Ketamine, a drug once synonymous with the party scene, is now at the forefront of depression treatment. Recent trials for SPRAVATO show that esketamine, a compound molecularly similar to ketamine, works quickly and rapidly to reduce depression symptoms in patients. Even so, doctors emphasize this is not an elixir for psychiatric disorders, and most definitely is not for everyone.
SPRAVATO is currently approved in the United States for use in adults with treatment-resistant depression and can be prescribed to patients who have failed to respond to two or more antidepressant medications.
Depression is a widespread disorder affecting around 300 million people globally. Having a treatment for those who failed to respond to previous courses of action could mean these patients would be able to return to work, interact with their families and more importantly regain the functionality they lost to their illness.
Despite this good news, researchers behind the ASPIRE trial want to take the drug even further. Their new goal is to have the drug approved to treat patients with major depressive disorder who have active suicidal ideation with intent.
“This is a specific vulnerable subset of patients with major depressive disorder and is especially meaningful as these patients are commonly excluded from clinical trials,” said Dr. David Hough, Esketamine Compound Development Team Leader at the Janssen Research and Development LLC, who oversees the ASPIRE trials.
Traditional antidepressant medications take between six to eight weeks for patients to start feeling any of the positive effects. SPRAVATO has been noted to work in hours—in some cases as few as four. For extremely at-risk patients with suicidal intent, the difference between a few weeks and a few hours may be the difference between life and death.
Even in patients without suicidal intent, depression is unpleasant to say the absolute least. That being said, if SPRAVATO acts so fast, why not offer it to all patients? It doesn’t quite work like that.
“There is no such thing as a drug for everyone,” explained Dr. Cristina Cusin, a Harvard based psychiatrist who has been involved with esketamine trials in the past but was not involved with the most recent ASPIRE trials. “If you think of any medical condition, there is no such thing as a drug for everybody.”
In truth, there are a number of reasons why patients may think twice before seeking to try esketamine, with the current price perhaps being the most salient. According to Johnson & Johnson, the wholesale cost of each treatment would range from $590 to $885, which would add up to nearly seven grand for just one month of treatment, NPR reported.
“In Massachusetts we are working with local payers to figure out the coverage, because some insurers have agreed to cover it in other states, but that does not apply to patients here,”explained Cusin. “The situation is not clear at this point, but if no one is going to pay for it,it is unlikely that a patient is going to pay out of pocket for esketamine,” said Cusin.
If the price doesn’t get you, the procedure might be enough. At the moment, it is not effective for the drug to be an oral treatment. When taken orally, it’s bioavailability is very low due to high extraction from the liver. For this reason, esketamine is typically administered in a nasal spray, although it can be intravenous as well. However, this must be done under a doctor’s supervision in a medical setting. Patients must typically visit a hospital twice a week for a month at first, then weekly and every other week, with visits lasting between two and three hours at a time.
The ASPIRE I & II studies are the seventh and eighth Phase 3 studies on esketamine nasal spray, but in total there have been 28 different clinical trials on the drug over the last eight years. Additional studies can be expected in the future, including those on the use of SPRAVATO in adolescents with active suicidal ideation.
Original Article: https://www.forbes.com/sites/danadovey/2019/09/20/ketamine-depression-treatment-passes-another-trial-but-isnt-for-everyone/#4aed3e1e1604
