What is Spravato™ (esketamine)?
Spravato™ is the brand name for the prescription medication, esketamine, that is produced by Janssen Pharmaceuticals, Inc. The United States Food and Drug Administration approved Spravato™ in March 2019 for use in adults with treatment-resistant depression in conjunction with an oral antidepressant.
You are considered treatment-resistant when your depression doesn’t improve despite taking at least two antidepressants of adequate dose and duration. About 35% of adults taking antidepressants don’t respond to their medication.
Spravato™ is a nasal spray that is absorbed through the nasal lining and directly into your bloodstream. It is administered together with an oral antidepressant.
Spravato™ must be administered at a Spravato™ REMS certified health care center, such as Mindful Behavioral Health.
*Spravato™ is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if Spravato™ is safe or effective as an anesthetic medicine.
How does Spravato™ work?
Spravato™ targets the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently than currently available oral antidepressants. The exact way that Spravato™ works is unknown.
Most patients who experience improvement from Spravato™ describe that their symptoms improve within the first two weeks of treatment. During the clinical trials, most patients improved within the first 24-48hrs, with some patients needing four weeks of treatment before they got better.
Click on this link to watch a Spravato™ informational video: https://www.spravato.com/treatment-with-SPRAVATO
How can I receive Spravato™?
Patients interested in Spravato™ treatment must schedule a consultation at Mindful Behavioral Health. During the consultation, we will work on identifying if they are a good candidate for Spravato™ treatment. The requirements, at present, are to have a diagnosis of treatment-resistant depression and to be taking an oral antidepressant. Your insurance company may require other criteria.
How and for how long is Spravato™ taken?
Patients will administer Spravato™ nasal spray themselves under the supervision of a healthcare professional. Following this administration, the patient will stay for 2 hours so they can be monitored for side effects. Patients will need to plan for rides to and from our facility, as you should not drive or operate machinery until the day after a treatment session, following a restful sleep.
We provide our patients receiving Spravato™ with a comfortable and private room. Patients can bring a book, a relaxing playlist, or another form of entertainment for the session. In addition, a family member or companion can be present during the full time of treatment if they so desire.
Spravato™ is taken twice a week for the first four weeks. Then, the Spravato™ treatment dosing is adjusted to once a week for another four weeks. Some patients may be able to stop Spravato™ after the first eight weeks of treatment. However, during the clinical trials, patients who stayed on Spravato™ longer tended to do better than those who stopped the medication.
What are the most common side effects of Spravato™?
The most common side effects reported during the clinical trials for Spravato™ include dissociation (41%), dizziness (29%), nausea (28%), sedation (23%), reduced sense of touch and sensation (18%), anxiety (13%), lack of energy (11%), temporary increased blood pressure (10%), vomiting (9%) and the sensation of being drunk (5%). It is important to remember that these are not the only possible side effects, just the most commonly reported. Each patient's experience may be different. Because of the possibility of these side effects, patients must stay at our facility for 2 hours following Spravato™ treatment. For most patients, most if not all side effects will have subsided after 2 hours.
Because of the risk of side effects, we recommend that patients not eat or drink for 2 hours before receiving treatment with Spravato™.
During the Spravato™ clinical trials, less than 5% of patients discontinued treatment due to side effects.
How were the side effects of Spravato™ determined?
The safety and benefits of Spravato™ were studied in a clinical program involving short- and long-term trials, across more than 1,700 adult patients with treatment-resistant depression, that compared Spravato™ plus an oral antidepressant to a placebo nasal spray plus an oral antidepressant. These studies evaluated the efficacy and safety of Spravato™ in both short-term and long-term studies for up to one year.
Contact us to learn if you’re a good candidate for Spravato™.