[ad_1]
For years, ketamine treatment clinics across the country have offered intravenous infusions as a fast-acting treatment for severe depression. But last week, the US Food and Drug Administration approved a version of ketamine, called esketamine, to do the same thing. What is the difference and what will it mean for newly interested patients?
Ketamine, sometimes known as the "Special K" party drug, is a compound of two mirror molecules. It has long been approved as anesthetic, is not protected by a patent and is widely used – which means that it will not bring much money back to a pharmaceutical company. Thus, Janssen patented the left side of the molecule, esketamine, and sent it via the FDA's approval system as a potential cash cow called Spravato, thus legitimizing the Use of ketamine for depression.
"We provide a non-label treatment that has the baggage of being recognized as a club drug," said Steve Levine, founder of Actify Neurotherapies, which runs 10 ketamine treatment clinics in the country. "We've gone from" we're delivering unlicensed horse tranquilizers "to" we're delivering FDA approved Spravato "and it's just easier to talk to people about it.
Nevertheless, the FDA approval for esketamine in the treatment of depression accompanies many warnings. The drug should be administered as a nasal spray, patients should take another antidepressant at the same time and it can only be administered to patients who have previously tried (unsuccessfully) two antidepressants before. In particular, people will not be able to recover Spravato from the local Rite Aid. Spravato will only be available in certified clinics.
Although Janssen, the maker of Spravato, has not yet officially announced what "certification" means, some psychiatrists have a long way ahead of the process. Lori Calabrese, a psychiatrist who offers ketamine treatments in her Connecticut clinic, is already certified because she contacted Janssen as soon as news of the approval was given. She had to complete an Assessment and Mitigation Strategy (REMS) program, which consisted of checking all her medical licenses and showing that her clinic had been approved by the Drug Enforcement Administration for distribution. controlled substances. The next day, Calabrese was informed that she was allowed to administer Spravato. (A Janssen representative was not available to comment.)
Doctors must order medication for a particular patient and recover it in a specialized pharmacy. The patient will self-administer the nasal spray in the doctor's office, stay in the office for two hours of monitoring, and then be brought home. The Spravato never leaves the establishment. "This is a treatment model that is very different from anything we've seen in psychiatry," adds Calabrese. Janssen told him that the first shipments of Spravato would be sent on March 18th.
The news of Spravato sparked a lot of excitement, but doctors point out that the requirement to take it nasally – rather than intravenously, which is the typical method in clinics – can make it less effective . With an intravenous infusion, all the medication is absorbed and the delivery is much more controlled, says Levine of Actify Neurotherapies. Although the nasal spray helps people who can not (or do not want) to take an intravenous, the process may seem a little more complicated, especially because some of the drug may drift into the throat and that It is more difficult to control how much will have. There is also evidence that nasal ketamine will be less effective than IV ketamine. Some studies have shown that over 70% of people who try intravenous ketamine feel better. this number is closer to 45% for nasal ketamine.
It's not cheap either. Ketamine treatments usually cost a few hundred dollars per infusion, but the expenses do not come from the generic drug, which is cheap, but from the time of the doctors and the clinic. In contrast, only Spravato can cost close to $ 900 per session, which would represent a monthly cost – at the two recommended sessions a week – of nearly $ 7,000, Stat News. The good news is that Spravato will be at least partly covered by insurance, which will significantly increase access, says Bryan Clifton, chief medical officer at Kalypso Wellness Centers, another ketamine treatment clinic. But as Calabrese points out, it will be difficult to determine how long insurance and labor costs will cover when the treatment alone costs more than the alternative, which already includes these costs.
For some, Spravato's approval is more a story about the failures of the medical industry than about good news about an exciting new treatment. "We are very happy to see that ketamine is widespread, but I am sorry that this free-of-charge basic medicine is of no interest as long as no one can find a way to make more money out of it." said Steven Mandel, who runs Los Angeles. "It's so exciting to see this treatment approved publicly by traditional institutions, but it's one of the worst parts of our medical system that this drug has been despised by all the big companies until they can find a way to take part in the action ".
Erik Messamore, a professor of psychiatry at Northeast Ohio Medical University, agrees. Messamore – who previously worked with patients suffering from treatment-resistant depression – wanted to administer ketamine to a patient, but was informed that his insurer would not protect him from liability because the drug was not approved by the FDA. We did not need esketamine, he explains. We needed channels for regular ketamine to be accepted in clinical practice. Instead of waiting for Janssen's clinical trials, it would have been more useful for the American Psychiatric Association, the National Institutes of Health or another official body to issue guidelines encouraging the use of ketamine for this type of treatment.
That said, Messamore adds that while he was still working with severely depressed patients, he would absolutely propose Spravato. "I would pressure my administration to make it available to people as quickly as possible," he says.
[ad_2]
Source link