Arynta is a medicine used to treat attention deficit hyperactivity disorder (ADHD). ADHD is a common condition in children, and it also affects adults. ADHD affects how you pay attention, focus, and control your behavior. There are three types of ADHD: inattentive, hyperactive-impulsive, and combined. It is often diagnosed during the early school years when children have problems paying attention. Symptoms in adults often cause trouble at work or with relationships. Treatment may include behavioral therapy, medicines, therapy, and lifestyle changes such as regular exercise, sleep, and stress management.
How Does Arynta Work for ADHD?
The main ingredient in Arynta is lisdexamfetamine, a central nervous system (CNS) stimulant. It may work by increasing levels of natural brain chemicals, such as norepinephrine and dopamine. This improves attention, hyperactivity, and impulsiveness (acting without thinking).
How Do I Take Arynta?
Arynta is a liquid that is taken by mouth once a day in the morning, with or without food. If you take the dose in the afternoon, you may have trouble sleeping. Use the oral dosing syringe and bottle adapter that come with Arynta. Read the Instructions for Use for detailed directions about how to measure and take your dose.
When you first start taking Arynta, your health care provider may start you on a lower dose of it and increase your dose if needed based on your symptoms.
How Was Arynta Studied for ADHD in Children?
There were six clinical studies done in children and adolescents ages 6 to 17 with ADHD who took oral capsule or chewable tablet forms of lisdexamfetamine, the active ingredient in Arynta.
Study 1 compared three doses (30 mg, 50 mg, and 70 mg) of lisdexamfetamine to a placebo that contained no medicine in 290 children who were 6 to 12 years of age. The people in the study did not know if they were getting lisdexamfetamine or the placebo. All children had either combined type or hyperactive-impulsive type ADHD. The average age of children in the study was 9 years old, and 69% were male. Most were White (53%), 24% were African American, 17% were Hispanic, and fewer than 1% were Asian, American Indian, Alaska Native, Native Hawaiian, or other Pacific Islander.
Lisdexamfetamine or the placebo was taken every day in the morning. The study lasted four weeks. All children in the lisdexamfetamine groups started treatment with 30 mg every morning for the first week. Children in the 50 mg and 70 mg groups had their doses increase by 20 mg every week until they reached their assigned dose of 50 mg or 70 mg. The main goal of the study was to compare the change in the Total Score of the ADHD Rating Scale (ADHD-RS) according to parents and study investigators from baseline to the end of the study. The ADHD-RS contains 18 items about the symptoms of ADHD, including hyperactivity, impulsiveness, and inattention. A total score ranges from 0 (no symptoms) to 54 points (severe symptoms).
Studies 2 and 3 looked at classroom behavior in children who were 6 to 12 years of age with ADHD to look at their attention and behavior over a 13-hour period. This was done by using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale, with the studies looking at the change in the SKAMP scale from baseline to 13 hours. The scale looks at ADHD symptoms in a classroom setting, with a lower score showing an improvement in attention and behavior.
Study 4 compared three doses (30 mg, 50 mg, and 70 mg) of lisdexamfetamine to a placebo in 314 adolescents from13 to 17 years of age with ADHD. The average age of people in the study was 14.6 years old, and 70% were male. Most were White (79%), 15% were African American, and 15% were Hispanic. Lisdexamfetamine or the placebo was taken every day in the morning. All people in the lisdexamfetamine groups started treatment with 30 mg every morning for the first week. People in the 50 mg and 70 mg groups had their doses increased by 20 mg every week until they reached their assigned dose of 50 mg or 70 mg. The study lasted four weeks. The main goal of the study was to compare the change in the Total Score of the ADHD-RS from baseline to the end of the study.
Study 5 included 336 children ages 6 to 17 years of age with ADHD who had an ADHD-RS score of 28 or higher at baseline (moderate ADHD). The average age of children in the study was 10.9 years old. Lisdexamfetamine (30 mg, 50 mg, or 70 mg per day) was compared to a placebo and another ADHD medicine (active control group). The study lasted seven weeks. All children in the lisdexamfetamine groups were started on 30 mg once a day in the morning. During the first four weeks, the dose was increased until the optimal dose was reached based on efficacy (at least a 30% lowering of the ADHD-RS score) and side effects. During the last three weeks, the dose stayed the same (maintenance period). The main goal of the study was to compare the change in the Total Score of the ADHD-RS from baseline to the end of the study.
In Study 6, 236 children from Study 5 plus 40 more children (276 total) were treated with open-label lisdexamfetamine for at least 26 weeks. Open-label means they knew they were taking the medicine. After 26 weeks, they were evaluated for treatment response. Response was defined as a Total Score on the ADHD-RS of less than or equal to 22 and a Clinical Global Impressions-Improvement Scale (CGI-S) less than 3. The CGI-S is a 7-point scale that measures how serious the disease is. A score of 0 is normal and a score of 7 is the highest. People who had a treatment response were able to enter the medicine withdrawal part of the study. There were 78 children who continued taking their same dose of medicine and 79 children who were switched to a placebo for six weeks. The people in this part of the study did not know if they were getting lisdexamfetamine or a placebo. The main goal of the study was to compare treatment failures between the two groups. This was defined as a 50% or greater increase in the ADHD-RS Total Score and a 2-point or greater increase in the CGI-S score.
What Benefits Were Seen in Children?
In all of the clinical studies, all three doses of lisdexamfetamine were better than the placebo.
Studies 2 and 3 found that children taking lisdexamfetamine doses of 30 mg, 50 mg, or 70 mg had lower SKAMP scores compared to those taking the placebo. This means that children taking lisdexamfetamine saw a greater improvement in their ADHD symptoms in the classroom compared to those taking the placebo. These improvements were seen from 1.5 hours up to 13 hours after the dose.
Study 6 found that lisdexamfetamine at doses of 30 mg, 50 mg, or 70 mg every morning was effective for long-term treatment. There were fewer treatment failures in children taking lisdexamfetamine (15.8%) compared to the placebo (67.6%). There was a rapid return of ADHD symptoms when children were switched to the placebo.
Your results may differ from what was seen in clinical studies.
How Was Arynta Studied for ADHD in Adults?
There were three clinical studies done in adults ages 18 to 55 with ADHD who took oral capsule or chewable tablet forms of lisdexamfetamine, the active ingredient in Arynta.
Study 7 compared three doses (30 mg, 50 mg, and 70 mg) of lisdexamfetamine to a placebo that contained no medicine in 420 people. The people in the study did not know if they were getting lisdexamfetamine or the placebo. The average age of people in the study was 35 years old, 54% were male, and most were White (83%). Lisdexamfetamine or the placebo was taken every day in the morning. The study lasted four weeks. All people in the lisdexamfetamine groups started treatment with 30 mg every morning for the first week. People in the 50 mg and 70 mg groups had their doses increase by 20 mg every week until they reached their assigned dose of 50 mg or 70 mg. The main goal of the study was to compare the change in the Total Score of the ADHD-RS from baseline to the end of the study.
Study 8 looked at ADHD symptoms in a simulated workplace environment in 142 adults ages 18 to 55 years with ADHD over a 14-hour period taking lisdexamfetamine or a placebo. Activities and assignments were scheduled during the day, and a math test called the Permanent Product Measure of Performance (PERMP) was given, which measures attention in people with ADHD. The main goal of the study was to see how effective lisdexamfetamine was, compared to the placebo, based on PERMP scores.
In Study 9, 123 adults ages 18 to 55 years old with ADHD were treated with open-label lisdexamfetamine for at least 26 weeks. Open-label means they knew they were receiving lisdexamfetamine. After 26 weeks, they were evaluated for treatment response. Response was defined as a Total Score on the ADHD-RS of less than 22 and a CGI-S less than or equal to 3. People who had a treatment response were able to enter the medicine withdrawal part of the study. There were 56 adults who continued taking their same dose of lisdexamfetamine and 60 adults who were switched to a placebo for six weeks. The people in this part of the study did not know if they were getting lisdexamfetamine or a placebo. The main goal of the study was to compare treatment failures between the two groups. This was defined as a 50% or greater increase in the ADHD-RS Total Score and a 2-point or greater increase in the CGI-S score.
What Benefits Were Seen in Adults?
In the short-term studies in adults, 30 mg, 50 mg, and 70 mg doses of lisdexamfetamine were better than the placebo at lowering the ADHD-RS Total Score.
Study 8 found that adults taking lisdexamfetamine at doses of 30 mg, 50 mg, and 70 mg had improved attention at all time points based on PERMP scores, compared to those taking the placebo. This means that adults taking lisdexamfetamine saw a greater improvement in their ADHD symptoms in a simulated workplace environment compared to those on a placebo. These improvements were seen from two hours up to 14 hours after the dose.
Study 9 found that lisdexamfetamine was effective for medium- to long-term treatment of ADHD. There were fewer treatment failures in adults taking lisdexamfetamine (9%) compared to those that switched to the placebo (75%). Most of the people taking the placebo showed a return of their ADHD symptoms by two weeks after stopping lisdexamfetamine.
Your results may differ from what was seen in clinical studies.
How Long Does It Take to Work?
In clinical studies, on average, lisdexamfetamine started working by the first week of treatment in both children and adults. Based on parent ratings of children, improvements were seen within two hours of taking it and lasted up to 13 hours.
Talk to your health care provider if you or your child do not see improvements in ADHD symptoms, including improvement in attention, impulsiveness, or hyperactivity. Your health care provider may increase the dose of Arynta or prescribe a different medicine.
What Are Other Unique Considerations to Be Aware Of?
Arynta is a schedule II medicine, which means it has a high chance of addiction, abuse, and misuse. There is also a risk of you or your child relying on the medicine (physical dependence). Your health care provider will monitor you or your child while they're on Arynta. Do not share Arynta with others. Talk to your health care provider about any concerns you may have about this.
Keep Arynta in a safe, preferably locked place, and dispose of any unused medicine properly. You can dispose of any unused, expired, or remaining Arynta by a medicine take-back program that is offered by the Drug Enforcement Administration or by going to a DEA-authorized collection site. If no take-back program or authorized collection site is available, mix Arynta with dirt, cat litter, or coffee grounds, place it in a sealable plastic bag, and throw the bag away. Visit www.fda.gov/consumers/consumer-updates/where-and-how-dispose-unused-medicines for more information on how to dispose of unused medicines.
What Types of Interactions Can Happen?
Arynta should not be taken with a monoamine oxidase inhibitor (MAOI) or within 14 days of stopping an MAOI, as this can increase the risk of extremely high blood pressure (hypertensive crisis). These medicines can include isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), selegiline (Emsam), and tranylcypromine (Parnate).
Arynta should not be taken with other medicines that affect serotonin, as this can increase the risk of a serious condition called serotonin syndrome. Your health care provider may need to lower your dose of Arynta or use a different medicine if you are taking any of the following.
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
- Tricyclic antidepressants
- Triptans
- Fentanyl
- Lithium
- Tramadol
- Tryptophan
- Buspirone
- St. John's Wort
Some medicines can affect the blood levels of Arynta.
- Medicines called CYP2D6 inhibitors can increase the amount of Arynta in the blood, which can increase your risk of side effects. Your health care provider may need to lower your dose of Arynta. If you are not sure if you are taking a CYP2D6 inhibitor, ask your pharmacist or other health care provider.
- Medicines that change the pH in your urine to make it more acidic such as vitamin C (ascorbic acid) could lower blood levels of Arynta. Your health care provider may need to change your dose of Arynta.
- Medicines that change the pH in your urine to make it more alkaline (basic) such as sodium bicarbonate could increase blood levels of Arynta, which can increase your risk of side effects. Your health care provider may need to change your dose of Arynta or use a different medicine.
This is not a complete list of medicines that may interact with Arynta. Tell your pharmacist or other health care provider about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken. This will help them determine if there are any interactions, or if you need a dosage adjustment.
Is There Any Cost Assistance Available?
There may be options to help you afford Arynta. Azurity Solutions is a program from the drugmaker that can help with medicine approval, access, or copays. Your health care provider can help you get started. For questions or more information, you can contact the drugmaker 800-461-7449 or visit www.azuritysolutions.com.
