New FDA approved depression treatment tested in South Carolina
MYRTLE BEACH, SC (WMBF) - The Food and Drug Administration recently approved a new treatment for severe depression.
The evidence federal regulators needed to make the move came from right here in the Palmetto State.
Janssen Pharmaceutical Companies of Johnson & Johnson has developed a nasal spray called Spravato, otherwise known as esketamine. Unlike a pill, it must be administered by a medical facility and the user must be supervised by a doctor at all times.
This drug has been studied for years at the Medical University of South Carolina, where it showed remarkable results in some cases.
Dr. Mark George, M.D., a professor of psychiatry at MUSC, worked with the clinic in the trial of esketamine, which some call the "cousin" to ketamine, a drug that was used illegally as the club drug "Special K."
Doctors said this new drug has the potential to offer relief to millions of patients who suffer from depression and have exhausted all other options. Spravato is aimed at people with treatment-resistant depression or those who have tried at least two other antidepressants without success.
About one-third of people with depression do not find relief with current treatments, according to George. He said Spravato is a last resort and is approved to be used in combination with an oral antidepressant.
“What they did (researchers) was take people who were depressed, and they started them on a new pill, so something like Prozac, and at the same time they started them on Spravato, or fake Spravato. So, it really was testing whether this thing added to another antidepressant starting out would get people depressed, un-depressed quicker,” George said.
Researchers said people who take Spravato can feel better in a matter of hours, instead of weeks, which George said can be a life-saving difference to someone with suicidal thoughts or tendencies. However, more research needs to be done.
“We’ve never had a nasal, a puff to treat depression. Plus, it works quite rapidly, so you can administer it to patients who are depressed and they will feel better within several hours. If you have depression and you take a medication like Prozac, you typically have to wait four to six weeks, so most of our treatments in depression have been relatively slow-acting,” George said.
Because of its strength, Spravato has to be administered in a controlled environment because the side effects can be severe, including drowsiness and blood pressure spikes.
George said there's not a lot of research on the long-term ketamine use and it has the potential to be abused. However, it can be a very useful tool in a suicidal crisis.
“So, if somebody comes into the emergency room and they just have been thinking about jumping off the bridge and they need help, right now they don’t really have anything that we can do that quickly gets them un-suicidal. You know, we can sit them in a hospital and then start them on meds, but it will take a week or two for those things to get in and start making any changes. So the beauty of this compound, even though it may be an opiate, is that it could get you un-suicidal quickly,” George said.
Some doctors are concerned about the cost of treatment. The estimated Spravato dosage is twice a week for a month. The wholesale cost of each treatment will range from $600 to $900.
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