FDA approves Adderall XR (R) to treat ADHD in adults

Main Category: ADHD
Article Date: 14 Aug 2004 - 1:00 PDT


Adderall XR is first stimulant medication approved for Attention Deficit Hyperactivity Disorder in Adults.

Philadelphia, Pa. - Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the US Food and Drug Administration (FDA) has approved ADDERALL XR® (mixed salts of a single-entity amphetamine) as a once-daily treatment for adults with Attention Deficit Hyperactivity Disorder (ADHD). Since 2001, ADDERALL XR has been approved in the U.S. for the treatment of ADHD in children.

Up to 65 percent of children with ADHD may still exhibit symptoms into adulthood and an estimated 4.4 percent of the U.S. adult populations are affected by ADHD. If left untreated, this disorder may lead to other psychological difficulties, such as depression, as well as occupational and social disability. Appropriate diagnosis and treatment of ADHD in adults helps improve self-esteem, work performance and skills, educational attainment and social competencies. Over eight million adults in the U.S. may exhibit the symptoms of ADHD, while only 600,000 are actively taking medication.

"ADHD in adult patients may significantly impair a person's social and family relationships, as well as his or her career," said Richard H. Weisler, M.D., adjunct professor of psychiatry at the University of North Carolina, Chapel Hill (UNC) School of Medicine and principal investigator for ADDERALL XR studies in adults. "Stimulant therapies, like ADDERALL XR, have been used successfully in patients for more than 60 years. It's an important step that ADDERALL XR is the first stimulant to be approved for use in adults."

According to a recent national survey, "Capturing America's Attention," the repercussions of untreated ADHD may have limited adults with the condition from reaching their full academic and occupational potential, and limited their satisfaction with themselves and their relationships. Adults with ADHD are twice as likely to be divorced or separated and have had almost twice as many jobs in the past ten years compared to adults without ADHD. Importantly, 43 percent of those adults with ADHD report that they lost or left one or more of those jobs due in some part to their ADHD symptoms. Adults with ADHD are three times more likely to suffer from stress, depression or other problems with emotion; more likely to engage in harmful or antisocial behaviors; and report lower educational achievement, the survey found.

"We are very pleased to be bringing this effective therapy to adults whose lives are affected by ADHD symptoms." said Greg Flexter, Executive Vice President and General Manager of Sales and Marketing, Shire North America. "There has long been an unmet need for treatment among the adult population despite an increasing awareness of ADHD's potential impact on quality of life. We hope that this approved treatment option will encourage adults with ADHD to seek diagnosis and appropriate treatment. We also hope that treatment will help them pursue fulfilling, engaging lifestyles that are not affected by this condition."

The FDA based its approval on data from a four-week, multi-center, double-blind Phase 3 pivotal trial of 248 adult patients. ADDERALL XR, dosed once-daily, demonstrated significant control of ADHD symptoms at week one, the first evaluation period, and maintained this significant improvement throughout the four-week study. The primary measurement of symptom control was the ADHD Rating Scale (ADHD-RS), a validated scale used by clinicians to assess each of the 18 individual criteria symptoms of ADHD in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, a publication of the American Psychiatric Association.

At the end of the trial, the average ADHD-RS Total Scores for patients taking ADDERALL XR were 49% lower compared with the average scores at the beginning of the trial prior to receiving the medication. Shire recently presented long-term data using ADDERALL XR in adults. The data demonstrated that significant symptom improvement was maintained over 18 months.

The most frequently seen side effects of ADDERALL XR in the adult clinical trial included dry mouth, difficulties sleeping, dizziness, headache, loss of appetite, nausea, rapid heart rate and weight loss.

About ADDERALL XR

ADDERALL XR may not be right for everyone. ADDERALL XR was generally well tolerated in clinical studies. Patients should speak with their doctor if they have a history of high blood pressure or any heart conditions, glaucoma, thyroid problems, emotional instability, mental illness, or a known allergy to this type of medication. If you are currently taking or have recently taken a type of antidepressant called a MAO inhibitor or have a pre-existing structural cardiac abnormality, you should not take ADDERALL XR. There is a potential for worsening of motion or verbal tics and Tourette's syndrome. Abuse of amphetamines may lead to dependence. Misuse of amphetamine may lead to serious cardiovascular adverse events. A patient should report any new psychological symptoms to his or her physician.

About ADHD

ADHD is a neurobiological disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity more frequent and severe than typically observed in individuals at a comparable level of development. Diagnosing ADHD in adults can help put many of their difficulties into perspective and help them better understand the reasons behind many lifelong symptoms. Proper diagnosis and effective treatment can help improve self-esteem, work performance and skills and social competencies.

Shire Pharmaceuticals Group plc

Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company's Web site: http://www.shire.com.

The "Safe Harbor" Statement Under the Private Securities Litigation Reform Act of 1995

Statements included herein that are not historical facts, 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 affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire's Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to the expected product approval dates of lanthanum carbonate (FOSRENOL®), methylphenidate transdermal system (MTS) and XAGRID®, the implementation of the planned reorganization and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission.

Contacts:Elizabeth Pallotta
212-601-8134
Marion E. Glick
212-601-8273
Porter Novelli

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