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Efficacy and safety

The efficacy and safety of XELSTRYM for the treatment of ADHD in adults and pediatric patients 6 to 17 years was established in a study with XELSTRYM in pediatric patients and based on adequate and well-controlled studies of lisdexamfetamine in pediatric and adult patients.1

Patch

XELSTRYM provides a smooth onset of effect with low peak-to-trough variability1

Transdermal delivery demonstrated sustained levels of dextroamphetamine with a low daily dose of medication1

Mean Plasma Concentrations Versus Time Profile of Dextroamphetamine After a Single-Dose Administration of XELSTRYM and Lisdexamfetamine in Healthy Adults1

PK Curve
XELSTRYM1Lisdexamfetamine1
Single dose in adults18 mg/9 hours70 mg
Peak plasma concentration of dextroamphetamine (Cmax)44.6 ng/mL67.6 ng/mL
Area under concentration curve (AUCinf) of dextroamphetamine996 ng*h/mL1260 ng*h/mL
Medium time-to-peak concentrations (tmax)9 hours4 hours

PK study design1

Study design

After multiple dosing of 18 mg/9 hours of XELSTRYM with application site rotation in adults or 70 mg of lisdexamfetamine (simulated), Cmax of dextroamphetamine were 168.8 ng/mL and 184.5 ng/mL, respectively; AUC0-24 of dextroamphetamine were 1150 ng*h/mL and 1248 ng*h/mL, respectively.1

  • The amount of dextroamphetamine absorbed systemically is a function of both wear time and transdermal system size
  • Peak plasma levels of dextroamphetamine were typically reached at 6 to 9 hours after single application and 6 hours after repeat applications of XELSTRYM when worn up to 9 hours
  • Avoid exposing application site to direct external heat sources during wear because both the rate and extent of absorption are increased1

The long-term safety of XELSTRYM for the treatment of ADHD relies on information from adequate and well-controlled studies of lisdexamfetamine1

Clinical Trials Experience in Adult Patients With ADHD Treated With Lisdexamfetamine1
The most common adverse reactions
(incidence ≥5% and at a rate at least twice placebo)1
AnxietyDry mouth
Decreased appetiteInsomnia
DiarrheaNausea

In addition, in the adult population, erectile dysfunction was observed in 2.6% of males on lisdexamfetamine and 0% on placebo; decreased libido was observed in 1.4% of subjects on lisdexamfetamine and 0% on placebo.

Adhesion data

  • Based on a clinical study in adult subjects wearing XELSTRYM 18 mg/9 hours, 233 of 238 transdermal systems (98%) exhibited 75% or greater surface area adhesion at all timepoints evaluated (every hour) throughout the 9-hour wear period
  • In another study in which pediatric patients 6 to 17 years and adult patients wearing XELSTRYM 4.5 mg/9 hours or 18 mg/9 hours were not confined to the clinical unit, 50 out of 58 transdermal systems (86%) exhibited 75% or greater surface area adhesion at 9 hours; only 3 transdermal systems (5%) were reported as fully detached during the study

XELSTRYM: A patch with the efficacy you expect from dextroamphetamine

Significant improvement in ADHD symptoms vs placebo seen with XELSTRYM as observed in a pivotal study with pediatric patients (6 to 17 years)1
  • XELSTRYM showed a statistically significant separation from placebo in SKAMP†scores in patients in a laboratory classroom setting in Period 1 (the classroom day)*
    • Changes in the SKAMP total score are seen from pre-dose (-.5 hours) through 12 hours post-application
  • Apply XELSTRYM to the application site 2 hours before an effect is needed and remove within 9 hours after application

Least-Squares (LS) Mean SKAMP Total Score After Treatment With XELSTRYM or Placebo in Period 1 Classroom Day*

LS=least squares; SE=standard error.
*Period 1 was the first week of the two-week double-blind, placebo-controlled, crossover treatment phase.1
†SKAMP=The Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) total score, a validated 13-item rating scale to assess manifestations of ADHD in a classroom setting. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.1

Pediatric study design

Study design: Following a 5-week open-label, dose optimization phase with XELSTRYM (4.5 mg/9 hours, 9 mg/9 hours, 13.5 mg/9 hours, and 18 mg/9 hours), patients were randomized to one of two treatment sequences: 1) XELSTRYM (optimized dose) followed by placebo, each for one week, or 2) placebo followed by XELSTRYM (optimized dose), each for one week. The primary endpoint was to assess the efficacy of XELSTRYM vs placebo as measured by the SKAMP† Total Score in a modified analog classroom study.1

*Period 1 was the first week of the two-week double-blind, placebo-controlled, crossover treatment phase.1
†SKAMP=The Swanson, Kotkin, Agler, M. Flynn, and Pelham (SKAMP) total score, a validated 13-item rating scale to assess manifestations of ADHD in a classroom setting. Items are specific to place (classroom setting) and time (during a typical classroom period), and the scale is used to assess multiple ratings taken within a day.1

Most common adverse events with XELSTRYM in pediatric patients with ADHD

Adverse Reactions Reported by ≥2% of Pediatric Patients 6 to 17 Years With ADHD Receiving XELSTRYM and Greater Incidence Than Placebo in the Double-Blind Phase1
Adverse reactionXELSTRYM
All doses (n=105)		Placebo
(n=105)
Decreased appetite12%2%
Headache6%4%
Insomnia8%6%
Affect lability3%0%
Tic2%0%
Vomiting4%0%
Abdominal pain4%2%
Nausea3%1%
Irritability2%1%
Blood pressure increased2%1%
Heart rate increased2%0%

Application site reactions seen with XELSTRYM

  • No subject discontinued due to application site reactions1
    • During the wear time or immediately after removal of XELSTRYM, patients experienced pain, pruritus, burning sensation, erythema, discomfort, edema, and swelling
    • Patients who experienced discomfort and pain at the application site during the wear time reported resolution within 2 to 4 hours after XELSTRYM application
  • Application site reactions seen with XELSTRYM
    • During the dose-optimization phase (DOP), 73% of patients reported application site irritation; 72% of patients reported discomfort at clinic visit assessments
      • XELSTRYM 4.5 mg was the starting dose for all patients undergoing titration during the DOP and the majority of application site discomfort was reported at this starting dose
    • During the double-blind phase, 69% of patients reported any discomfort, 10% reported severe discomfort, and 94% of patients reported irritation at clinical assessments
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Reference: 1. XELSTRYM (dextroamphetamine) transdermal system, CII [package insert]. Miami, FL. Noven Therapeutics LLC. November 2022.

Important Safety Information
INDICATION AND LIMITATIONS OF USE

XELSTRYM (dextroamphetamine) transdermal system, CII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adult and pediatric patients 6 years and older. Pediatric patients younger than 6 years of age experienced more long-term weight loss than patients 6 years and older.

IMPORTANT SAFETY INFORMATION
WARNING: ABUSE, MISUSE, AND ADDICTION

XELSTRYM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including XELSTRYM, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout XELSTRYM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

CONTRAINDICATIONS
  • Known hypersensitivity to amphetamine products or other components in XELSTRYM. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed.
  • Use with monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including linezolid or intravenous methylene blue) due to increased risk of hypertensive crisis.
WARNINGS AND PRECAUTIONS

Risks to Patients with Serious Cardiac Disease: Avoid XELSTRYM use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac diseases. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Increased Blood Pressure and Heart Rate: CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric adverse reactions: Exacerbation of Pre-existing Psychosis : May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder : May induce a mixed/manic episode in patients. Prior to initiating XELSTRYM treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms : At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue XELSTRYM if symptoms occur.

Long-Term Suppression of Growth in Pediatric Patients: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height). Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected. XELSTRYM is not approved for use in pediatric patients below 6 years of age.

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants, including XELSTRYM, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation including rheumatology referral, may be appropriate for certain patients.

Serotonin Syndrome: Risk is increased when XELSTRYM is co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), and with CYP2D6 inhibitors. If it occurs, discontinue XELSTRYM and initiate supportive treatment.

Contact Sensitization: Use of XELSTRYM may lead to contact sensitization. Discontinue XELSTRYM if contact sensitization is suspected.

Application Site Reactions: During wear time or immediately after removal of XELSTRYM, local skin reactions such as pain, pruritus, burning sensation, erythema, discomfort, edema, and/or swelling were reported. Select a different application site each day to minimize skin reactions.

External Heat: Avoid exposing XELSTRYM to direct external heat sources during wear because both the rate and extent of absorption are increased.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating XELSTRYM, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor XELSTRYM-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate. CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥2% and greater than the rate for placebo) in pediatric patients 6 to 17 years treated with XELSTRYM were: decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, increased blood pressure, and increased heart rate.

Most common adverse reactions (incidence of ≥5% and a rate at least twice placebo) in adults treated with lisdexamfetamine were: decreased appetite, insomnia, dry mouth, diarrhea, nausea, and anxiety.

PREGNANCY AND LACTATION

XELSTRYM may cause fetal harm. Breastfeeding is not recommended during XELSTRYM treatment.

Please click here for full Prescribing Information, including BOXED WARNING.

Important Safety Information
INDICATION AND LIMITATIONS OF USE

XELSTRYM (dextroamphetamine) transdermal system, CII is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adult and pediatric patients 6 years and older. Pediatric patients younger than 6 years of age experienced more long-term weight loss than patients 6 years and older.

IMPORTANT SAFETY INFORMATION
WARNING: ABUSE, MISUSE, AND ADDICTION

XELSTRYM has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including XELSTRYM, can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing XELSTRYM, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout XELSTRYM treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

CONTRAINDICATIONS
  • Known hypersensitivity to amphetamine products or other components in XELSTRYM. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed.
  • Use with monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including linezolid or intravenous methylene blue) due to increased risk of hypertensive crisis.
WARNINGS AND PRECAUTIONS

Risks to Patients with Serious Cardiac Disease: Avoid XELSTRYM use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac diseases. Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage.

Increased Blood Pressure and Heart Rate: CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.

Psychiatric adverse reactions: Exacerbation of Pre-existing Psychosis : May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder : May induce a mixed/manic episode in patients. Prior to initiating XELSTRYM treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms : At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue XELSTRYM if symptoms occur.

Long-Term Suppression of Growth in Pediatric Patients: CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height). Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected. XELSTRYM is not approved for use in pediatric patients below 6 years of age.

Peripheral Vasculopathy, including Raynaud’s Phenomenon: Stimulants, including XELSTRYM, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation including rheumatology referral, may be appropriate for certain patients.

Serotonin Syndrome: Risk is increased when XELSTRYM is co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans), and with CYP2D6 inhibitors. If it occurs, discontinue XELSTRYM and initiate supportive treatment.

Contact Sensitization: Use of XELSTRYM may lead to contact sensitization. Discontinue XELSTRYM if contact sensitization is suspected.

Application Site Reactions: During wear time or immediately after removal of XELSTRYM, local skin reactions such as pain, pruritus, burning sensation, erythema, discomfort, edema, and/or swelling were reported. Select a different application site each day to minimize skin reactions.

External Heat: Avoid exposing XELSTRYM to direct external heat sources during wear because both the rate and extent of absorption are increased.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome: Before initiating XELSTRYM, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor XELSTRYM-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate. CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥2% and greater than the rate for placebo) in pediatric patients 6 to 17 years treated with XELSTRYM were: decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, increased blood pressure, and increased heart rate.

Most common adverse reactions (incidence of ≥5% and a rate at least twice placebo) in adults treated with lisdexamfetamine were: decreased appetite, insomnia, dry mouth, diarrhea, nausea, and anxiety.

PREGNANCY AND LACTATION

XELSTRYM may cause fetal harm. Breastfeeding is not recommended during XELSTRYM treatment.

Please click here for full Prescribing Information, including BOXED WARNING.