"Controlled clinical trials that studied the safety and efficacy of this drug, along with careful review through the FDA's drug approval process including a robust discussion with our external advisory committees, were important to our decision to approve this treatment". The drug is a nasal spray created to treat severe forms of depression that don't respond to other treatments.
Esketamine seems to help alleviate depression by acting on the NMDA/glutamate receptor, which is different from more recently popular antidepressants.
Courtney Billington, the President of Johnson & Johnson's Janssen neuroscience division said that they have worked relentlessly to ensure that they have available resources with them to help patients with severe depression and the patients who were awaiting a quicker solution to get relief. 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.
The US Food and Drug Administration approved Johnson & Johnson's new drug, which is believed to have fewer negative side effects than ketamine.
"The amount of active ingredient that's in this product, it's at a very, very low dose", Billington said. Up to 7.4 million American adults suffer from so-called treatment-resistant depression, which heightens the risk of suicide, hospitalization and other serious harm, according to the FDA.
Unlike ketamine, psilocybin and MDMA have no legal medical use.
A decades-old drug, ketamine is already used off-label to treat depression by some doctors. After receiving a Spravato dose, a patient must be monitored by a healthcare provider for at least two hours.
However, the panel members echoed concerns raised by FDA staffers regarding the increased risk of sedation, dissociation and higher blood pressure observed in the study. It did not, however, reveal the drug's list price.
The approval of the drug is the first major success since the arrival of a drug called Prozac that showed a ray of hope for fast-acting treatments in 1987.
But he hopes that doctors who are now using ketamine continue to do so. It has been slated to cost around $885 (£673) per treatment.
"This is going to bring in some standards, regulation and it's going to make it safer and more accessible to patients", said Levine, who serves as vice president of the American Society of Ketamine Physicians, a group representing doctors, nurses and others using ketamine for treating depression or other nonapproved uses.