, headquartered on Bunn Drive, which has a network of nine locations that give the drug for major depression, PTSD, bipolar disorder, obsessive compulsive disorder, severe anxiety, and fibromyalgia and pain syndromes.
Stephen P. Levine, founder of Actify, said his clinics will likely offer the new therapy alongside the old. “We’ve been anticipating this for the last eight years,” he said. “Even though we’ve been delivering ketamine for a long time now, we certainly see the value in the FDA approved product and we will be providing it side by side.”
Levine said which patient gets which version of the drug will most likely boil down to practicalities: the FDA-approved esketamine will likely be covered by insurance policies, making it more cost-effective from the perspective of the patient. “Scientifically and realistically, they are extremely similar,” Levine said, adding that there will probably be some patients who have difficulty absorbing the nasal spray. “The decision will come down to what is the preferred route of administration, and whether there is a cost difference to the patients having one versus the other.”
Janssen Pharmaceuticals (JJ), 1125 Trenton-Harbourton Road, Box 200, Titusville 08560. 609-730-2000. www.janssen.com.
Actify Neurotherapies, 800 Bunn Drive, Suite 304, Princeton 08540. 609-955-4948. Steven P. Levine M.D., www.actifyneuro.com/princeton-nj.