Shire Submits NDA to FDA for New Formulation of Vyvanse® (lisdexamfetamine dimesylate) CII as Chewable Tablets
In the U.S., Vyvanse capsules are indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages six and above and for the treatment of moderate to severe Binge Eating Disorder (B.E.D.) in adults. Vyvanse is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. The proposed indications for Vyvanse chewable tablets are the same as the currently FDA-approved indications for Vyvanse capsules.
“Patients are always our top priority at Shire. We’re looking forward to FDA review of this application because Vyvanse chewable tablets provide an additional option for patients who may prefer taking medication in this manner,” said Perry Sternberg, Head of Neuroscience, Ophthalmics and Commercial Excellence, Shire.
Two clinical pharmacology studies (SHP489-126 and SHP489-127) formed the basis of this application. Study SHP489-126 demonstrated that the chewable tablet formulation is bioequivalent to the capsule formulation after a single oral dose administration of each. Study SHP489-127 established that the chewable tablet formulation is bioequivalent in both a fasting and non-fasting state. Based on these clinical pharmacology studies, the clinical profile of Vyvanse chewable tablets is thought to be comparable to the current formulation.
The Vyvanse chewable tablet has not been approved in any country. The tablet would be administered orally, once daily in the morning. Patients must follow the full instructions outlined in the Medication Guide for taking Vyvanse.
IMPORTANT SAFETY INFORMATION
Vyvanse is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Vyvanse in a safe place to prevent misuse and abuse. Selling or giving away Vyvanse may harm others, and is against the law.
Vyvanse is a stimulant medicine. Tell the doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Who should not take Vyvanse?
Do not take Vyvanse if you or your child is:
- taking or has taken an anti-depression medicine called a monoamine oxidase inhibitor (MAOI) within the past 14 days.
- sensitive or allergic to, or had a reaction to other stimulant medicines.
Problems that can occur while taking Vyvanse. Tell the doctor:
- if you or your child have heart problems or heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in people with heart problems or defects, and sudden death, stroke and heart attack have happened in adults. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Vyvanse.
- if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
- if you or your child have circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature and/or change color from pale, to blue, to red. Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking Vyvanse.
- if your child is having slowing of growth (height and weight); Vyvanse may cause this serious side effect. Your child should have his or her height and weight checked often while taking Vyvanse. The doctor may stop treatment if a problem is found during these check-ups.
- if you or your child is pregnant, breast-feeding, or plan to become pregnant or breast-feed.
What are possible side effects of Vyvanse?
The most common side effects of Vyvanse reported in ADHD studies include:
The most common side effects of Vyvanse reported in studies of adults with moderate to severe B.E.D. include:
For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.
Vyvanse capsules are available in 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg strengths.
Attention-Deficit/Hyperactivity Disorder (ADHD) is a neurobehavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development and is inconsistent with developmental level.
ADHD is one of the most common childhood psychiatric disorders. An estimated 11 percent (6.4 million) of US school-aged children have been diagnosed with ADHD in their lifetime, based on the 2011/12 National Survey of Children’s Health, in which parents were asked if a health care practitioner had ever told them their child had ADD or ADHD. Although many people tend to think of ADHD as a childhood problem, 60% to 85% of children with ADHD may continue to meet the criteria for the disorder during their teenage years. Nearly 50% of children with ADHD may continue to meet the criteria for the disorder in adulthood, based on parent report. The disorder is estimated to affect 4.4 percent of US adults aged 18 to 44 based on results from the National Comorbidity Survey Replication.
When this percentage is extrapolated to the full US population aged 18 and over, approximately 10 million adults are estimated to have ADHD. Drug treatment may not be appropriate for all patients with ADHD.
The specific etiology of ADHD is unknown. The diagnosis is made utilizing criteria specified in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5®) or International Classification of Diseases, 10th revision (ICD-10). Only a trained health care professional can evaluate and diagnose ADHD.
Although there is no cure for ADHD, there are accepted treatments that have been demonstrated to improve symptoms. Standard treatments include educational approaches, psychological therapies which may include behavioral modification, and/or medication.
Binge Eating Disorder (B.E.D.), recognized as a distinct disorder in 2013 by the American Psychiatric Association (APA), is defined as recurring episodes (on average, at least once weekly, for 3 months) of consuming a large amount of food in a short time, compared with what others would consume under the same or similar circumstances. Patients feel a sense of lack of control over eating during a binge eating episode and marked distress over their binge eating. They typically experience shame and guilt, among other symptoms, about their binge eating, and may conceal the symptoms. Unlike people with other eating disorders, adults with B.E.D. don’t routinely try to “undo” their excessive eating with extreme actions like purging or over-exercising. Adults with moderate to severe B.E.D. usually binge four to thirteen times per week. Only a doctor or other trained health care professional (HCP) can diagnose B.E.D. and determine an appropriate treatment plan.
B.E.D. is the most common eating disorder in U.S. adults and is more prevalent than anorexia and bulimia combined. The disorder occurs in both men and women, is seen across racial and ethnic groups, and can occur in normal weight, overweight, and obese adults. Medication is not appropriate for all adults with B.E.D.