FDA Approves New Nasal Spray Drug That Can Help Fight Depression
Last Tuesday the Food and Drug Administration approved a new drug for treatment of depression that some see as a step forward in treating the condition.
Spravato, produced by Janssen Pharmaceutical Companies of Johnson & Johnson, comes in the form of a nasal spray that has been approved to be used by patients who have been unsuccessful in treating their depression through other antidepressants. According to Johnson & Johnson’s press release, “The medicine is administered as a nasal spray that is absorbed by the lining of the nasal passages and into the bloodstream.”
The drug has been shown to yield fast positive results, some patients feeling effects within hours as opposed to the much longer time frame of other common antidepressants, such as Prozac or Zoloft. This has been attributed to how the drug takes a different approach to the brain than traditional medications. Common antidepressants target the brain through Serotonin by blocking the brain’s reabsorption of it, increasing the brain’s serotonin levels which can ease a patient’s depressive symptoms. However, this new drug targets what’s called Glutamate, a different neurotransmitter, that this drug has shown can be targeted to create fast acting improvements in depressive symptoms.
Spravato’s source has caused some controversy. The drug is also known as Esketamine, according to the FDA, a chemical relative to the anesthetic drug Ketamine, which is abused as a party drug for its effects on the brain. To ease worry about the use of Ketamine-based treatment, Courtney Billington, president of Janssen Neuroscience, said, “The amount of active ingredient that’s in this product, it’s at a very, very low dose.” Even though it is a low dose, there are still restrictions on the administration of this drug.”
According to Dr. Tiffany Farchione, acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, “Because of safety concerns, the drug will only be available through a restricted distribution system and it must be administered in a certified medical office where the health care provider can monitor the patient.” The patient is not allowed to take the drug home with them as it is also a safety risk, as they do not want a ketamine-based drug available to the general public.
Associated side effects also contribute to these restrictions on the drug. Though various patients have reported positive effects, clinical trials of the drug yielded mixed results and there are many side effects that can come from its use. The FDA reported that the most common side effects from their clinical trials that could possibly affect patients were, “disassociation, dizziness, nausea, sedation, vertigo, decreased feeling or sensitivity (hypoesthesia), anxiety, lethargy, increased blood pressure, vomiting and feeling drunk.”
We will have to wait and see if those risks decrease as more patients are monitored trying Spravato.
The cost of this drug is still hard to pin down in these early days but a figure given to Jon Hamilton of NPR by Johnson & Johnson is that “the wholesale cost of each treatment with esketamine will range from $590 to $885, depending on the dose.” The FDA gave these same numbers to Cammy Harbison of Newsweek, adding that it “would likely be covered by insurance.” Being that this was only just approved, final pricing will most likely be determined at a later date.
Dr. Matthai Mammen, Global Head of R&D at the Janssen Pharmaceutical Companies of Johnson & Johnson, said that this new drug “has the potential to change the treatment paradigm and offer new hope to the estimated one-third of people with major depressive disorder who have not responded to existing therapies.” Dr. Mammen continues by saying that this new treatment is “a testament to Janssen’s heritage of advancing solutions in neuroscience to heal minds and improve health outcomes.”
For those interested in updates on this drug, you can follow them at www.spravato.com.