Arynta is a medicine used to treat binge eating disorder. Binge eating involves episodes of eating large amounts of food in a short period. You may feel like you cannot control what or how much you eat. Binge eating at least once a week for three months or more is considered binge eating disorder. People with binge eating disorder often have much distress about overeating and they are at an increased risk for obesity. It is different from other eating disorders in that there is not excessive exercise or vomiting. Treatment may include cognitive behavioral therapy, counseling, and medicines.
How Does Arynta Work for Binge Eating Disorder?
The main ingredient in Arynta is lisdexamfetamine, a central nervous system (CNS) stimulant. It is not clear how lisdexamfetamine works for binge eating disorder, but it may work by increasing levels of natural brain chemicals such as norepinephrine and dopamine. If you have binge eating disorder, it can help you overeat less often.
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 will likely start you on a lower dose and may increase your dose every week if needed.
How Was Arynta Studied for Binge Eating Disorder?
There were two studies that looked at the efficacy of lisdexamfetamine, the active ingredient in Arynta, for moderate to severe binge eating disorder.
In the first study, researchers compared two doses (50 milligrams and 70 milligrams) of lisdexamfetamine to a placebo that contained no medicine in 724 adults ages 18 to 55. The people in the study did not know if they were getting lisdexamfetamine or placebo. The study lasted 12 weeks. Moderate to severe binge eating disorder was defined as three or more binge eating days per week for two consecutive weeks and a Clinical Global Impressions-Severity (CGI-S) score of 4 or greater. The CGI-S is a 7-point scale that measures how serious a disease is. A score of 0 is normal and a score of 7 is extremely ill.
The average age of people in the study was 38 years old, and 86% were female. Most were White (75%), 18.5% were African American, 2% were Asian, and less than 1% were American Indian, Alaska Native, native Hawaiian, or other Pacific Islander. The average body mass index (BMI) was greater than or equal to 30. A BMI of 18.5 to 24.9 is considered a healthy weight, 25 to 29.9 is overweight, and BMI greater than or equal to 30 is obesity. The average number of binge eating days per week before the start of the study was 4.7.
All people in the lisdexamfetamine group started treatment with 30 milligrams every day in the morning for the first week. The dose was increased to 50 milligrams every day the second week. During weeks three and four, the dose was increased to 70 milligrams if needed. During weeks four through 12, the optimal dose of 50 milligrams or 70 milligrams was maintained. The main goal of the study was to compare the change in binge eating days per week from baseline until weeks 11 and 12. The people recorded binge eating daily in diaries.
Another study looked at longer-term treatment of binge eating disorder with lisdexamfetamine and time to relapse (return of binge eating symptoms) compared to a placebo. In this study, 267 adults ages 18 to 55 with moderate to severe binge eating disorder who got a response with 12 weeks of open-label lisdexamfetamine were continued on lisdexamfetamine or switched to placebo for up to 26 weeks. Open-label means they knew they were receiving lisdexamfetamine. Response was defined as one or less binge days each week for four consecutive weeks and a CGI-S score of 2 or less. The people in the second part of the study did not know if they were getting lisdexamfetamine or placebo. The main goal of the study was the time to relapse, which was defined as two or more binge eating days per week for two consecutive weeks and an increase in the CGI-S score of 2 or more points compared to baseline.
What Benefits Were Seen?
People who took lisdexamfetamine had a greater reduction from baseline in the number of binge eating days per week after 12 weeks compared to placebo. People who took lisdexamfetamine reduced their number of binge eating days per week by almost four days. People who took the placebo reduced their number of binge eating days per week by less than three days.
In the long-term study, the people who stayed on lisdexamfetamine for six months had a lower risk of binge eating relapse (3.7%) compared to placebo (32.1%). The average dose people took in this study was about 65 milligrams, which means that about half of the people took 50 milligrams and half took 70 milligrams.
Your results may differ from what was seen in clinical studies.
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 relying on the medicine (physical dependence). Your health care provider will monitor you while taking Arynta. Do not share Arynta with others. Talk to your health care provider about these risks.
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 through a medicine take-back program that is offered by the DEA 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 additional 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 developing 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 developing 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:
- Buspirone
- Fentanyl
- Lithium
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
- St. John’s wort
- Tricyclic antidepressants
- Triptans
- Tramadol
- Tryptophan
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.
- Medicines that change the pH of 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 of 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 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 medication 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.
