Spravato - Advanced Psychiatry Inc

Studied in adults with treatment-resistant depression*

Taken with a daily oral antidepressant

Nasal spray you self-administer under the supervision of a healthcare professional

Tell your doctor if you have a history of drug or alcohol abuse

After 16 weeks of therapy, those patients who stayed on SPRAVATO™‡ did better than those who stopped therapy

Greater reduction of depression symptoms at four weeks† (compared to those who received a placebo and oral antidepressant)

After you take SPRAVATO™, a healthcare professional will monitor you for at least two hours during the observation period for possible side effects. More About Side Effects

*In clinical trials, treatment-resistant depression was defined as adults who are currently struggling with major depressive disorder and who have not responded adequately to at least two different antidepressants of adequate dose and duration in the current episode.

†In clinical trials of adults who took SPRAVATO™ and an oral antidepressant compared to those who received a placebo and an oral antidepressant. Based on an overall score on a standardized rating scale.

‡Along with an oral antidepressant.

SPRAVATO™ Side Effects

Serious side effects include sedation, dissociation, abuse, increased risk of suicidal thoughts and actions, increased blood pressure, problems with thinking clearly and bladder problems. The most commonly observed side effects in adults taking SPRAVATO™ and an oral antidepressant for treatment‑resistant depression were:

§Dissociation was reported in two ways in the clinical studies: through adverse event reports (41% of patients) and by using a standardized scale (61%–75% of patients).

‖Sedation was reported in two ways in the clinical studies: through adverse event reports (23% of patients) and by using a standardized scale (49%–61% of patients).

SPRAVATO™ Dosing

SPRAVATO™ is taken with a daily oral antidepressant
You administer SPRAVATO™ nasal spray yourself under the supervision of a healthcare professional at a certified SPRAVATO™ treatment center
SPRAVATO™ is taken twice a week for the first four weeks
After the first four weeks, SPRAVATO™ is taken once a week for a month
After this, SPRAVATO™ is usually taken either once a week or once every two weeks

SPRAVATO™ Safety and Tolerability

SPRAVATO™ nasal spray was evaluated for safety in both short- and long-term clinical trials of adults diagnosed with treatment-resistant depression.
Do not take SPRAVATO™ if you have a blood vessel disease (aneurysm), an abnormal connection between your blood vessels (arteriovenous malformation), a history of bleeding in the brain or are allergic to esketamine, ketamine or any of the ingredients in SPRAVATO™. Talk to your doctor to learn more.

How Is SPRAVATO™ Different?

How oral antidepressants work

Today’s most commonly used oral antidepressants are thought to treat depression by increasing levels of neurotransmitters (serotonin, norepinephrine and dopamine) in areas of the brain that affect mood.

How SPRAVATO™ may work differently

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. SPRAVATO™ is taken with a daily oral antidepressant.

Frequently Asked Questions

How do oral antidepressants work?

Oral antidepressant medications commonly used today are thought to treat depression by increasing levels of neurotransmitters (serotonin, norepinephrine and dopamine) in areas of the brain that affect mood.

How does SPRAVATO™ work differently?

How were the safety and benefits of SPRAVATO™ studied?

The safety and benefits of SPRAVATO™ nasal spray, given with an oral antidepressant, 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™, both short-term and long-term for up to one year, for treatment‑resistant depression.

Can I be treated with SPRAVATO™ for depression during pregnancy or while breastfeeding?

No, treatment with SPRAVATO™ is not recommended during pregnancy or while breastfeeding. You should let your doctor know if you are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed. If you are a woman planning to start SPRAVATO™, and are of childbearing age, you should use highly effective contraception while taking SPRAVATO™. Talk with your doctor about methods of birth control that should be used.

If you become pregnant while being treated with SPRAVATO™, you should talk to your doctor as soon as possible about discontinuing treatment and about other options for treating your depression.

Is SPRAVATO™ right for you?

If you’ve struggled with depression and tried two or more antidepressants^¶ in your current episode without adequate relief, talk to your doctor to see if you have treatment-resistant depression.

Ask your doctor if SPRAVATO™ may be an option for you.

After Treatment

A healthcare professional will monitor you for at least two hours. You won’t be able to drive or operate machinery that requires you to be completely alert until the next day, following a restful sleep. So you’ll need to plan for rides on treatment days.

Preparing for Treatment

The SPRAVATO™ treatment plan. A different treatment experience

SPRAVATO™ is a prescription medicine, used along with an antidepressant taken by mouth, for treatment-resistant depression (TRD) in adults.

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.

It is not known if SPRAVATO™ is safe and effective in children.

What is the most important information I should know about SPRAVATO™?

SPRAVATO™ can cause serious side effects, including:

Sedation and dissociation.

SPRAVATO™ may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation).

Abuse and misuse

There is a risk for abuse and physical and psychological dependence with SPRAVATO™ treatment. Your healthcare provider should check you for signs of abuse and dependence before and during treatment with SPRAVATO™.

SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS)

Because of the risks for sedation, dissociation, and abuse and misuse, SPRAVATO™ is only available through a restricted program called the SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO™ can only be administered at healthcare settings certified in the SPRAVATO™ REMS Program and to patients enrolled in the program.

Increased risk of suicidal thoughts or actions.

SPRAVATO™ may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions?

Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions.
Tell your healthcare provider right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.