FDA Approves New Use of SPRAVATO™ (esketamine) for Major Depressive Disorder and Acute Suicidal Behavior

The U.S. Food and Drug Administration (FDA) has approved a new medication for people suffering from depression and acute suicidal behavior — SPRAVATO™. This medication was originally approved only for treatment-resistant depression, though it can now be used for acute suicidal ideation or behavior without treatment-resistant depression. This change is due to its effectiveness in reducing depressive symptoms and suicidal thoughts.

While there are many options for treating depression, research continually pushes forward to develop new medications. Millions of men and women in the United States suffer from at least one major depressive episode during their lives.

Major depressive disorder, commonly called depression, can rule your life. While commonly misunderstood as “just being sad,” the symptoms of depression are complex and difficult to manage without help. Someone with major depressive disorder may suffer from:

• Pervasive feelings of sadness, hopelessness and worthlessness.
• Difficulty sleeping.
• Lack of energy.
• Difficulty concentrating and impaired memory.
• Anxiety.
• Changes in appetite.
• Physical pain, such as headaches.

Depression can also lead to suicidal thoughts, also known as suicidal ideation. While struggling with depression is incredibly difficult, there are ways to address this disorder. Medical professionals can help you treat depression with therapy, medication or a combination of the two. Medications commonly prescribed for depression include:

• Selective serotonin reuptake inhibitors (SSRIs): These types of medications are usually a frontline treatment option for someone suffering from depression. SSRIs help the body utilize serotonin, which is commonly referred to as a “feel-good chemical.”
• Serotonin-norepinephrine reuptake inhibitors (SNRIs): These are typically prescribed in cases in which SSRIs are unsuccessful. While SSRIs affect serotonin, SNRIs affect two chemicals in the body: serotonin and norepinephrine.
• Tricyclic antidepressants: Tricyclic antidepressants are another class of drugs for depression treatment. This type of medication is usually a consideration for patients who have not been successfully treated with SSRIs.
• Monoamine oxidase inhibitors (MAOIs): Monoamine oxidase inhibitors help treat depression by blocking the enzymes that break down certain chemicals, including dopamine, serotonin and norepinephrine. With more potential side effects, MAOIs are also typically considered when other medication classes have proven to be ineffective.

Every person’s experience with depression is unique, and it can take time to find the right treatment that works for you. You and your doctor may need to try a few different approaches before settling on a successful treatment plan. Often, a combination of approaches can be the answer.

SPRAVATO™ is a nasal spray. Following recent clinical trials, the FDA has approved esketamine nasal spray for a supplemental new drug application (sNDA). SPRAVATO™ nasal spray is the first approved drug that demonstrates evidence of reduced depression symptoms within the first 24 hours of use. Following two Phase 3 clinical trials, SPRAVATO™ is now approved for treating depressive symptoms in people with treatment-resistant depression and major depressive disorder with acute suicidal behavior.

The clinical trials demonstrated notable improvement in depressive symptoms in patients who were given SPRAVATO™ 84 mg twice-weekly for four weeks in combination with an oral antidepressant. The SPRAVATO™ FDA approval gives people struggling with major depressive disorder and acute suicidal behavior another treatment option that could work more effectively than previous medications.

What Is SPRAVATO™?

SPRAVATO™ is a prescription medication used in combination with an oral antidepressant to treat adults suffering from treatment-resistant depression. Below is more information on what to expect from this medication:

• How does it work? SPRAVATO™ targets a specific receptor — N-methyl-D-aspartate (NMDA), which is different from how oral antidepressants function. The exact way in which the nasal spray works is not yet understood.
• What is the dosage of SPRAVATO™? Your doctor will prepare your dose for you, but you will self-administer the medication under supervision at a SPRAVATO™ (esketamine) Treatment Center. During the first four weeks of treatment, you will take the nasal spray twice a week. After that, you will work with your doctor to determine your dosage schedule. Typically, the dose will drop to once a week for a month and then once a week or once every two weeks.
• What can you expect when taking SPRAVATO™? Anytime you are taking a new medication, you will want to know how it will affect you. Studies have shown that SPRAVATO™, in combination with an oral antidepressant, results in reduced symptoms over four weeks of therapy — more so than in patients who received a placebo and an oral antidepressant.
• Why SPRAVATO™? SPRAVATO™ (esketamine) offers you an option for treatment if your condition has not responded to two or more other antidepressants. For anyone struggling with major depressive disorder, SPRAVATO™ (esketamine) could be a part of their treatment plan.

SPRAVATO™ does have side effects, such as dissociation, dizziness, nausea, sedation and increased blood pressure. After you take the nasal spray, you will remain under your doctor’s supervision for two hours to ensure you tolerate the medication. Abstaining from eating two hours before taking SPRAVATO™ can help reduce the risk of nausea and vomiting.

If you need to drive to your treatment location, you will need to arrange for a family member or friend to take you. You will be unable to operate machinery until the day following your treatment.

What Is Risk Evaluation and Mitigation Strategy (REMS)?

As a part of the FDA’s approval of SPRAVATO™, the regulatory body requires prescribing physicians and patients to participate in a special program — Risk Evaluation and Mitigation Strategy (REMS). Enrolling in this program ensures patients are aware of the risks associated with this treatment. It involves four steps:

1. Step one. In the first step, you will read a guide on how to use the medication. You will also talk to your doctor about the risks of SPRAVATO™.
2. Step two. Next, you will have the opportunity to ask your doctor any questions you have about the medication and REMS.
3. Step three. This step will confirm you understand the benefits and risks of SPRAVATO™ and how to participate in the REMS program.
4. Step four. In the final step, you and your healthcare provider will fill out and sign a REMS patient enrollment form.

SPRAVATO™ (esketamine) Therapy Available From Principium Psychiatry in Manhattan

If you are struggling with major depressive disorder and have yet to find a treatment that works for you, SPRAVATO™ (esketamine) may be a good option for you. The new FDA-approved indication means this treatment option can help with both major depressive disorder and acute suicidal behavior. Principium Psychiatry in Manhattan is a SPRAVATO™ (esketamine) Treatment Center. The treatment providers at Principium are here to help you understand whether SPRAVATO™ is right for you.

Schedule a visit with us online, and we can evaluate your treatment options to provide insight on what steps to take next. If it makes sense to move forward with SPRAVATO™, we will walk you through the REMS process and guide you through the entire course of SPRAVATO™ (esketamine) therapy. Depression is incredibly difficult to live with, but we work to help our patients find the treatment that can change that and improve their well-being.