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New drug offers hope to depression patients desperate for relief

South Florida Sun Sentinel - 3/15/2019

March 15-- Mar. 15--The newly FDA-approved drug for medication-resistant depression is coming to South Florida next week, bringing with it hope for millions of people who are desperate to get relief.

The drug, called esketamine, is a nasal spray that acts quickly to alleviate severe depression. Rather than taking weeks to kick in like most antidepressants, the nasal spray can give you relief from depression within hours -- a huge breakthrough for people who haven't responded to medication and are even at risk for suicide.

Medical experts are calling esketamine, marketed under the name Spravato, "the biggest advance for treating mental health in decades," and South Florida psychiatrists, hospitals and clinics are busily getting certified to start using it on patients.

"What's so exciting is if this takes off, it could help millions of people," said Dr. Daniel Bober, chief of the Department of Psychiatry at Memorial Regional Healthcare System in Hollywood.

Finding the drug locally should be relatively easy. Bober said he will start treating his patients in Hollywood with esketamine within weeks and already has private and hospital patients who want it. Manufacturer Janssen Pharmaceuticals Inc., a branch of Johnson & Johnson, said Spravato will roll out nationally on March 18.

The new drug has some trippy side effects, so patients are required to use it only in a doctor's office or clinic and be monitored for two hours after treatment. For example, the drug -- shortly after treatment -- could cause out-of-body and hallucinogenic sensations, dizziness, a drunken feeling, and increased blood pressure.

Still, Bober said his patients with depression who have tried every category of antidepressant available with no relief are eager to try this new option. Overall, about 30 percent of people with depression do not respond to traditional antidepressants, making it the leading cause of disability worldwide.

"The excitement is because this works for people who have shown to be treatment-resistant," he said.

Beware though: A squirt of this new spray comes with a hefty price tag. Janssen said a one-month course of treatment will cost between $4,720 and $6,785. Because Spravato is FDA-approved for depression as of March 5, however, insurance and Medicare may cover some or all of the cost.

While Spravato is new to the market, a relative of the drug has been around for decades. It is a derivative of the widely used anesthetic ketamine, which already has been available by intravenous treatments for depression at hundreds of clinics around the country, including about a dozen in South Florida. (With its trippy side effects, ketamine was at one time a popular club drug known as Special K.)

Doctors at South Florida ketamine IV infusion clinics plan to start offering patients the new nasal spray, too.

Dr. Francisco Cruz has operated ketamine clinics throughout South Florida for 2 1/2 years. His patients at Ketamine Health Centers get six initial IV infusions -- two a week for 40 minutes over a three-week period. Some patients require follow-up treatments. Cruz said his four clinics, which treat about 200 patients a month, charge about $600 per infusion, which is not covered by insurance because of the lack of FDA approval for this use.

"Many of our patients already had tried everything under the sun," he said.

Now, the doctors at the clinics will decide with each patient whether an IV infusion or the nasal spray -- or a combination of both -- will be most effective, not only with depression, but possibly also with Obsessive-Compulsive Disorder (OCD) and Post Traumatic Stress Disorder (PTSD). Cruz said just like with the infusions, some patients may need more doses of the nasal spray beyond the initial treatment.

"We know it's effective in the short term," Cruz said. "The struggle is how to extend those benefits. To reach transformational change, you also need therapy, exercise ... other things come into play to get where you need to be."

Madelin Manso is one of Cruz's patients in Coral Gables who wants to try the nasal spray. Manso said she has been getting ketamine infusions since 2017.

"I was in the worst depressed mood, not wanting to live. My first treatment worked within an hour," she said. "When I got up from the infusion, I was a different person."

After the first six rounds of treatments, Manso said she returns about every six weeks for a booster, or sooner if she feels depressive symptoms coming on. Before the infusions, Manso, 56, said she had tried all kinds of oral antidepressants since the age of 18 -- with no relief.

She recognizes that nasal spray, which while still pricey, could be covered by insurance and as effective. "I am totally happy with the infusions, but if I don't have to pay the high cost every six weeks, that would help a lot."

Although it may be covered by insurance, Dr. Bob Speth, Professor of Pharmaceutical Sciences at Nova Southeastern University'sCollege of Pharmacy in Davie, said he would like to see the cost of Spravato lowered.

Still, he see the advantages of a drug that absorbs quickly through the mucus membrane and believes the fast-acting nature of esketamine could help prevent suicides. Waiting several weeks for a traditional antidepressant to take effect is a "dangerous period" for someone who is depressed, Speth said. "If this new drug can act within hours to alleviate depression, that's a huge breakthrough."

Speth said he is cautiously keeping an eye on its outcomes. "Once it gets into widespread use, some effects may show up that were one in a thousand during the trials," he said.

Meanwhile, Janssen spokeswoman Kristina Chang said Spravato will available to only to doctors and clinics who get educated and certified on how to administer Spravato. "Our hope is to have hundreds of centers open within the first year across the country."

Where to get Spravato

Patients can visit SPRAVATO.com for a locator tool that will indicate where the newly approved nasal drug is available in their area.

Potential patients also may sign up to receive alerts when new treatment centers are available.

cgoodman@sunsentinel.com, 954-356-4661, on Twitter @cindykgoodman

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