WHAT YOU NEED TO KNOW:
- The Food and Drug Administration approved a new drug on Tuesday that will benefit people whose depression treatments with other drugs failed.
- The new drug Esketamine which comes in a nasal spray form will be administered together with an oral antidepressant and branded as Spravato.
- To make sure that the drug is used as needed, the drug will be administered in authorized treatment centers, and not taken home by patients.
The first new drug that can treat depression within hours since Prozac hit the market in 1988 had been approved by the FDA on Tuesday after experts voted for its approval.
Esketamine, a chemical cousin of the anesthetic and party drug ketamine, were proven by studies to help people with major depressive disorders who failed to respond to treatments with at least two other drugs.
The decision was due to the persistent need for additional effective treatments for life-threatening conditions such as treatment-resistant depression, says Dr. Tiffany Farchione, the acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.
Dr. Dennis Charney, dean of the Icahn School of Medicine at Mount Sinai in New York who agrees, said the drug offers a lot of hope for millions of people.
Its approval comes as more doctors have started prescribing a generic version of ketamine for depression since it was proven two decades ago in a study led by Charney that it could treat depression.
Developed by Johnson & Johnson, Esketamine will be administered as a nasal spray coupled with an oral antidepressant under the brand name Spravato.
Johnson & Johnson is taking steps to ensure that esketamine is only used as intended, due to its similarities to ketamine which both can cause sedation and hallucinations when taken in high doses, plus the fact that ketamine is popularly used as a party drug.
“Spravato will not be dispensed directly to a patient to take at home. It will only be available in approved and certified treatment centers where patients will inhale the drug under supervision once or twice a week,” says Courtney Billington, president of Janssen Neuroscience, a unit of Johnson & Johnson.
He also added that the prescribed dose would unlikely to produce side effects like hallucinations.
Regardless, FDA requires the pharmaceutical company a warning label that says patients “are at risk for sedation and difficulty with attention, judgment and thinking (dissociation), abuse and misuse, and suicidal thoughts and behaviors after administration of the drug.”
While research director Dr. Demitri Papolos of the Juvenile Bipolar Research Foundation says he is pleased with the approval of the drug, he still hopes that doctors currently prescribing ketamine continue to do so.
The wholesale cost of each esketamine treatment will range from $590 to $885, depending on the dose, excluding administration and observation costs, according to Johnson & Johnson. If taken twice weekly, treatments will cost certified centers at least $4,720 to $6,785 during the first month while succeeding weekly treatments will cost about half as much.