Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, FDA

Shire plc: U.S. FDA Approves Mydayis[TM] (Mixed Salts of a Single-Entity Amphetamine Product) - A New Once-Daily Option for ADHD Symptom Control in Patients 13 Years and Older



LEXINGTON, Massachusetts, June 20, 2017 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the U.S. Food and Drug Administration (FDA) has approved MYDAYIS[TM] (mixed salts of a single-entity amphetamine product), a once-daily treatment comprised of three different types of drug-releasing beads for patients 13 years and older with Attention Deficit Hyperactivity Disorder (ADHD). Mydayis is not for use in children 12 years and younger. Shire expects to make Mydayis commercially available in the United States in the third quarter of 2017.

The U.S. FDA approval of Mydayis is based on results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects, including adolescents (aged 13 to 17 years) and adults with ADHD. In pivotal, placebo-controlled clinical studies, Mydayis significantly improved symptoms of ADHD, as measured by the ADHD-RS-IV and the Permanent Product Measure of Performance (PERMP), in adults and adolescents. Improvement on the PERMP, an objective, validated, skill-adjusted math test that measures attention in ADHD patients, reached statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hours post-dose.

"Mydayis is the latest innovation in Shire's 20-year legacy of helping to support the treatment of ADHD. It's a testament to Shire's commitment to helping support the evolving needs of appropriate patients with ADHD," said Flemming Ornskov, M.D., MPH, CEO of Shire. "With this approval, we hope to help patients who need a once-daily treatment option. Mydayis has shown efficacy lasting up to 16 hours after taking one capsule, beginning at 2 or 4 hours post-dose."

Andrew J. Cutler, M.D., Executive Vice President and Chief Medical Officer at Meridien Research and an investigator in the Mydayis clinical trials said: "Many of my patients living with ADHD are trying to manage symptoms that impact them in different settings - often across home life, school or work, and in social settings. Patients have individual needs and may respond differently to treatments, so it is important for healthcare professionals to have multiple options. It's rewarding to work with Shire to provide a new treatment option that may help appropriate patients with ADHD."

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.  

In pivotal Phase 3 clinical studies where efficacy was the primary endpoint, a morning dose of Mydayis demonstrated superiority to placebo based on the change from baseline in the ADHD-RS-IV total score for adult and adolescent patients, respectively. The most common adverse reactions associated with Mydayis (incidence ?5% and at a rate at least twice placebo) in adults are insomnia, decreased appetite, decreased weight, dry mouth, increased heart rate, and anxiety. For pediatric patients (13 years and older), the most common adverse reactions were insomnia, decreased appetite, decreased weight, irritability, and nausea.

In Phase 2 studies (two studies in adults and one in adolescents), patients treated with Mydayis demonstrated improved attention compared to placebo, as assessed by the total PERMP score, with results reaching statistical significance beginning at 2 or 4 hours post-dose and lasting up to 16 hours post-dose. Across all clinical studies, adverse events were generally mild to moderate in severity and similar to those observed with other amphetamine compounds.

ADHD is a neurodevelopmental disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. An estimated 4.4% of adults have ADHD in the U.S. When applied to the full U.S. adult population aged 18 and over, approximately 10.5 million adults are estimated to have ADHD in the U.S. Approximately 50 to 66% of children with ADHD may continue to have ADHD symptoms as adults. Medication is not appropriate for all individuals diagnosed with ADHD.

"Being diagnosed with ADHD as an adult helped me understand my symptoms," said Gina D'Angelo, an adult patient with ADHD. "Living with my ADHD symptoms is an ongoing process, and how I navigate my daily responsibilities with ADHD changes as I learn more about it. It is encouraging to see new options that may help adults manage their ADHD symptoms."

Mydayis (mixed salts of a single-entity amphetamine product) Important Safety Information  

What is MYDAYIS[TM]?

Mydayis is a prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older. Mydayis is not for use in 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.


Who should not take Mydayis?  

Do not take Mydayis if you or your child is:  


Problems that can occur while taking Mydayis. Tell your doctor:  

What are possible side effects of Mydayis?  

The most common side effects of Mydayis include:

For additional safety information, click here for Prescribing Information, including Medication Guide and Warning about Abuse, and discuss with your doctor.

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

NOTES TO EDITORS  

Stephen Williams, Deputy Company Secretary, is responsible for arranging the release of this announcement.

Inside Information  

This announcement contains inside information.

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.

About the Mydayis Phase 3 Studies  

Efficacy of Mydayis in adults (aged 18-55 years) was evaluated in a pivotal randomized, double-blind, placebo-controlled study of Mydayis 12.5 mg or 37.5 mg in 275 adult patients (Study 1) who met the DSM-5® criteria for ADHD. The primary endpoint was defined as the change from baseline in the ADHD-RS-IV with prompts total score compared to placebo. When administered as a daily morning dose, Mydayis was superior compared to placebo for both the 12.5 mg and 37.5 mg doses, respectively. In addition, patients treated with either 12.5 mg or 37.5 mg of Mydayis also showed significantly greater improvement compared to placebo on the Clinical Global Impression of Improvement (CGI-I) score, a key secondary endpoint.

In a pooled analysis of three Phase 3 clinical trials conducted in 626 adult ADHD patients, the most commonly reported TEAEs (reported in >5% of Mydayis-treated patients) were insomnia, decreased appetite, dry mouth, decreased weight, increased heart rate, and anxiety. Nine percent of Mydayis-treated patients discontinued due to adverse reactions compared to 2% of placebo-treated patients. The most frequent adverse reactions leading to discontinuation (i.e., leading to discontinuation in at least 1% of Mydayis-treated patients and at a rate at least twice that of placebo) were insomnia (2%), increased blood pressure (2%), decreased appetite (1%), and headache (1%).

The efficacy of Mydayis was further assessed in a study that included 157 adolescent (13 to 17 years old) patients (Study 4). This was a randomized, double-blind, placebo-controlled, dose-optimization study of Mydayis in patients who met the DSM-IV-TR® criteria for ADHD. Subjects were titrated from a dose of 12.5 mg/day until an optimal dose was reached (up to a maximum dose of 25 mg/day). The primary efficacy endpoint was defined as the change from baseline in the ADHD-RS-IV total score when compared to placebo. The primary efficacy analysis demonstrated that Mydayis, administered as a daily morning dose, was superior to placebo with respect to the change from baseline on the     ADHD-RS-IV total score. In addition, Mydayis also showed significantly greater improvement on the CGI-I score at Week 4, the key secondary endpoint in this study.

Among adolescent patients in Study 4, the most commonly reported TEAEs (reported in >5% of Mydayis-treated patients) were decreased appetite, nausea, insomnia, irritability, and decreased weight. Five percent of Mydayis-treated patients discontinued due to adverse reactions compared to zero percent of placebo-treated patients. The most frequent adverse reaction leading to discontinuation (i.e., leading to discontinuation in at least 1% of Mydayis-treated patients and at a rate at least twice that of placebo) were dizziness, depression, upper abdominal pain, and viral infection (all 1%). Safety and effectiveness of Mydayis have not been established in pediatric patients ages 12 years and younger.

About the Mydayis Phase 2 Studies  

The efficacy of Mydayis in adults (aged 18-55 years) was also evaluated in two workplace analog studies. These were multi-center, randomized, double-blind, placebo-controlled, crossover studies in adult patients that evaluated 50 mg (Study 2, N=86, 42 of whom were treated with 50 mg) or 25 mg (Study 3, N=79, 76 of whom were treated with 25 mg) of Mydayis who met DSM-IV-TR® criteria for ADHD. Efficacy was assessed by the PERMP total score, calculated as the sum of the number of math problems attempted plus the number of math problems answered correctly. The PERMP was administered at 2, 4, 8, 12, 14, and 16 hours post-dose. Mydayis treatment reached statistical significance compared to placebo at either 2 hours (Study 2) or 4 hours (Study 3) post-dose and lasting up to 16 hours post-dose in both studies.

In Study 2, no patients in the Mydayis 50 mg treatment group experienced a serious TEAE. The most commonly reported TEAEs (reported in >5% of patients) in the Mydayis 50 mg treatment group included fatigue, insomnia, anorexia, decreased appetite, headache, dry mouth, hypertension.  In Study 3, no patients experienced a serious TEAE. Two patients reported treatment-emergent adverse events (TEAEs) that led to study discontinuation. The most commonly reported TEAEs (reported in >5% of patients) in the Mydayis 25 mg treatment group were insomnia, decreased appetite, dry mouth, headache, and anorexia.

The efficacy of Mydayis in adolescents was also evaluated in a classroom analog study (Study 5, 13 to 17 years, N=84 adolescents). The study was a multi-center, randomized, double-blind, placebo-controlled, crossover study of Mydayis 12.5 mg or 25 mg who met DSM-IV-TR® criteria for ADHD. Efficacy was assessed using the PERMP which was administered at 2, 4, 8, 12, 14, and 16 hours post-dose. Mydayis treatment, compared to placebo, resulted in a statistically significant treatment effect compared with placebo, beginning at 2 hours and continued for up to 16 hours post-dose. In Study 5, TEAEs that were more common in the Mydayis treatment arms (i.e., frequency >5% in either Mydayis treatment arm) were upper abdominal pain, dry mouth, nausea, anorexia, decreased appetite, dizziness, headache, insomnia, irritability, and dysmenorrhea. There were no reported serious TEAEs and no TEAEs led to study discontinuation.

DSM-5 and DSM-IV-TR are registered trademarks of the American Psychiatric Association.

About Mydayis  

Mydayis is 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. Mydayis will be available in 12.5, 25, 37.5 and 50 mg capsules. Visit http://www.mydayis.com for more information.

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 http://www.shire.com.

About Shire  

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.

http://www.shire.com

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

Mydayis is a trademark of Shire LLC.  

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:

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.

For further information please contact:

Investor Relations
Ian Karp
ikarp@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 Houzé
chouze0@shire.com
+1-781-266-3567

 

SOURCE Shire plc


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