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April 22, 2021Evekeo ODT ADHD Indication Expanded
April 21, 2021 – The U.S. FDA has approved an expanded indication for Evekeo® ODT (amphetamine sulfate) orally disintegrating tablets, manufactured by Arbor Pharmaceuticals. The drug is now indicated to treat attention deficit hyperactivity disorder (ADHD) in children who are 3-17 years old. Previously, it was approved only for use in children 6-17 years old.
ADHD can cause children to be easily distracted, impulsive, and highly active beyond what is typical for their age. This can lead to difficulties with social activities and learning, especially in daycare and school settings. According to the U.S. Centers for Disease Control and Prevention, it can also increase a child’s risk of injury. Although behavioral therapy is recommended as first-line treatment for children under the age of six, some patients in this age group may need additional support through medication therapy.
The recommended starting dose for children 3-5 years old is 2.5mg per day. The dose can be increased by 2.5mg on a weekly interval if needed depending on response and tolerability. If necessary, an additional dose can be administered after four to six hours. It is rarely necessary to exceed 40mg/day. Evekeo ODT should be administered in the morning with or without food or liquid by placing the whole tablet on the tongue and allowing it to disintegrate in saliva so it can be swallowed.
Evekeo ODT can be switched with Evekeo tablets on a mg/mg basis but cannot be substituted for other amphetamine products on a mg/mg basis because of different amphetamine salt compositions that affect how the drugs move through the body.
A black box warning cautions that central nervous system (CNS) stimulants such as Evekeo ODT have a high potential for abuse and dependence. Prescribers should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence throughout therapy. Evekeo ODT is a Schedule II controlled substance.
The FDA first approved Evekeo ODT in 2019. The drug’s active pharmaceutical ingredient, amphetamine sulfate, has been FDA approved since 1984.