TIt is expected to be decided in the coming weeks by the market, which would be the first major depression in the market. The psychiatry field is buzzing with excitement – and hesitation.
Esketamine – developed by Johnson & Johnson and delivered as a nasal spray – would be used in combination with oral antidepressants in patients with depression who have not responded to other drugs. Many experts have considered esketamine as an important option for patients in need of new treatments – especially because it could work faster than existing antidepressants.
An independent advisory committee convened by the FDA The panel of medical experts voted 14-to-2 that the benefits of esketamine outweigh its risks, which include blood pressure problems, the potential for misuse, and dissociation, a temporary mental state in which a person might become less aware of their surroundings.
"We're always weighing the risk balance in treatment. We swing, [esketamine] is definitely of value, "said Dr. Wendy Marsh, a psychiatrist and medical director of the Depression Specialty Clinic at UMass Memorial Medical Center.
But some experts are not convinced that there is enough data to show that esketamine is effective. And they say they want more details on the drug should be used in the long run.
"There's a split in academia. Some are more likely to be skeptical, "said Dr. Erick Turner, a psychiatrist at Oregon Health and Science University, who is the FDA advisory committee that recently evaluated the drug. (Turner did not take part in the panel
Johnson & Johnson submitted five Phase 3 studies on the drug: three-short term studies, one maintenance study, and one long-term safety study. Two of those turned up positive results. Antidepressant and intranasal esketamine have been established in an oral antidepressant and intranasal esketamine. After a month, roughly 70 percent of patients who received treatment compared to a placebo group. The researchers considered an improvement in the rate of success.
The other positive study is a maintenance-of-effect study, in which participants who responded to esketamine in one of the short-term studies were randomly assigned to either placebo. The FDA generally wants to see two successful studies for approval – but historically, withdrawal studies have not counted toward that total.
"The threshold has been two adequate and well-controlled trials. In this case, they only got one, "said Turner. "Based on that, I would have voted no," he added.
A spokesperson for Janssen – the subsidiary of Johnson & Johnson that developed the drug – pointed to the positive results that showed esketamine could have a significant effect on treatment-resistant depression in some patients.
"Janssen has a strong track record of bringing important medicines to the world," spokesperson Greg Panico said.
Julie Zito, a professor of pharmacy and psychiatry at the University of Maryland, was one of only two advisory members who voted "no" on the question of whether or not they would be better off. She said that she would like to see patients, patients, and the families of patients working together to keep tabs on possible side effects and how well the drug is working.
"Dr. Gerard Sanacora, a psychiatrist and the director of the Yale Depression Research Program, said," That's a good thing. Sanacora has been involved in many of the trials and has also served as a consultant to Janssen.
"This is gonna be the big question: How do we use this in the clinic?" Sanacora said. Janssen has said that esketamine would be given a week during the first month of treatment, then reduced to once a week. But psychiatrists say they still have questions about long-term treatment with esketamine, how long to keep a patient on the medication and what the risks of long-term use might be.
"I certainly would like to see these ongoing studies for treatment duration and frequency," said Marsh.
Another big concern among experts: the hype around esketamine. The drug is the chemical mirror of ketamine, a longtime anesthetic that can be abused recreationally at higher doses. In recent years, there has been a boom in the off-label use of ketamine as a treatment for depression and other mental health conditions. Dozens of clinics have opened up the world to treat patients with ketamine, which, unlike esketamine, must be administered intravenously. Patients are paying $ 350 to nearly $ 1,000 per infusion, and many get six rounds of treatment, or more.
"There's been a lot of hype about ketamine in general. … "It's this belief that it's this kind of miracle drug," Turner said. "That's what it's saying that esketamine works, he's worried it's going to be seen as superior to other drugs for treatment-resistant depression or as a therapy." can produce very rapid effects – two points That kind of hype, he said, can mean patients get their hopes up about the drug "to a degree that's unwarranted."
In Sanacora's role as a researcher, he has always heard that they can not know why they do not know it. He's concerned that excitement over esketamine might lead to antidepressants – or even as a cure.
"The danger is having it so positively portrayed," Sanacora said. "I've been around enough to know that it's not necessarily a condition that responds to miracle drugs."