Vyvanse® (lisdexamfetamine dimesylate) CII Available in a New Chewable Tablet Formulation
Vyvanse® (lisdexamfetamine dimesylate) CII Available in a New Chewable Tablet Formulation
For US audiences only
New formulation offers practical administration option for patients prescribed Vyvanse who have difficulty swallowing Vyvanse capsules or would prefer a chewable tablet
April 18, 2017 –– Shire plc is pleased to share that Vyvanse® (lisdexamfetamine dimesylate) CII is now available in the United States in a new chewable tablet formulation. Vyvanse is a prescription medicine that is approved for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and above, and for the treatment of moderate to severe Binge Eating Disorder (B.E.D.) in adults. It is not for weight loss. It is not known if Vyvanse is safe and effective for the treatment of obesity. The new formulation was approved by the U.S. Food and Drug Administration (FDA) in January 2017, for both indications.
“Vyvanse chewable tablets will offer an option to patients who may need an alternate form of this medication,” said Mark Rus, Head of the U.S. Neuroscience franchise, Shire. “Our primary responsibility is to our patients and, with the new Vyvanse chewable formulation, we offer physicians an option to help patients who may have difficulty swallowing or would prefer a chewable tablet to help manage their condition.”
The chewable tablet is for oral administration only. Dosing for the chewable tablet is the same as for the capsule formulation and must be taken as prescribed. Patients must follow the full instructions for taking Vyvanse that are outlined in the Medication Guide. This makes Vyvanse the only medication for ADHD and B.E.D. to offer five administration options to help address the needs of patients.
Vyvanse chewable formulation is available in 10, 20, 30, 40, 50, and 60 mg tablets in select pharmacies in the U.S. Patients should work with their prescriber/doctor to determine if treatment with Vyvanse chewable tablets is appropriate for them.
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 are:
- taking or have 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 taking stimulant medicines, and sudden death, stroke and heart attack have happened in adults taking stimulant medicines. 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 are pregnant or plan to become pregnant. It is not known if Vyvanse may harm your unborn baby.
- if you or your child are breastfeeding or plan to breastfeed. Do not breastfeed while taking Vyvanse. Talk to your doctor about the best way to feed your baby if you take Vyvanse.
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:
Attention-Deficit/Hyperactivity Disorder is a neurodevelopmental 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.
An estimated 10.5 million adults and 6.4 million children in the U.S. are currently living with ADHD. In fact, approximately 50 to 66 percent of children with ADHD in childhood may continue to have ADHD symptoms as adults.
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®). 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. Ongoing assessment and treatment may be necessary.
DSM-5® is a registered trademark of the American Psychiatric Association.
Binge eating disorder (B.E.D.), recognized in the DSM-5 as a distinct eating disorder in 2013, is defined as recurring episodes (on average, at least once weekly, for three months) of consuming an unusually large amount of food in a short time, compared with what others would consume under the same or similar circumstances. Adults with B.E.D. feel a sense of lack of control over eating during a binge eating episode and marked distress over their binge eating episodes. They typically experience shame and guilt about their binge eating, among other symptoms, and may conceal their eating problems. 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. Only a doctor or other qualified HCP can diagnose B.E.D. and determine an appropriate treatment plan.
B.E.D. is the most common eating disorder among U.S. adults, and is more common than anorexia nervosa and bulimia nervosa combined. The disorder occurs in both men and women, is seen across racial and ethnic groups in U.S. adults, and can occur in normal weight, overweight, and obese adults.
NOTES TO EDITORS
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
For further information please contact:
|+1 781 266 3567
SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.
Vyvanse® is a registered trademark of Shire LLC.
Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:
- Shire’s products may not be a commercial success;
- increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire’s future revenues, financial condition and results of operations;
- Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contract manufacturers to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time;
- the manufacture of Shire’s products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
- certain of Shire’s therapies involve lengthy and complex processes, which may prevent Shire from timely responding to market forces and effectively managing its production capacity;
- Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
- the actions of certain customers could affect Shire’s ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely affect Shire’s revenues, financial conditions or results of operations;
- Shire’s products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
- adverse outcomes in legal matters, tax audits and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on the combined company’s revenues, financial condition or results of operations;
- inability to successfully compete for highly qualified personnel from other companies and organizations;
- failure to achieve the strategic objectives with respect to Shire’s acquisition of NPS Pharmaceuticals, Inc., Dyax Corp. (“Dyax”) or Baxalta Inc. (“Baxalta”) may adversely affect Shire’s financial condition and results of operations;
- Shire’s growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
- a slowdown of global economic growth, or economic instability of countries in which Shire does business, as well as changes in foreign currency exchange rates and interest rates, that adversely impact the availability and cost of credit and customer purchasing and payment patterns, including the collectability of customer accounts receivable;
- failure of a marketed product to work effectively or if such a product is the cause of adverse side effects could result in damage to the Shire’s reputation, the withdrawal of the product and legal action against Shire;
- investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in significant legal costs and the payment of substantial compensation or fines;
- Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
- Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which may decrease its business flexibility and increase borrowing costs;
- difficulties in integrating Dyax or Baxalta into Shire may lead to the combined company not being able to realize the expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all; and
- other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including those risks outlined in “ITEM 1A: Risk Factors” in Shire’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2016.
All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.