FDA approves J&J's esketamine as faster-acting depression treatment

  • FDA approves J&J's esketamine as faster-acting depression treatment

FDA approves J&J's esketamine as faster-acting depression treatment

Approval of the drug, which will be sold by J&J as Spravato, gives a new treatment option for individuals who have previously failed two or more antidepressants, a population that is estimated to account for roughly a third of the 16 million adults in the USA who have had an episode of major depressive disorder.

The drug is to treat severe symptoms of depression, including adults with treatment-resistant depression (TRD). Like any new medication, it comes with many questions; clinical studies before FDA approval are limited in the number and type of patient they include, meaning that more information only comes to light when new drugs reach the "real world".

The FDA approval is a significant milestone not only for the company but for those living with MDD.

Spravato is the brand name under which Esketamine is expected to go on sale. All patients will be enrolled in the Spravato REMS registry to further characterize the risks of serious adverse outcomes from sedation, dissociation, abuse and misuse, and to support safe use of this medicine. Still, ketamine has always been explored as a potential treatment for depression due to its ability to relieve symptoms within hours. Critics are anxious, however, that the drug will have a high potential for abuse, like its cousin ketamine.

The agency added that Spravato nasal spray will be used along with a newly prescribed oral antidepressant, under supervision of health care professionals.

Since enrolling in a Spravato trial two years ago, Prothro says her depression has lifted and she's returned to hobbies she abandoned years ago, like gardening.

The US Food and Drink Administration (FDA) yesterday licensed the nasal spray for use by those who have already tried at least two medications for depression, without success.

In that trial, patients in stable remission on Spravato were 51% less likely to relapse compared to those who continued on a regimen of placebo plus oral antidepressant. Sage Therapeutics (NASDAQ:SAGE), for example, revealed in January that its drug, SAGE-217 met primary and secondary endpoints in a Phase 3 clinical trial to treat postpartum depression. "It will only be available in approved and certified treatment centers".

Johnson & Johnson said the wholesale cost of each treatment with ketamine will range from $590 to $885, depending on the dose.

The list price of a drug is not necessarily what patients actually pay.

The nasal spray has to be administered by doctors and monitored for a couple of hours afterwards to check for side-effects, but tests have shown that it can have a positive effect very quickly - sometimes within two days.