Johnson & Johnson’s Spravato gets FDA approval for treating depression

The drug is aimed at patients with severe depression who have shown resistance to two antidepressants they have tried.

The U.S. Food & Drug Administration (FDA) has recently granted approval for Spravato, the ketamine-derived nasal spray developed by Johnson & Johnson, to be used by treatment-resistant depression patients.

Sources with knowledge on the matter commented that being approved by the FDA means ketamine has enabled the development of the first materially new treatment for depression in decades. Based on early research conducted by the National Institutes of Health, specialized clinics have supposedly provided intravenous ketamine therapies for depression for many years on an off-label basis.

However, insurance companies do not cover unapproved treatment methods, sources mentioned, while psychiatrists are not used to providing IV infusions at their premises. These factors apparently encouraged Johnson & Johnson to begin developing and testing esketamine, a related molecule, which could win a new FDA approval and be offered more conveniently to patients.

The sources informed that Spravato is the company’s brand name for esketamine, which is three times more potent as compared to ketamine and can be administered in low dosages as a nasal spray.

Husseini Manji, Global Head of Neuroscience Therapeutics for Johnson & Johnson’s Janssen Research & Development division, stated that the company will try and make Spravato accessible to patients as much as possible.

Sources added that the drug has been developed for people suffering from depression who have tried two anti-depressant drugs but have experienced no improvements and will be sold by Janssen at a wholesale acquisition cost of $590 to $885 per treatment. Allegedly, the drug is also being tested by the company in people exhibiting high suicide risk.

For deterring the drug’s abuse and addressing safety concerns, Johnson & Johnson is instructing Spravato patients to administer the nasal spray to themselves at a certified facility under a healthcare professional’s supervision two times a week for one month, then once every week or every alternate week on a continued basis.