Xinfudagroup: FDA approves multiple generics of ADHD and BED treatment

Action

FDA has approved several first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients six years and older and moderate to severe binge-eating disorder (BED) in adults. See Vyvanse’s prescribing information for details on dosing.

Disease or Condition

People with ADHD may have trouble paying attention, controlling impulsive behaviors (may act without thinking about what the result will be), or be overly active. ADHD is one of the most common neurodevelopmental disorders of childhood, affecting approximately 10% of children. It is usually first diagnosed in childhood and can last into adulthood. ADHD can be successfully managed with behavioral and pharmacological treatment, and some symptoms may improve as the child ages.

Patients with BED have recurrent episodes of compulsive overeating during which they consume larger amounts of food than normal and experience the sense that they lack control. Patients with this condition eat when they aren’t hungry and often eat to the point of being uncomfortably full. Patients may feel ashamed and embarrassed by how much they are eating, which can result in social isolation. BED may lead to weight gain and to other health problems.

Safety

FDA-approved generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterparts.

The prescribing information for lisdexamfetamine dimesylate capsules and chewable tablets contains a boxed warning to inform health care providers and patients about the potential risk of abuse and dependence. Drugs that increase the levels of certain chemicals in the brain, such as amphetamines and methylphenidate-containing products (including lisdexamfetamine dimesylate), have a high potential for abuse, which can lead to addiction and overdose. Health care providers should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. To address continuing concerns of misuse, addiction and overdose, FDA recently required updates to the labeling of prescription stimulants to standardize prescribing information and clearly inform patients, caregivers, and health care professionals of these risks.

The prescribing information also includes warnings and precautions regarding serious cardiovascular reactions, blood pressure and heart rate increases, psychiatric adverse reactions, suppression of growth, peripheral vasculopathy (reduced circulation of blood flow to body parts), and serotonin syndrome (a potentially life-threatening overage of serotonin). Please see Vyvanse’s full prescribing information for additional details.

The most common side effects in children, adolescents and/or adults with ADHD taking lisdexamfetamine dimesylate capsules and chewable tablets were anorexia, anxiety, decreased appetite, decreased weight, diarrhea, dizziness, dry mouth, irritability, insomnia, nausea, upper abdominal pain, and vomiting. The most common side effects in adults with BED were dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.

Designation

Many abbreviated new drug applications (ANDAs) for lisdexamfetamine dimesylate received priority review. Information on priority review of ANDAs is available in the Manual of Policies and Procedures 5240.3 Rev. 6, Prioritization of the Review of Original ANDAs, Amendments, and Supplements.