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FDA Approves Johnson & Johnson's Nasal Spray Antidepressant | INN

09 March 2019

The Anxiety and Depression Association of America, based in Silver Spring, Maryland, urged the FDA's approval to address what has been called one of psychiatry's most glaring problems.

A variant of the party drug Ketamine has been licensed in the USA for treatment-resistant depression.

The approval of nasal spray esketamine marks the first new type of treatment for depression in more than 30 years and has raised hopes for its relatively fast action and ability to treat some otherwise unreachable patients.

The anti-depressants available at present of the likes of Eli Lilly and Co's Prozac impact the neurotransmitters - serotonin and norepinephrine.

The new treatment, which is called Spravato (drug name esketamine) is a nasal spray that is meant to influence the NMDA receptor in the brain that has been linked to depression.

It's only for patients who have tried at least two other medications for depression without success, so not every patient can get it. Esketamine and ketamine work by targeting glutamate, unlike now used antidepressants that target serotonin, and doctors were already using ketamine off-label to treat depression, according to the AP. 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. Given in low doses through infusions, he says Ketamine is safe and effective.

This could be fantastic news for a third of those who suffer major depressive disorders and who don't respond to existing therapies and it will only be administered to those for whom the existing treatments don't work. Gerard Sanacora, a psychiatrist and the director of the Yale Depression Research Program said in a statement, "I have no doubt in my mind that this is a very useful treatment". Even so, doctors can legally prescribe it for off-label medical uses. Johnson & Johnson is hopeful that this drug will be approved by hundreds of centers within the first year.

"Substantially different agents are only rarely appearing from pharmaceutical companies or other laboratories", said Dr. Paul Summergrad, a psychiatrist at Tufts University. The FDA said users should be monitored by a health care provider for at least two hours after receiving Spravato.

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

The drug will be administered at clinics under supervision.

Spravato was developed by a group of researchers who discovered that ketamine has a rapid antidepressant effect.

Some doctors plan to offer both ketamine and the new J&J drug. It has been slated to cost around $885 (£673) per treatment.

FDA Approves Johnson & Johnson's Nasal Spray Antidepressant | INN