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(00:05)
Attention deficit hyperactivity disorder, ADHD, is a chronic neurodevelopmental condition diagnosed by inattentive, hyperactive and impulsive behaviors. Clinical presentation also often includes associated features such as emotional dysregulation and executive dysfunction.
(00:29)
Dysregulation of key neurotransmitters is thought to contribute to these ADHD symptoms. In particular, the roles of norepinephrine, dopamine, and serotonin are interconnected playing roles in the wide spectrum of symptoms in ADHD. The interplay between these neurotransmitters contributes to the diverse presentation of symptoms patients may experience in everyday life. Most ADHD treatments target only one or two key neurotransmitters, typically norepinephrine, dopamine, or serotonin.
(01:09)
Simtriyo is a first-in-class triple reuptake inhibitor and CNS stimulant that targets norepinephrine, dopamine and serotonin transporters. The mechanism of action of Simtriyo in the treatment of ADHD is unclear.
(01:26)
However, its efficacy could be mediated through its activity as a norepinephrine-dopamine-serotonin reuptake inhibitor.
(01:45)
INDICATION and IMPORTANT SAFETY INFORMATION for SIMTRIYO® (centanafadine) CIII
INDICATION
Simtriyo is a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older weighing at least 20 kg.
Limitations of Use
The use of Simtriyo is not recommended in pediatric patients younger than 6 years of age, because this pediatric subpopulation had a higher incidence of weight loss than pediatric patients 6 years of age and older, or in pediatric patients weighing less than 20 kg, because of a lack of data for this subpopulation and the risk of weight loss.
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL IDEATION AND BEHAVIORS IN PEDIATRIC PATIENTS AGED 6 YEARS AND OLDER.
Higher rates of suicidal ideation and behaviors occurred in Simtriyo-treated patients aged 6 to 12 years with attention-deficit/hyperactivity disorder (ADHD) than in placebo-treated patients. Closely monitor all pediatric patients for suicidal ideation and behaviors. Consider stopping Simtriyo in patients who experience emergent suicidal ideation and behavior.
WARNING: ABUSE, MISUSE, AND ADDICTION.
Simtriyo has a potential for abuse and misuse. Abuse of central nervous system (CNS) stimulants, including Simtriyo, can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Simtriyo, can result in overdose and death. Before prescribing Simtriyo, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of Simtriyo, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Contraindications: Simtriyo is contraindicated in patients with a known hypersensitivity to centanafadine or any of the excipients of Simtriyo, taking or within 14 days of stopping a monoamine oxidase inhibitor, or with pheochromocytoma or a history of pheochromocytoma.
Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
Increased Blood Pressure and Heart Rate: Assess heart rate and blood pressure following increases in dosage, and periodically while on therapy.
Psychiatric Adverse Reactions: If new psychotic or manic symptoms occur, consider discontinuing Simtriyo.
Hypersensitivity Reactions: Serious hypersensitivity, including anaphylaxis and angioedema, have been reported. If a clinically significant hypersensitivity reaction occurs, immediately discontinue Simtriyo and initiate appropriate therapy.
Long-Term Suppression of Growth in Pediatric Patients: Closely monitor height, body mass index and linear growth in pediatric patients. Consider treatment interruption in patients not growing or gaining height or weight as expected.
Peripheral Vasculopathy Including Raynaud’s Phenomenon: Carefully assess for digital changes during Simtriyo treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
Serotonin Syndrome: Use of Simtriyo with other serotonergic drugs may cause serotonin syndrome. If occurs, discontinue Simtriyo and/or concomitant serotonergic drug.
Motor and Verbal Tics and Worsening of Tourette’s Syndrome: Regularly monitor patients for the emergence or worsening of tics or Tourette's syndrome. Discontinue Simtriyo if clinically appropriate.
Most commonly observed adverse reactions (≥5% and greater than placebo):
The most common adverse reactions in pediatric patients (aged 6 to 12 years) were rash and decreased appetite, and (aged 13 to 17 years) decreased appetite, nausea, rash, headache, and abdominal pain. The most common adverse reactions in adults were headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea.
Pregnant women exposed to Simtriyo and healthcare providers are encouraged to contact the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/
To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNINGS.
Attention deficit hyperactivity disorder, ADHD, is a chronic neurodevelopmental condition diagnosed by inattentive, hyperactive and impulsive behaviors. Clinical presentation also often includes associated features such as emotional dysregulation and executive dysfunction.
(00:29)
Dysregulation of key neurotransmitters is thought to contribute to these ADHD symptoms. In particular, the roles of norepinephrine, dopamine, and serotonin are interconnected playing roles in the wide spectrum of symptoms in ADHD. The interplay between these neurotransmitters contributes to the diverse presentation of symptoms patients may experience in everyday life. Most ADHD treatments target only one or two key neurotransmitters, typically norepinephrine, dopamine, or serotonin.
(01:09)
Simtriyo is a first-in-class triple reuptake inhibitor and CNS stimulant that targets norepinephrine, dopamine and serotonin transporters. The mechanism of action of Simtriyo in the treatment of ADHD is unclear.
(01:26)
However, its efficacy could be mediated through its activity as a norepinephrine-dopamine-serotonin reuptake inhibitor.
(01:45)
INDICATION and IMPORTANT SAFETY INFORMATION for SIMTRIYO® (centanafadine) CIII
INDICATION
Simtriyo is a norepinephrine-dopamine-serotonin reuptake inhibitor and central nervous system stimulant indicated for the treatment of ADHD in adults and pediatric patients 6 years of age and older weighing at least 20 kg.
Limitations of Use
The use of Simtriyo is not recommended in pediatric patients younger than 6 years of age, because this pediatric subpopulation had a higher incidence of weight loss than pediatric patients 6 years of age and older, or in pediatric patients weighing less than 20 kg, because of a lack of data for this subpopulation and the risk of weight loss.
IMPORTANT SAFETY INFORMATION
WARNING: SUICIDAL IDEATION AND BEHAVIORS IN PEDIATRIC PATIENTS AGED 6 YEARS AND OLDER.
Higher rates of suicidal ideation and behaviors occurred in Simtriyo-treated patients aged 6 to 12 years with attention-deficit/hyperactivity disorder (ADHD) than in placebo-treated patients. Closely monitor all pediatric patients for suicidal ideation and behaviors. Consider stopping Simtriyo in patients who experience emergent suicidal ideation and behavior.
WARNING: ABUSE, MISUSE, AND ADDICTION.
Simtriyo has a potential for abuse and misuse. Abuse of central nervous system (CNS) stimulants, including Simtriyo, can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including Simtriyo, can result in overdose and death. Before prescribing Simtriyo, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of Simtriyo, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Contraindications: Simtriyo is contraindicated in patients with a known hypersensitivity to centanafadine or any of the excipients of Simtriyo, taking or within 14 days of stopping a monoamine oxidase inhibitor, or with pheochromocytoma or a history of pheochromocytoma.
Risks to Patients with Serious Cardiac Disease: Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
Increased Blood Pressure and Heart Rate: Assess heart rate and blood pressure following increases in dosage, and periodically while on therapy.
Psychiatric Adverse Reactions: If new psychotic or manic symptoms occur, consider discontinuing Simtriyo.
Hypersensitivity Reactions: Serious hypersensitivity, including anaphylaxis and angioedema, have been reported. If a clinically significant hypersensitivity reaction occurs, immediately discontinue Simtriyo and initiate appropriate therapy.
Long-Term Suppression of Growth in Pediatric Patients: Closely monitor height, body mass index and linear growth in pediatric patients. Consider treatment interruption in patients not growing or gaining height or weight as expected.
Peripheral Vasculopathy Including Raynaud’s Phenomenon: Carefully assess for digital changes during Simtriyo treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
Serotonin Syndrome: Use of Simtriyo with other serotonergic drugs may cause serotonin syndrome. If occurs, discontinue Simtriyo and/or concomitant serotonergic drug.
Motor and Verbal Tics and Worsening of Tourette’s Syndrome: Regularly monitor patients for the emergence or worsening of tics or Tourette's syndrome. Discontinue Simtriyo if clinically appropriate.
Most commonly observed adverse reactions (≥5% and greater than placebo):
The most common adverse reactions in pediatric patients (aged 6 to 12 years) were rash and decreased appetite, and (aged 13 to 17 years) decreased appetite, nausea, rash, headache, and abdominal pain. The most common adverse reactions in adults were headache, decreased appetite, insomnia, nausea, dry mouth, and diarrhea.
Pregnant women exposed to Simtriyo and healthcare providers are encouraged to contact the National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or visiting https://womensmentalhealth.org/research/pregnancyregistry/adhd-medications/
To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 (www.fda.gov/medwatch).
Please see FULL PRESCRIBING INFORMATION, including BOXED WARNINGS.
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