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Shire Debuts MYDAYIS® and New Research at the 30th Annual Psych Congress

Lexington, MA – September 15, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG) will share new Attention Deficit Hyperactivity Disorder (ADHD) research at the upcoming Psych Congress in New Orleans, Louisiana from September 16-19, 2017. Research will include findings about MYDAYIS® (mixed salts of a single-entity amphetamine product), which was recently approved by the U.S. Food and Drug Administration (FDA) as a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with ADHD. Mydayis is not for use in children 12 years and younger.

“Shire continues to advance our 20 years of ADHD scientific commitment and leadership through new data and evidence generation. In addition to our outcomes and working to address the evolving needs of ADHD patients, Shire will present new research at this year’s Psych Congress focusing on the efficacy and safety profile of Mydayis,” said Manisha Madhoo, MD, Vice President of Global Medical Affairs, Neuroscience, Shire. “Our focus at the Psych Congress will be to provide information to healthcare professionals who may have questions about the recently FDA approved treatment, Mydayis, and how it may be a tool they can use in their clinical practices for appropriate patients.”

Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.

Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your healthcare provider can tell you more about the differences between physical and psychological dependence and drug addiction.

Mydayis is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Mydayis in a safe place to protect it from theft. Never give Mydayis to anyone else, because it may cause death or harm them. Selling or giving away Mydayis may harm others and is against the law.

In addition to presenting new research, Shire is sponsoring a panel moderated by Dr. Jennifer Ashton, ABC News’ Chief Women’s Health Correspondent to discuss a new treatment option and the individual needs of adult patients with ADHD. Shire will also have a branded booth where attendees will be able to speak to representatives, learn more about Shire products and the company’s commitment to the ADHD community.

Research on Mydayis will provide important insights on the efficacy and safety profile of the drug amongst adults with ADHD included in the clinical trials. Additionally, Shire will share research focused on the continued evolving needs and symptom burden of patients to more effectively identify and help treat ADHD in adults.

“I look forward to learning more about the research on Mydayis and the evolving needs of adults with ADHD at the Psych Congress,” said Dr. Matthew Brams, Assistant Professor of Clinical Psychiatry at Baylor College of Medicine. “I see many patients who’ve asked for different approaches to help manage their ADHD symptoms. This new information can expand the tools available to clinicians, helping them to work with their patients on treatment plans.”

Specific presentations include:  

Mydayis Research

  • Poster #120; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Efficacy and Safety of SHP465 Mixed Amphetamine Salts Extended-Release in Adults With Attention-Deficit/Hyperactivity Disorder; Presented by B. Robertson
  • Poster #119; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Effects of SHP465 Mixed Amphetamine Salts Extended-Release on Patient Global Functioning and Vital Signs in Adults With Attention-Deficit/Hyperactivity Disorder; Presented by M. Yu
  •  Poster #121; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Effects of Food on the Bioavailability of Amphetamine in Healthy Adults After Administration of SHP465 Mixed Amphetamine Salts; Presented by Y. Wang

ADHD Research

  • Poster #248; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Unmet Medication Coverage Needs Among Adults with Attention Deficit/Hyperactivity Disorder (ADHD) (Patient Burden Survey); Presented by E. Flood
  • Poster #249; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Persisting Psychosocial Impairments in Adults Being Treated with Medication for Attention Deficit/Hyperactivity Disorder (ADHD) (Patient Burden Survey); Presented by E. Flood
  • Poster #127; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Symptom Burden Among Self-Reported ADHD Adults in the United States; Presented by A. Khachatryan
  • Poster #126; Sunday, September 17, 2017 from 1:30PM – 2:30PM: US Normative Data for the Adult ADHD Self-Report Scale (ASRS-V1.1); Presented by A. Khachatryan
  • Poster #150; Sunday, September 17, 2017 from 1:30 – 2:30PM: Healthcare Providers’ Perspectives on Diagnosing and Treating Adults with Attention Deficit/Hyperactivity Disorder (ADHD); Presented by B. Romero
  • Poster #226; Sunday, September 17, 2017 from 1:30PM – 2:30PM: Adherence and Persistence on Long-acting Monotherapy and Combination Therapy among Commercially-insured Adults with Attention-Deficit Hyperactivity Disorder (ADHD) in the US; Presented by S. Kelkar

The poster presentations are intended for scientific discussion only.

MYDAYIS IMPORTANT SAFETY INFORMATION

What is MYDAYIS®?

Mydayis is a prescription medicine for ADHD in patients 13 years and older. Mydayis is not for children 12 years and younger.

IMPORTANT SAFETY INFORMATION

Abuse and dependence. Mydayis, other amphetamine containing medicines, and methylphenidate have a high chance for abuse and can cause physical and psychological dependence. Your healthcare provider should check you or your child for signs of abuse and dependence before and during treatment with Mydayis.

Tell your healthcare provider (HCP) if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs. Your HCP can tell you how physical and psychological dependence and drug addiction are different.

Mydayis is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep Mydayis in a safe place to protect it from theft. Never give Mydayis to anyone else, because it may cause death or harm them. Selling or giving away Mydayis may harm others and is against the law.

Who should not take Mydayis?
Do not take Mydayis if you or your child is:

  • allergic to amphetamine or any of the ingredients in Mydayis. See Medication Guide for a list of ingredients.
  • taking or have taken a medicine for depression (monoamine oxidase inhibitor [MAOI]) within the past 14 days.

Serious problems can occur while taking Mydayis. Tell your HCP:

  • if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. Sudden death has occurred in people with heart problems or defects taking stimulant medicines. Sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Your HCP should check you or your child carefully for heart problems before starting Mydayis. Since increases in blood pressure and heart rate may occur, your HCP should regularly check these during treatment. Call your HCP or go to the ER right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Mydayis.
  • if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. New or worse behavior and thought problems or new or worse bipolar illness may occur. New psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms may occur. Call your HCP right away if you or your child have any new or worsening mental symptoms or problems during treatment, especially hearing voices, seeing or believing things that are not real, or new manic symptoms.
  • if your child is having slowing of growth (height or weight). The HCP should check your child’s height and weight often while on Mydayis, and may stop treatment if a problem is found. Mydayis is not for children 12 years and younger.
  • 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. Call your HCP if you or your child have any of these symptoms or any signs of unexplained wounds appearing on fingers or toes while taking Mydayis.
  • if you or your child have a seizure. Your HCP will stop treatment.
  • if you or your child have symptoms of serotonin syndrome: agitation, hallucinations, coma, or changes in mental status; problems controlling movements or muscle twitching, stiffness, or tightness; fast heartbeat; sweating or fever; nausea, vomiting or diarrhea. Call your HCP or go to the ER if symptoms occur. Serotonin syndrome may occur if Mydayis is taken with certain medicines and may be life-threatening.
  • if you or your child are or become pregnant or plan to become pregnant. It is not known if Mydayis may harm your unborn baby.
  • if you or your child are breastfeeding or plan to breastfeed. You should not breastfeed while taking Mydayis. Mydayis passes into breast milk.

What are possible side effects of Mydayis?
The most common side effects of Mydayis include:

  • trouble sleeping
  • decreased appetite
  • dry mouth
  • increased heart rate
  • anxiety
  • nausea
  • irritability
  • weight loss

For additional safety information, click for Medication Guide and discuss with your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

NOTES TO EDITORS

More About ADHD

Attention Deficit Hyperactivity Disorder (ADHD) impacts people in multiple settings – even beyond work into daily tasks, at home or in social settings.

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 healthcare professional can evaluate and diagnose ADHD.

Although there is no cure for ADHD, there are accepted treatments that have demonstrated improvement in ADHD symptoms. A comprehensive approach is often advised, which may include a combination of medication, psychotherapy and educational approaches. Ongoing assessment of ADHD management plans is recommended.

Shire’s Commitment to ADHD

Shire is a global leader in ADHD education and treatment. We have more than 20 years of experience in providing treatments for ADHD. We regularly share our expertise with physicians, patients, care givers and policymakers in order to raise awareness and broaden understanding of this condition. Learn more at www.shire.com.

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases. 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.

www.shire.com

For further information please contact:

Investor Relations
Ian Karpikarp@shire.com+1 781 482 9018
Robert Coates rcoates@shire.com+44 1256 894874
Media
Gwen Fisher gfisher@shire.com+1 781 482 9649
Clotilde Houzéchouze@shire.com+1 781 266 3567

SHIRE and the Shire Logo are registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affiliates.

MYDAYIS is a registered trademark of Shire LLC.

Mydayis is available in capsule form (12.5, 25, 37.5 and 50 mg).

Forward-Looking Statements

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, among other things, 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 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, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated 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 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 has increased its borrowing costs may decrease its business flexibility; and a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

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.

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