SPRAVATO

How Does It Compare?

Learn About Spravato
and The Restore Ultra-Rapid Infusion Difference...

Choose Which Is Best For You

SPRAVATO™ (esketamine) is a ketamine-based medication that was recently approved by the FDA for the treatment of depression. Spravato is to be used in combination with antidepressant pills for difficult-to-treat depression. That is, depression which has not improved despite several back-to-back trials of different antidepressants.

How is Spravato (esketamine) related to ketamine?

Spravato (esketamine) is one of two identical molecules that comprise the 50-year-old anesthetic ketamine. Ketamine is composed of two identical molecules that bend light in different directions. One molecular bends light to the right and is called arketamine and the other bends light to the left and is called esketamine.

Esketamine has some effects which are similar to ketamine and other that are not. Esketamine is a fast-acting anesthetic like ketamine - but is less effective as an anti-depressant than ketamine.

 

How well does Spravato work compared to other popular antidepressants?

Traditional antidepressant medications can take up to 2 – 4 weeks to take effect. Several weeks can be a long time to wait for an improvement in symptoms, especially if the antidepressant causes side effects such as nausea, stomach upset, dry mouth, sleeplessness or drowsiness––which many do. Add to that frustration the fact that 60% – 70% of sufferers will not respond to the first treatment they try.

The main benefit of Spravato esketamine is that it causes a fast––within hours and days––improvement in the symptoms of depression. This is a major shift in treatment options for sufferers who could feel that they are running out of options. But, Spravato has only been studied in four fairly small phase III FDA trials, three of which lasted only four weeks. The results were decidedly mixed, and some scientists have pointed out that the FDA relaxed its usual rules for accepting drugs, in order to let it through. Some scientists do not believe that esketamine is as effective as the parent molecule ketamine.

“I didn’t find the evidence persuasive,” says Julie Zito, professor of pharmacy and psychiatry at the University of Maryland. “They evaluated the efficacy using symptom score change and there was only a three- to four-point improvement on a 60-point scale, which you have to say is very modest.”

How is Spravato Administered?

Spravato is given by a special nasal spray in the doctor’s office. The nasal spray helps Spravato get absorbed faster than taking a pill. It is given twice a week for the first month, and then once a week for one month and then every week or every other week after that. So, over the course of the first year, patients will require anywhere from 32 to 52 treatment sessions to maintain the benefit.

Spravato administration graph

Also, due to common potential side effects, you must remain in the doctor’s office for at least 2 hours after the nasal spray is given.
Adverse effects chart

You also must have someone drive you home from the treatment center and may not drive for at least 12-24 hours after the treatment.

How much does Spravato (esketamine) nasal spray cost?

The cost of Spravato treatment will depend on the dose needed. The nasal spray helps esketamine get absorbed faster than taking a pill. It is given––in the doctor’s office––twice a week for the first month, and then every week or every other week after that.

Initial estimates for the cost of Spravato are between $590 and $885 per treatment for the medication alone. Because Spravato can only be administered in the doctor’s office under close supervision, added to the medication cost will be the cost of the 2-hour treatment session visit (about $250) –– so, each treatment session will cost between $840 and $1135 dollars.

Unfortunately, the costs can add up very quickly. Over the course of just 1 year, Spravato treatment which includes 32-52 maintenance treatment sessions, may cost $35,000 to $57,000 dollars.

 

Not All Ketamine-Based Treatments Are The Same...

Let’s look more closely at some of the differences between the two ketamine treatment options….

Compared to

restore ultra rapid 3 days


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How Does Spravato compare to a RESTORE Ketamine Infusion?

While Spravato is certainly a step in the right direction to rapid treat depression, there’s not a huge amount of evidence that it’s as effective as ketamine infusions in general. As we said, some scientists do not believe that esketamine is as effective treating depression as the parent molecule - ketamine.

In some preliminary studies, esketamine was only 30-40% as effective as standard ketamine on a milligram to milligram basis. That may begin to explain why the results of Spravato have been so modest. Another factor may be that the dose administered by the nasal spray is much less than that given by intravenous infusion and is not reliably or predictably absorbed.

Comparing the results obtained on standardized depression scales, intravenous ketamine infusions appear to be about 6X times more effective than Spravato. In addition, many fewer treatment sessions are needed for RESTORE as compared to Spravato.

RESTORE Advanced Ketamine Infusion, for example, only requires 3 sessions over three days to begin to work, while Spravato needs 12. Also, maintenance therapy is much easier with RESTORE. Just 3 additional infusions are need during the year to maintain the benefits while Spravato requires between 20-40 additional treatments.

Not only is RESTORE much more effective and efficient compared to Spravato, but it is also only a fraction of the cost. Over the course of 1 year of RESTORE treatment which includes a total of 6 treatment sessions, RESTORE costs $7,450 dollars compared to $35-$57,000 for Spravato.


ketamine picture

Description:  

The ketamine infusion most commonly used today was originally developed at the Yale University School of Medicine  in 1994.  In 1999-2000 it was discovered to be rapidly effective for the treatment of mood disorders such as depression, anxiety and PTSD.  It  has since become known as the standard ketamine infusion and used by the National Institute of Mental Health, major universities and ketamine centers throughout the world.

standard ketamine infusion series


Currently Used To Treat:

Depression      Bipolar Illness      Anxiety      PTSD

Standard Ketamine Infusion – Basic. 6 Infusions/14 Days Series Includes -

The Standard Ketamine Infusion includes all aspects of care as recommended by the American Psychiatric Association and the American Society of Anesthesiologists, this includes:

Initial Evaluation:
Comprehensive Initial screening and assessment.
Review of medical records, depression, anxiety and pain metrics.
Review of all prior laboratory tests and evaluations.
Comprehensive treatment plan including consultation with each patient and family members regarding infusion protocol and infusion experience.

Standard Ketamine Infusion:
Standard ketamine infusion – Yale-National Institute of Mental Health Protocol
Infusion with consideration of your current medications and body weight.

Monitoring:
Physician supervised -
RN/Staff present with continual visual and vital signs monitoring including:
Heart rate
EKG
Blood pressure
Pulse Oximetry

Meets all recommendations:
American Psychiatric Association-
A Consensus Statement on the use of Ketamine in the Treatment of Mood Disorders
American Society of Anesthesiologists-
Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists

Re-assessments:
Staff - Post infusion assessment

Post-Infusion Maintenance Therapy:
Patient generally do best with regular maintenance infusions scheduled monthly.

Maintenance Therapy:

Requires continued regular maintenance infusions - usually on a monthly basis
Patient generally do best with regular maintenance infusions scheduled monthly. This maintains the benefits achieve during the initial therapy.  Of course, if something happens such as a very stressful life circumstance or traumatic event, then additional subsequent infusions may be needed more frequently for a short time.

Advantages:

Simple – Standard amount of medication based on body weight - may vary slightly on occasion.
Effective – 20-50% of patients experience improvement in their symptoms.
Reduced Medication – Some patients may find they can reduce or discontinue prior medications that were not helpful.
More Common – Because the standard ketamine infusion is becoming more widely recognized as an effective treatment and more physicians are offering it, it may be available near you.

Disadvantages:

The initial time commitment (two weeks) can be a barrier. Also, the benefits are often only temporary, so you may require ongoing treatment each month which can become expensive for many people. There is also the possibility that with repeated monthly exposure to ketamine, over time you may develop increasing tolerance or resistance to the drug and lose the benefits.

Note - The standard ketamine infusion may not be significantly or consistently effective for the treatment of migraines, painful neuropathy, fibromyalgia, RSD/CRPS or other types of neuropathic pain syndromes.

Cost:

Total cost for initial assessment and 6 infusions -14-day treatment series – $2950.00 USD
Maintenance infusions are $450.00


The Restore Ultra-Rapid Infusion is uniquely different and a major advancement in ketamine infusion therapy.  By combining Precision Medicine and Personalized Care Restore can bring more rapid relief symptoms in just 3 days and provide long term improvement.

Restore is the most effective infusion


Also, coming soon...

restore ultra rapid 3 days


Restore picture

Description:

The Restore Ultra-Rapid Infusion is the most effective, efficient and rapid infusion therapy available.  It was developed over 15 years of clinical research to effectively treat a wide variety of medical issues in the most efficient manner possible.

We discovered in 2002, that successful infusion therapy must be custom tailored to the individual and the specific medical condition to achieve the best effect.  To do that, we spent years of clinical research determining the most effective dose and method for each specific condition.  But more than that, we also knew that each person responds to medication differently.  Because of that, we carefully consider current medications, each person’s basic metabolism and genetic profile to optimize each infusion for that individual patient.

More than that, we also employ a specialized environment to enhance the effectiveness of our infusions that include proprietary synergist medications and protocols during each infusion session for maximal effectiveness.  These factors allow us to accomplish in just 3 sessions what others may not be able to achieve with 6 or more infusions.  Not only that, the benefits of feeling better last much, much longer than those seen with the basic ketamine infusion.



Currently Used To Treat:

Mood Disorders:                         Chronic Pain:                         Has Been Helpful in:
Depression                                    Fibromyalgia                          IBS - Irritable Bowel Syndrome
Bipolar Illness                               Migraine Headaches            CFIDS - Chronic fatigue Syndrome
Anxiety                                           Neuropathy                            RLS - Restless leg Syndrome
PTSD                                              RSD/CRPS                             Pelvic Pain - Vulvodynia - Pudendal Neuralgia

Restore Ultra-Rapid 3-day Intensive Infusion Series Includes -

Initial Evaluation:
Comprehensive Initial screening and assessment:
Review of medical records, depression, anxiety and pain metrics.
Review of all prior laboratory tests and evaluations.

Also includes -
Review and optimization of critical metabolic issues including thyroid hormone levels, testosterone/estrogen levels, Vitamin D, B6 and B12 levels as necessary. Additional testing for acetyl-L-carnitine or ALCAR may also be recommended.
May also include Genecept Cytochrome P450 analysis and BDNF variant screen.
Comprehensive treatment plan including extensive consultation with each patient and family members regarding infusion protocol and infusion experience.

Infusion Series:
Restore Ultra-Rapid three-part sequential enhanced and optimized infusion

Each infusion is optimized to each patient's individual physiological and psychological response based upon pharmacokinetic parameters.

Also includes - 
Pre-Infusion analysis:
Genomic Profile: Infusion optimization per genetic profile, current medications, sex, adjusted body composition, and prior treatment history.
Pharmacokinetic Optimization: Each infusion is optimized based on computer modeling of blood level concentrations.
Pharmacodynamic Monitoring: Each infusion is continually monitored and adjusted based on psychological and physiological responses.
Synergistic Agents: Synergistic medications are used as indicated to increase the effectiveness and durability of basic ketamine.

Monitoring:
Physician always present with each patient:
Continual real-time monitoring, including
Heart rate and heart rate variability
EKG
Blood pressure
Pulse Oximetry

Also includes -
Proprietary Optimization Protocol:
Restore Adjuvant administration
Autonomic nervous system monitoring and assessment
Pharmacokinetic monitoring
Reassessment of pharmacokinetic profile and response
Continual, minute-to-minute infusion adjustments and modifications.
Intra-infusion cognitive reframing and enhancement.
Acoustic and visual modification and entrainment.
May also include EEG alpha/theta suppression surveillance rates/data adjustment.

Meets and exceeds recommendations:
American Psychiatric Association-
A Consensus Statement on the use of Ketamine in the Treatment of Mood Disorders
American Society of Anesthesiologists-
Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists

Re-assessments:
Post infusion assessment by attending physician

Also includes - 
Review of physiological and psychological response
Review of pharmacokinetic and Pharmacodynamic response
Spatial and Chromatic analysis of subjective infusion experience
Inter-Infusion re-evaluations and reassessments by the physician.

Post Infusion Maintenance:
Restore supplement oral suspension – enhances effectiveness and prolongs durations of improvements

Maintenance Therapy:

The fewest maintenance infusions are needed –
After the first 3 infusions, patients' generally require only 2-3 maintenance infusions. After that, the beneficial changes become even longer lasting and fewer if any infusions are needed. Of course, if something happens such as a very stressful life circumstance or traumatic event, then subsequent infusion may be needed for a short time.

Advantages:

Very Effective – 85% of patients’ experience improvement in their symptoms
Very Rapid – Only requires 3 infusions, given over 3 days to complete
Longer Lasting – Improvements last for months to years, no need for frequent maintenance infusions
More ComprehensiveRestore Ultra-Rapid Infusion is effective for many more conditions than the standard infusion
Cost Effective – Initial Series and maintenance infusions cost less over the first year of treatment than any other option.
Time Effective –Less time away from home and work
Reduced Medication – Most patients find they can reduce or discontinue prior medications that were not helpful.

Disadvantages:

Only available at the Ketamine Institute in Sarasota, FL at the present time.

Cost:

The total cost of the Restore Ultra-Rapid Infusion treatment is $3450-4950.00 USD
Once the initial therapy is completed and each person’s optimal response level is determined, the cost of the maintenance infusions is only $725-825.00.


Also, coming soon - Restore Advanced Infusion

That is the Restore Ultra-Rapid Infusion difference.


 

“The most important breakthrough in antidepressant treatment in decades”....

Thomas Insel, MD - Director, National Institute of Mental Health



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