About Spravato

What is Spravato?

Spravato® is brand name for esketamine produced by Janssen Pharmaceutical Company of Johnson & Johnson. Spravato is only available in a nasal spray form, and only approved by the FDA for treating patients suffering from treatment-resistant depression (TRD).

Is Spravato right for me?

Spravato is FDA approved exclusively for adults suffering from Treatment Resistant Depression (TRD). Patients with treatment-resistant depression (TRD) may be a good candidate for Spravato treatments. TRD is a form of depression that doesn't improve with standard treatments such as antidepressants and therapy. It's typically defined as not responding adequately to at least two different antidepressant medications. To determine if Spravato is right for you, contact the team at Palo Alto Mind Body to discuss your specific situation and treatment options. Click here to contact us. 

Where do I get Spravato?

Although Spravato esketamine is administered as a nasal spray, people will not be permitted to purchase it for home use. To guard against abuse, patients will need to use Spravato under medical supervision at a clinic or doctor’s office that has been certified by the maker of Spravato as an authorized provider. Palo Alto Mind Body is a certified authorized provider of Spravato.

Do I qualify for treatment with Spravato?

Spravato is not for everyone. Spravato is only approved for adults suffering from Treatment Resistant Depression (TRD). To determine if you qualify, your doctor will work with you on the qualification process. Contact the team at Palo Alto Mind Body to discuss your specific situation, review the qualification requirements, and learn about treatment options.

How many Spravato treatments will I receive?

You will present twice a week for at least the first four weeks of treatment. After that, you may transition to weekly and then eventually every-other-week maintenance treatments depending on your provider's recommendation. Both Ketamine and Spravato require ongoing maintenance treatments to sustain your improvements. 

How should I prepare for my Spravato Treatment?

You should avoid eating for at least 2 hours before and drinking liquids for at least 30 minutes before Spravato treatments to reduce the chance of nausea and vomiting. We recommend wearing comfortable clothing and bringing headphones if you prefer to listen to your own music during treatment. Follow any specific instructions from your provider regarding adjustments to your medications. You should also arrange to have someone drive you home after treatment. And feel free to have a friend or loved one join you for company and support. 

What dose of Spravato will I receive?

The standard starting dose for Spravato is 56mg. From there, patients may be advised to advance their dosage to the maximum dose of Spravato 84mg. There are situations in which your provider may deviate from this dosing schedule based on your unique situation. Your provider will determine your recommended dosage based on factors such as how you are responding to treatments and how you are tolerating treatments.

Are Spravato treatments ongoing?

Maintenance treatments are often an essential part of ongoing care. That means for most patients, if they were to discontinue treatment, they would notice a return in symptoms. As such, there are two FDA-approved ongoing maintenance frequencies of weekly or every-other-week Spravato treatments. 

How do patients know if Spravato is helping or if the treatment is a good fit?

A provider will meet with you at each treatment to discuss how you are tolerating treatments and any changes you are noticing. We will also monitor your progress standardized, validated rating scales to measure the severity and improvement of your symptoms over time. Some patients report experiencing an abrupt and dramatic improvement in their symptoms, while others will experience cumulative, gradual changes over time.

Why is the observation period so long for Spravato?

Spravato nasal spray is only available through a restricted distribution program called Spravato REMS (Risk Evaluation and Mitigation Strategy). This program requires that patients be monitored by a healthcare provider for at least two hours after administration of the medication. Most patients feel back to normal by the end of this two hour period (or sooner) but some patients may require additional recovery time, which we can gladly accommodate.Spravato nasal spray is only available through a restricted distribution program called Spravato REMS (Risk Evaluation and Mitigation Strategy). This program requires that patients be monitored by a healthcare provider for at least two hours after administration of the medication. Most patients feel back to normal by the end of this two hour period (or sooner) but some patients may require additional recovery time, which we can gladly accommodate.

How is Spravato different from IV Ketamine?

Ketamine--like most chemicals--is made up of two different mirror-image molecules: S-ketamine and R-ketamine. Think of the S- and R- molecules like your left and right hands; that is, they are functionally similar but not exactly the same; rather, they are mirrors of each other. Spravato, the FDA-approved medication for depression, is the S-ketamine molecule, and its name is phoneticized as "esketamine" to make it more fluid to read in text. While Ketamine and Spravato are slightly different medications, both are effective for treating depression and other mental health and pain conditions.

Is Spravato or IV Ketamine better?

We often get the question: well, which one is better? It's not really a matter of better or worse; they're very similar. The main difference comes down to the politics of the drug approval process in the US. As discussed in another question above, Ketamine is approved by the FDA for the induction and maintenance of anesthesia. Because it's now a generic medication (it was first approved in 1970), no drug company would invest the one billion or so dollars it takes to get it approved for the treatment of depression. Instead, Janssen Pharmaceuticals (a division of Johnson & Johnson) worked on getting S-ketamine (Spravato) approved. Because S-ketamine is technically a "new" molecule in the eyes of the FDA, Janssen was able to secure a patent on the drug, thus protecting the hundreds of millions of dollars they invested to get it through the FDA process and bring it to market.

From a physician standpoint, we don't see medications through the financial lens of large drug companies, but it is the reality of the world in which we all live. The upside for our patients is that because Spravato is FDA approved for depression, almost all insurance companies will cover it, thus making it more accessible to those who need these advanced treatments for depression.

Why is the Spravato initiation schedule so different compared to infusions?

As an FDA-approved medication for treatment-resistant depression, Spravato has a defined treatment schedule. This includes an initiation phase of twice-weekly treatments for the first four weeks followed by ongoing weekly or every-other-week maintenance treatments. Your provider may recommend some deviation from this schedule depending on your situation and response to treatment. 

Because IV Ketamine is not FDA approved to treat depression, the guidelines for initiation and maintenance treatments are not as rigid. Our specific protocols are based on evidence-based research as well as many years of clinical experience. We typically recommend an initiation phase of 6-8 infusions in 2-3 weeks. From there, we gradually space out your maintenance interval by 1-2 weeks at a time to find a maintenance regimen that works best for you.

Is Spravato Addictive?

There is addictive potential with any controlled substance including Ketamine and Spravato. However, when these medications are used as prescribed and under the direct supervision of a provider, that risk is very low. It is also important to never combine Ketamine/Spravato with drugs such as alcohol, marijuana, or illicit substances.

Can Spravato treatments be administered at home or by myself?

No. Spravato is only FDA-approved for patient administration under the direct observation of a healthcare provider at a Spravato REMS certified facility. It is never dispensed directly to a patient for home use.

What are the potential side effects and risks of Spravato?

Call Palo Alto Mind Body to learn more about Spravato™. For additional information about Spravato™ from Janssen Pharmaceuticals, Inc., the maker of Spravato, visit www.spravato.com

Does my insurance cover Spravato?

Spravato was approved by the FDA in March 2019. It is expected that many insurance providers will begin offering coverage for qualified patients. As a first step, call your insurance provider to ask if they provide coverage for Spravato treatments. If you need additional help, call Palo Alto Mind Body and our team here, in conjunction with Janssen CarePath (the maker of Spravato™) will help you understand your insurance coverage and other possible affordability options.