BASINGSTOKE, U.K., and PHILADELPHIA, Aug. 26 Shire Limited (LSE: SHP, Nasdaq: SHPGY), the global specialtybiopharmaceutical company, has announced that VYVANSE is now available in U.S.pharmacies nationwide in three additional dosage strengths, bringing the totalnumber to six: 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg. The expandedVYVANSE dosing options will allow physicians to individualize treatment foreach patient. VYVANSE, which received FDA approval for the treatment of ADHDin children in 2007, was also recently approved to treat ADHD in adults.
VYVANSE is the first prodrug stimulant approved to treat ADHD and wasshown to provide consistent delivery of active medication from patient topatient. In clinical studies of VYVANSE in children and adults, VYVANSEshowed significant improvement in the core ADHD symptoms of inattention,hyperactivity, impulsivity. In children, VYVANSE demonstrated significantefficacy throughout the day, even at 6pm, as reported by parents.
VYVANSE Has Nationwide Formulary Coverage
Since the availability of VYVANSE a year ago to treat children with ADHD,VYVANSE has achieved a U.S. market share of more than 8 percent based onweekly branded prescription volume, with an average second quarter 2008 marketshare of 7.4 percent. VYVANSE formulary coverage has been positive; the topsix managed care plans now cover the product in a preferred formularyposition, and as of June 30, 2008, Shire has executed agreements with nine ofthe top 11 managed care organizations. At a national level, more than 92percent of VYVANSE prescriptions are approved without restrictions (whichmeans without requiring any additional steps from the doctor or patient), andVYVANSE has a competitive copay among covered formulary plans.
ADHD May Affect Adults in All Aspects of Daily Life
Although many people tend to think of ADHD as a childhood problem, up to65 percent of children with ADHD may still exhibit symptoms into adulthood.The disorder is estimated to affect 4.4 percent of U.S. adults aged 18-44based on results from the National Comorbidity Survey Replication, anationally representative household survey, which used a lay-administereddiagnostic interview to assess a wide range of DSM-IV disorders. When thispercentage is extrapolated to the full U.S. population, approximately 9.8million adults are believed to have ADHD.
"The prevalence of ADHD is concerning to the medical community. ADHD mayaffect adults in their professional life, social life, and relationships,"said Greg Mattingly, M.D., associate clinical professor at the department ofpsychiatry at Washington University School of Medicine in St. Louis, Mo."VYVANSE is a recently approved ADHD treatment option for the adultpopulation. In a clinical study with adults, VYVANSE was shown, within thefirst week, to significantly improve ADHD symptoms, inattention, such as theability to focus and organize, and hyperactivity and impulsivity, such asrestlessness, and interrupting."
VYVANSE is a therapeutically inactive prodrug, in which d-amphetamine iscovalently bonded to l-lysine, and after oral ingestion it is converted topharmacologically active d-amphetamine. The conversion of VYVANSE tod-amphetamine is not affected by gastrointestinal pH and is unlikely to beaffected by alterations in normal GI transit times.
Additional information about VYVANSE and Full Prescribing Information areavailable at www.vyvanse.com.
Vyvanse is indicated for the treatment of ADHD. Efficacy based on twocontrolled trials in children aged 6 to 12 and one controlled trial in adults.
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