John Bacon | USA TODAY

AP

A new medication related to the iconic party drug "Special K" that can rapidly treat depression could revolutionize the treatment of the condition affecting more than 16 million Americans, experts say.

A subsidiary of Johnson & Johnson has won fast-track approval from the Food and Drug Administration for use of the drug esketamine combined with an oral antidepressant for adults who have tried at least two other treatment options without success.

Esketamine, administered as a nasal spray, is a cousin of the anesthetic ketamine, which was once a popular recreational drug. Studies have shown ketamine's effectiveness against depression, and ketamine clinics already operate across the nation.

Psychiatrist Steven Levine operates nine ketamine clinics nationwide to treat major depression, post-traumatic stress disorder and other conditions with intravenous "infusions."

He said the FDA approval will mean more patients will be willing to try the drugs – and that the new drug will be covered by insurance.

"This is an enormous deal in terms of access to care," Levine said. "And the degree of advancement can't be overstated. This is truly the best new option in over 60 years. And more will be coming down the pike."

Levine said he has treated more than 3,000 patients with ketamine at his Actify Neurotherapies clinics. But he said he expects to stock esketamine within months "happily coexisting" with the older drug.

AP

Jonathan Herbst, 42, says he has been battling depression for more than 20 years.

A financial services manager in Philadelphia, he began ketamine treatments in August – five or six treatments in the first two weeks, then one maintenance treatment every three or four weeks.

"It's been a lifesaver – literally I feel like it saved my life," Herbst said. "I lived my life carrying around a ton of bricks and suddenly that bag of bricks isn't there anymore."

The drug is not a panacea. The FDA warned that esketamine distribution will be tightly controlled due to the potential for abuse, suicidal thoughts and sedation along with possible problems with attention, judgment and thinking.

Demitri Papolos, associate professor of clinical psychiatry at the Albert Einstein College of Medicine in New York, says the new drug might not work as well as the old one. Papolos, who said he has been successfully treating patients with ketamine for a decade, said esketamine could also end up costing more than the generic ketamine.

"I am also afraid that if these drugs are hyped too much they will be overused," he said. "Ketamine is valuable for a specific form of mood disorder, not run-of-the-mill depression, in my experience."

Esketamine is for patients with "treatment-resistant depression," a major depressive disorder that at least two alternative antidepressant treatments failed to adequately address. Levine estimated that about half of the 16 million or more people who are treated for depression are treatment-resistant.

Tiffany Farchione is acting director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research.

"There has been a long-standing need for additional, effective treatments for treatment-resistant depression, a serious and life-threatening condition," she said.

Farchione said the agency reviewed controlled clinical trials of the drug before approving it. The spray may not be taken home; the patient self-administers Spravato nasal spray in a doctor’s office or clinic. Patients must be monitored by a health care provider for at least two hours after receiving their Spravato dose.

In a four-week clinical trial, the Spravato nasal spray demonstrated a "statistically significant effect" compared to a placebo, the FDA said, and some effect was seen within two days.

A longer-term trial showed treatment with Spravato plus an oral antidepressant provided "significantly longer time to relapse of depressive symptoms" than patients on a placebo.

The most common side effects in the clinical trials were disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity, anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.

The FDA approved ketamine as a general anesthetic in 1970. “Special K" emerged on the party scene years later, and ketamine became a controlled substance in 1999.