J&J Releases First Modern Anti-Depressant in Decades; Gets FDA’s Approval

Henrietta Strickland
March 12, 2019

The United States Food and Drugs Administration (FDA) have approved for sale a new nasal spray containing Esketamine for the management of treatment-resistantdepression.

That means about 5 million of the 16 million people in the USA with major depression might benefit from esketamine, said Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson. Compared to many now available antidepressants that may take weeks or months to produce an effect, esketamine works within hours, according to The Washington Post.

Some experts say the trial results were not strong enough to warrant the approval at this point. The drug, a nasal spray that manufacturer Johnson & Johnson has branded Spravato, is a close chemical relation to ketamine, an anesthetic that is known for its heady effects on the brain.

The drug will carry a boxed warning that patients taking the drug are at risk for sedation and problems with attention, judgment, thinking, abuse, misuse, and suicidal thoughts and behaviors - the major concerns underlying the REMS. Companies like Allergan Plc Sage and Therapeutics Inc. are also testing depression drugs that can work quickly. The first research in this regard was dated back to 1990s when ketamine was used as an underground rave culture party drug for its ability to produce psychedelic or out-of-body experiences. In the longer study, patients whose conditions had stabilized and continued to take the nasal spray in conjunction with an oral antidepressant took a "statistically significant longer time" to relapse than patients who received a placebo nasal spray with their oral antidepressant.

"I think we need to be cognizant of not positioning [Spravato] as a wonder drug or as a panacea, because it's not", said Steven Meisel, system director of medication safety at Fairview Health Services in Minneapolis, Minnesota, in an interview with BioPharma Dive. The drug can not be taken home for unsupervised use.

The drug will cost between $590 and $885 depending on the dosage and before various insurance discounts and rebates. "It will only be available in approved and certified treatment centers". 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.

In an emailed statement, J&J said Spravato's list price is "generally comparable" with other specialty mental health drugs. During the first month, patients will be treated twice a week. People who take esketamine will have to be monitored for at least two hours after receiving a dose to guard against some of these side effects.

Other reports by Click Lancashire

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