Severely depressed patients will have a new, fast-acting treatment option after the U.S. approved a breakthrough drug that has the potential to upend how the condition is treated.
The Food and Drug Administration on Tuesday greenlighted Johnson & Johnson’s nasal spray Spravato, a close chemical cousin of the anesthetic ketamine that works quickly to alleviate symptoms of depression.
Spravato will cost $4,720 to $6,785 in the first month, and then decline in price to $2,360 to $3,540 monthly, J&J said in an email.
The approval of the first major breakthrough drug for depression since Prozac in 1987 could usher in a wave of new fast-acting treatments. Existing options typically take weeks to work, and aren’t effective for all patients. Companies like Sage Therapeutics Inc. and Allergan Plc are also testing depression drugs that work quickly.
“We’re working tirelessly here to ensure that we have resources available to support bringing treatment centers up to help patients with treatment-resistant depression because this is truly a devastating disease, and these patients have been waiting for quite some time for therapies to provide relief for them,” said Courtney Billington, president of J&J’s Janssen neuroscience division.
Medical centers that would like to administer the drug will have to be certified under J&J’s Risk Evaluation and Mitigation Strategies program. The product could be available within days at centers that complete the REMS certification and are properly equipped. J&J estimates that hundreds of centers could be ready to give the drug within the first year.
The certification safeguards have been put in place because ketamine is sometimes abused. Ahead of approval, a panel of experts weighed the abuse potential of ketamine, which at much higher doses is a party drug and can put users into a so-called K-hole in which they’re unable to interact with the world around them. In a report, agency staff called ketamine abuse “relatively uncommon,” with just 1.3 percent of people over age 12 abusing the drug, lower than the abuse rates for other hallucinogens like ecstasy and LSD.
The drug is also being tested in suicidal people. That data is expected later this year. Spravato was developed by J&J after a group of researchers discovered that ketamine, which was off-patent, had a surprisingly rapid antidepressant effect. Some of the first research showing that dates back to the 1990s, and that work was furthered by the National Institutes of Health before being developed into a pharmaceutical treatment by J&J.
Like many drugs to treat depression, it will come with a warning label that in some people, the medicine can increase suicidal thoughts during the first few months of treatment or if the dosage is changed.