FDA Approves Strattera(R) for Maintenance of ADHD in Children

Tag : atomoxetine hcl

INDIANAPOLIS, IN -- (MARKET WIRE) -- 05/08/08 -- Eli Lilly andCompany ( LLY ) announced today that the United States Food and DrugAdministration (FDA) has approved Strattera® (atomoxetine HCI) formaintenance treatment of Attention-Deficit/Hyperactivity Disorder(ADHD) in children and adolescents. Strattera, a selectivenorepinephrine reuptake inhibitor, is the first FDA-approvednon-stimulant to treat ADHD in children, adolescents and adults.
"The approval provides physicians and their patients with the firsttreatment option that is indicated for maintenance of ADHD," saidThomas J. Spencer, M.D., Associate Professor of Psychiatry, HarvardMedical School. "This is critical as ADHD may be a life-longdisease and effective long-term control of symptoms may meanimproved outcomes in children and adolescents."
The safety and efficacy of Strattera in the maintenance of ADHD wasdemonstrated in one of the largest relapse prevention studies everconducted in ADHD, which is one of the most common mental healthdisorders in children and adolescents.(1)
The 18-month trial of about 600 children and adolescents aged sixto 15 years, who met DSM-IV (Diagnostic and Statistical Manual ofMental Disorders) criteria for ADHD, showed Strattera was superiorto placebo in maintaining continuous efficacy in patients, asmeasured by the ADHD Rating Scale (ADHD-RS). Additionally, at theend of the trial, patients taking Strattera had lower relapse rates(2.5 percent) as compared to patients taking placebo (12.2percent).
Strattera provides uninterrupted relief from ADHD symptomsthroughout the day into the evening. This is important since thesymptoms of ADHD go beyond the work and school day. ADHD patientscan experience frustration, low self-esteem, difficulty withrelationships and increased lifestyle risks.
"In the past, our understanding of ADHD treatment was limited toclinical data on short-term use, meaning a few weeks or a couple ofmonths," said A.J. Allen, M.D., Ph.D., Strattera global medicaldirector for Eli Lilly and Company. "For the first time, clinicianshave guidance that Strattera is effective for up to a year inpatients who respond well to initial treatment."
The long-term, international, multi-center study, which wasreviewed by the FDA as part of its decision to grant this approval,employed a treatment discontinuation design (3 months of acuteopen-label treatment followed by up to 15 months of placebocontrolled maintenance treatment) that enabled investigators totest the efficacy of Strattera as maintenance therapy. In thestudy, 604 patients initially received acute open label treatmentwith Strattera. After 10-weeks, 69% of patients qualified asresponders and were re-randomized to double-blind treatment witheither Strattera or placebo for nine months. A second six-monthrandomization occurred after approximately one year of treatmentwith 81 patients taking Strattera and 82 patients in the placebogroup.
Results of both randomization phases showed that patients treatedwith Strattera had significantly greater continuous response ratesversus patients taking placebo. For child and adolescent ADHDpatients with a good initial response to Strattera and whocontinued to respond well for 1 year, 97.5% maintained response onStrattera vs. 87.8% on placebo (relapse rates 2.5% for Stratteravs. 12.2% for placebo). Additionally, relapse rates for thosediscontinuing treatment after one year were lower than the relapserates for patients who discontinued treatment during the 6 monthsfollowing the open label treatment phase (Strattera, 61/292[20.9%]; placebo, 46/124 [37.1%]).
Strattera was generally well-tolerated. The most common sideeffects reported in the study were headache and the common cold(nasopharyngitis). In the study, the mean final dose of Stratterawas approximately 1.54 mg/kg/day after 12 months and 18 monthstreatment. There were no significant differences in standardizedheight change between groups during the post-randomization period.
About ADHD
ADHD is the most common psychiatric disorder to appear inchildhood. If left untreated, ADHD can have long-term effects on achild's emotional well-being and social skills, like making friendsor doing well at school or at work.(2) ADHD can also have lifelongconsequences, including poor peer relations, poor academic and workperformance and increased risk-taking behaviors, such as substanceabuse.(3)
About Strattera
It is not known precisely how Strattera reduces ADHD symptoms, butscientists believe it works by blocking or slowing reabsorption ofnorepinephrine, a chemical in the brain considered important inregulating attention, impulsivity and activity levels. This keepsmore norepinephrine at work in the spaces between neurons in thebrain. Improved efficiency in the norepinephrine system isassociated with improvement in symptoms of ADHD.(4) Since its firstapproval in the United States in 2002, more than 5 million patientshave taken Strattera worldwide. It has been studied in more than6,000 patients in clinical trials, some for as long as three years.
Important Safety Information for Strattera® (atomoxetine HCl)
In some children and teens, Strattera increases the risk ofsuicidal thoughts. A combined analysis of 12 studies of Stratterashowed that in children and teens this risk was 0.4% for thosetaking Strattera compared to none for those taking a sugar pill. Asimilar analysis in adults treated with Strattera did not reveal anincreased risk of suicidal thoughts. Call your doctor right away ifyour child has thoughts of suicide or sudden changes in mood orbehavior, especially at the beginning of treatment or after achange in dose.
Strattera should not be taken if you or your child: are taking orhave taken within the past two weeks a medicine for depressioncalled a monoamine oxidase inhibitor (MAOI); have an eye problemcalled glaucoma; are allergic to anything in STRATTERA.
Tell your doctor if you or a family member has a history of high orlow blood pressure, increased heart rate, heart or blood vesseldisease or structural heart defects. When on Strattera, tell yourdoctor right away if you have chest pain, shortness of breath, orfainting, as these may be signs of heart-related conditions thatmay be life threatening.
In rare cases, Strattera can cause severe liver problems. Call yourdoctor right away if you or your child has itching, dark urine,yellow skin/eyes, upper right-side abdominal tenderness, orunexplained "flu-like" symptoms.
Tell the doctor about any family history of or if you or yourchild: has bipolar illness (manic-depressive illness); or hassuicidal thoughts or actions before starting Strattera.
If your child develops new psychological symptoms such as abnormalthoughts/behaviors and/or extreme elevated or irritable moods,while taking Strattera you should report them to your child'sdoctor right away.
For male patients, call your doctor right away if you or your childexperience priapism, a painful or prolonged erection lasting morethan 4 hours.
Other rare but serious side effects include: serious allergicreactions including swelling, hives, or other allergic reactions;problems passing urine; and slowing of growth in children. As withall ADHD medications, growth should be monitored during treatmentalthough height and weight data for Strattera measured up to 3years indicates minimal, if any, long-term effects.
Tell your doctor about all prescription and nonprescriptionmedicines that you or your child takes, including vitamins, andherbal supplements. Do not start any new medicine while takingSTRATTERA without talking to your doctor first.
Tell your doctor if you or your child is pregnant, planning tobecome pregnant, or breastfeeding.
In children, the most common side effects were upset stomach,decreased appetite, nausea or vomiting, tiredness, and drowsiness.In adults, the most common side effects were constipation, drymouth, nausea, decreased appetite, dizziness, problems sleeping,sexual side effects, problems urinating, and menstrual cramps. Mostpeople in clinical studies who experienced side effects were notbothered enough to stop using Strattera. Strattera has not beentested in children under 6 years of age or in geriatric adults.
For Medication Guide, visit www.Strattera.com .
For full Prescribing Information, including Boxed Warninginformation, visit http://www.Strattera.com/ .
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing agrowing portfolio of first-in-class and best-in-classpharmaceutical products by applying the latest research from itsown worldwide laboratories and from collaborations with eminentscientific organizations. Headquartered in Indianapolis, Ind.,Lilly provides answers -- through medicines and information -- forsome of the world's most urgent medical needs. Additionalinformation about Lilly is available at www.lilly.com .
This press release contains forward-looking statements aboutStrattera for the treatment of ADHD and reflects Lilly's currentbeliefs. However, as with any pharmaceutical product, there aresubstantial risks and uncertainties in the process of developmentand commercialization, including the risk of side effects and othersafety concerns. There is no guarantee that the product willcontinue to be commercially successful. For further discussion ofthese and other risks and uncertainties, see Lilly's filings withthe United States Securities and Exchange Commission. Lillyundertakes no duty to update forward-looking statements.
(1) National Resource Center on ADHD.