Esketamine, the drug Johnson & Johnson received approval to sell, will appear under the brand name Spravato.
According to the FDA, trials of the spray demonstrated a "statistically significant effect compared to placebo on the severity of depression" with some effects noted within two days. More recently, some doctors have given ketamine to people with depression without formal FDA approval.
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.
Esketamine is created to be administered intranasally twice a week for an initial 4 weeks, in conjunction with a newly initiated oral antidepressant. Those drugs target the feel-good brain chemical serotonin, and can take weeks or months to kick in. Because ketamine can cause hallucinations and out-of-body experiences, the new drug must be administered in a clinical setting. It works nearly immediately. "Also, it seems to work in 24 to 48 hours, so there's a very rapid resolution of symptoms".
Johnson & Johnson said on Wednesday its nasal spray depression treatment, called Spravato, will be priced at $590 for a 56 mg dose and $885 for 84 mg.
"This offers hope, in capital letters", said Charney, who is a co-inventor on a patent on the use of ketamine as a depression treatment that has been licensed by Johnson & Johnson.
"This saved my life", Snow said.
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 drug can not be taken home for unsupervised use.
A clinical trial patient known as Robin P said the drug had a positive impact on him. "I close my eyes and my mind is amazingly quiet".
The approval of Spravato could potentially open the door for other types of antidepressant approvals in 2019, particularly in postpartum depression.
Government officials haven't suggested an explanation for the trend, though academic researchers point to the nation's widening income gap, financial struggles and divisive politics.
The drug will only be available through a restricted distribution system.
The FDA says the most common side effects of the drug observed in the trials included disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk. Additionally, all patients will be tracked in a registry to monitor long-term safety and effectiveness. But J&J will face competition in the marketplace. However, this does not provide a long term fix. Patients often pay hundreds or thousands of dollars for intravenous infusions of the drug over several weeks or months. Given in low doses through infusions, he says Ketamine is safe and effective.
The US Food and Drug Administration (FDA) has approved Spravato (esketamine), a new nasal spray medication for treatment-resistant depression.