Study Evaluates Two Medications For ADHD

University of Illinois at Chicago researchers are comparing two drugs commonly used to treat attention deficit hyperactivity disorder to determine if genetic factors predict which children will respond to either or both drugs.

Many different medications are used to treat ADHD, including stimulants and non-stimulants, says Dr. Mark Stein, principal investigator of the National Institute of Mental Health-funded study and director of the Hyperactivity, Attention, and Learning Problems Clinic at UIC.

“Unfortunately, clinicians are unable to predict in advance who will respond or not respond to a particular medication,” Stein said.

The study will be conducted in Chicago and New York. Stein and colleagues will enroll 160 children and adolescents between ages 7 and 17 in Chicago. Dr. Jeffrey Newcorn of Mt. Sinai School of Medicine heads the New York site.

Participants will undergo psychiatric evaluations, IQ and achievement tests, a blood test, an electrocardiogram and a physical exam. They will then receive several doses of atomoxetine (a non-stimulant medication), melthylphenidate (a stimulant medication), and a placebo, during a carefully monitored blinded dosing sequence to determine their optimal response to each medication.

During the 12 to 15-week study, researchers will assess the children’s ADHD symptoms, social functioning, problem-solving skills and sleep patterns to determine the efficacy and tolerability of each medication.

Previous research conducted by Stein and colleagues found that children with a variant form of a dopamine transporter gene — a variant known to be associated with ADHD — responded poorly to stimulant medication and had more side effects at lower doses. The new study will test whether patients with this genetic marker respond better to non-stimulant medication.

“At the end of the study we hope to be able to look at a child’s biological characteristics to statistically predict who is more likely to respond to a certain medication and to determine who is more likely not to respond or to have a particular side effect,” Stein said.

“The study provides an idealized standard of care in that the children will be carefully evaluated during their treatment with two different medications, with frequent monitoring that typically does not occur during the normal course of ADHD treatment,” said Stein.

At the end of the trial, participants will be referred back to their primary care provider or given a referral for ongoing treatment with information learned from the study.

Popular ADHD Drug Safe And Effective For Pre-schoolers?

A new study by researchers from the Johns Hopkins Children’s Center and five other medical centers concludes that carefully measured, low doses of methylphenidate (Ritalin) are safe and effective for attention-deficit and hyperactivity disorder (ADHD) in preschoolers. Investigators warn, however, that 3- to 5-year-olds appear more sensitive to the drug’s side effects, which include irritability, insomnia and weight loss, than are older children with ADHD and require closer monitoring.

Children who took the drug also experienced somewhat slower growth rates. On average, children on the drug grew half an inch per year less than expected and gained 2.9 pounds less than expected. Researchers recommend that pediatricians weigh the risks of slowed growth rates against the benefits of treatment. Children on long-term treatment with methylphenidate should be monitored carefully several times a year to assess growth changes over time.

Methylphenidate is the most widely prescribed drug for the treatment of ADHD in children but is not approved by the Food and Drug Administration (FDA) for use in children younger than 6.

Results of the federally funded research, the first large-scale, long-term study of the safety and value of the drug in younger children, appear in a special section of the November issue of the Journal of the American Academy of Child and Adolescent Psychiatry.

“These results give us the missing links in the decision to prescribe a drug that’s been widely used off-label in preschool-age children,” says Mark Riddle, M.D., director of Child and Adolescent Psychiatry at the Children’s Center and a co-author on the study, which followed 303 children between 3 and 5 over 70 weeks. “We were able to confirm what many already suspected-that even lower doses in preschoolers can safely achieve the desired therapeutic effect and indeed that low doses are often optimal.”

Children in the study were started on a low-dose regimen of medication ranging from 3.75 mg total daily to 22.5 mg total daily. By comparison, the cumulative daily dose for older children ranges from 15 mg per day to 50 mg per day. The optimal dose needed to reduce symptoms ranged widely in preschool-age children, but on average, 14 mg daily was effective in reining in symptoms.

“One of the surprises was that in some cases, doses as low as even 3 to 4 mg a day were helpful to some preschoolers, which goes to show that lower doses need to be given a chance before higher doses are tried,” Riddle explains.

About 11 percent of those enrolled in the study experienced side effects severe enough to drop out. These included weight loss, anxiety, skin picking, mood disturbances and insomnia.

“We want parents to know that trained professionals can make an accurate diagnosis and prescribe helpful and safe treatment in preschoolers with ADHD,” Riddle says. “But do expect your prescribing physician to monitor side effects closely and regularly and to tweak the dose if necessary.”

ADHD is characterized by a wide range of symptoms, including inability to concentrate, being easily distracted, fidgeting and restlessness, among others. Left untreated, ADHD can interfere with academic progress and social and emotional development. More than 4.4 million children in the United States have ADHD, according to estimates by the Centers for Disease Control and Prevention. About 2 percent of preschool-age children are believed to have ADHD.

Do Medications Help Young ADHD Drivers Ignore Real World Distractions?

When a song on the radio or the cell phone on the car seat next to a young driver beckon, she may not resist the temptation to turn up the dial or take a call while maneuvering in traffic. Such distractions could lead to a car crash, especially for young drivers with Attention Deficit/Hyperactivity Disorder (ADHD).

As a group, young ADHD drivers are two to four times more likely to have a car accident than non-ADHD drivers. Daniel Cox, Ph.D., professor of psychiatry and neurosciences at the University of Virginia Health System, has conducted research aimed at improving those odds. His team’s newest study will look at the effects of methylphenidate (MPH), a controlled-release stimulant, on young ADHD drivers facing real-life distractions.

“In controlled laboratory studies, there are no cell phones, no pressures to get home before curfew, no passengers encouraging the driver to ‘get air,’ no pets that slip from the driver’s lap down to the pedals and no hamburger dripping with mustard in the driver’s right hand,” said Cox. “This, however, is real world driving. We want to investigate the benefits of medication in the context of such real world distractions and demands.”

This research team’s past studies have compared long- acting MPH to extended-release amphetamine salts and found that MPH is more effective in helping young ADHD drivers pay attention and have fewer driving mishaps while on the road. A second study Cox’s team completed showed that ADHD young drivers fare better when driving cars with manual transmissions rather than automatic transmissions. In this latest study, funded by Shire Pharmaceuticals, Cox’s team hopes to determine the benefits of MPH during routine, daily driving.

In the study, driver performance will be measured using a device called DriveCam. This video system will be mounted inside the vehicle and will measure and record all audio visual signals. When there is a marked change in driving force, DriveCam will store the 10 seconds before the change and the 20 seconds following the change. The study will last six months. For three months of the study, participants will receive MPH administered through a patch.

“We think that the drivers will perform better on the MPH patch than without the medication, even in light of real world situations,” Cox said. “This information will help young ADHD drivers decide what approach may be best.”

Study Suggests Strattera(R) Improved ADHD Symptoms In Patients With Comorbid Alcohol Abuse

Data from a recent clinical study showed Strattera(R) (atomoxetine HCl) improved symptoms of Attention- Deficit/Hyperactivity Disorder (ADHD) in patients with comorbid alcohol abuse disorder, suggesting ADHD can be treated safely and effectively with Strattera in patients with both disorders. Results from the 12-week study were presented today at a major medical meeting of psychiatrists.

The study was designed to test the hypothesis that Strattera is superior to placebo in the treatment of ADHD symptoms and prevention of relapse of alcohol abuse in adult patients with both ADHD and comorbid alcohol abuse disorder who were recently abstinent.

“ADHD is present in at least one-quarter of adults with alcohol abuse or dependence. Treating ADHD in adults with co-occurring alcohol abuse can be challenging, and up until now, no data have been available to help us know how to treat these patients. Often the first course of action is to treat the alcohol problem first, then later the ADHD,” said study author Timothy E. Wilens, M.D., director of substance abuse services in the Pediatric Psychopharmacology Clinics at Massachusetts General Hospital and associate professor of psychiatry at Harvard Medical School in Boston. “While additional studies are needed, this study is encouraging because it is the first to show that ADHD can be treated safely and effectively with Strattera in patients with ADHD and very recent alcohol abuse.”

Results of the study of 147 adults who met full DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria for ADHD and comorbid alcohol abuse, showed that Strattera was superior to placebo in the reduction of ADHD symptoms as measured by the ADHD Investigator Symptom Rating Scale (AISRS). At study endpoint of 12 weeks the reduction of ADHD symptoms in subjects with comorbid alcohol abuse disorder was significantly improved for the Strattera group (-13.63) relative to the placebo group (-8.31). The study showed no significant difference in time to alcohol abuse relapse between the Strattera and placebo treatment groups. However, an exploratory post hoc analysis undertaken to examine drinking throughout the study suggested a positive trend in reducing cumulative heavy drinking days by 26 percent in the treated group compared to placebo, though more study is needed to determine the validity of this specific finding.

ADHD is a potential risk factor for developing alcohol abuse problems.(1) In addition, alcohol abuse problems may be more common among people with ADHD than among those without ADHD. According to data from the National Comorbidity Survey Replication, nearly three times the number of individuals with ADHD (12 percent) have comorbid alcohol abuse or dependence disorder compared to the general population (4.4 percent).(2)

Strattera was generally well-tolerated in this study. Adverse events were similar to those noted in previous trials and discontinuations due to adverse events were not different between groups. The most common adverse events reported were nausea, dry mouth, decreased appetite, dizziness, fatigue, constipation and urinary hesitation. Discontinuation rates reported in this study from adverse events were 9.7 percent for the Strattera group compared to 2.7 percent for the placebo group.

Methods

In this randomized, placebo-controlled study, 72 patients received Strattera (25-100 mg daily) and 75 patients received placebo for approximately 12 weeks, at which time, their ADHD symptoms were measured using the AISRS. Study subjects were recently abstinent from alcohol at least four days before study randomization and included 125 men and 22 women, mean age approximately 34 years-old.

The study design allowed investigators to evaluate whether Strattera is superior to placebo in the treatment of ADHD symptoms and effective in preventing alcohol abuse relapse in adults with ADHD and comorbid alcohol abuse disorder. Time to relapse was defined as four standard alcoholic drinks for females or five standard alcoholic drinks for males within 24 hours, or at least three standard alcoholic drinks per day for at least one week. A standard alcoholic drink was defined in this study as 12 ounces of regular beer, 5 ounces of wine or 1.5 ounces of 80-proof distilled spirits. Cumulative heavy drinking days were measured post hoc with a stratified Andersen-Gill recurrent-event Cox model.

Does Stimulant Treatment For ADHD Increase Risk Of Drug Abuse?

Parents, doctors, and others have wondered whether common treatments for attention-deficit hyperactivity disorder (ADHD) inadvertently predispose adolescents to future drug abuse. The answer may depend on the age at which treatment is started and how long it lasts, say the authors of a new brain-imaging and behavioral study conducted in animals at the U.S. Department of Energy’s Brookhaven National Laboratory. The results appeared in the online issue of the journal Pharmacology, Biochemistry and Behavior.

“Our study shows that the brain’s reward pathways are definitely influenced by methylphenidate, one of the stimulant drugs commonly used to treat ADHD,” said Brookhaven researcher Panayotis (Peter) Thanos, lead author of the study. “But the brain chemistry changes we observed suggest that the developmental stage at which treatment begins and the duration of treatment are important variables that need further study.”

In the study, rats were given methylphenidate mixed with distilled water beginning one month after birth — early adolescence for rats. Animals received either 1 or 2 milligrams methylphenidate per kilogram of body weight, consistent with clinical doses given to children with ADHD. A control group of rats was handled under identical conditions but given plain water.

After two months of treatment, and again after eight months, the scientists performed positron emission tomography (PET) scans to measure the levels of dopamine D2 receptors, a type of brain receptor important for experiencing reward and pleasure that has been linked to pleasure and drug abuse. After the eight-month treatment, animals were also tested for their propensity to self-administer cocaine.

Rats given the 2mg/kg dose of methylphenidate were significantly less likely to press a lever to self-administer cocaine, and received fewer self-initiated infusions of the drug following eight months of treatment than the lower-dose group or the control rats.

The changes observed in brain chemistry were specific to the age and duration of methylphenidate treatment: Specifically, after two months of treatment, brain scans revealed that both groups of treated rats had lower levels of dopamine D2 receptors in their brains than did control animals.

In contrast, after eight months of treatment, the brain scans revealed elevated levels of dopamine D2 receptors in treated rats compared with controls, with the higher-dose treatment group showing the highest level of D2 receptors. In the control group, D2 receptor levels declined with age.

Research at Brookhaven and elsewhere has suggested that low levels of dopamine D2 receptors may increase the likelihood of drug abuse, while elevated levels of dopamine D2 receptors may attenuate the propensity to abuse drugs.

“This new study provides evidence that chronic methylphenidate treatment begun in adolescence affects the brain’s dopamine D2 receptor levels, and thus the brain’s reward circuitry, differently depending on the age and treatment duration,” Thanos said. The scientists’ observation of lower rates of cocaine self-administration in the animals treated for eight months with a 2kg/mg dose of methylphenidate supports this idea.

However, the observation of lower levels of D2 receptors after two months of treatment suggests that shorter lengths of treatment or the age at which treatment is evaluated could result in different effects. “Lower dopamine D2 receptor levels following short-term treatment could make the animals more vulnerable to drug self-administration during early adulthood,” Thanos said. “Unfortunately, we cannot compare cocaine self-administration following eight months of treatment with that obtained after two months of treatment in the same animals, since animals were not tested for cocaine self-administration at this earlier time,” Thanos said. “We wanted to avoid any confounding effect that might have resulted from cocaine exposure during this early developmental stage,” he explained.

Evaluating the effect of treatment duration is one avenue the researchers are exploring in follow-up studies “to help assess optimal duration of treatment regimes to minimize adverse effects on the propensity to abuse drugs,” Thanos said.

Thanos notes that the findings from this study cannot be directly extrapolated to treatment regimes used for ADHD. Also, these studies were done in healthy animals, not in rodent models of ADHD. All experiments were conducted in conformity with the National Academy of Sciences Guide for Care and Use of Laboratory Animals and Brookhaven National Laboratory Institutional Animal Care and Use Committee protocols.

Improved ADHD Identification Leads To Growth In ADHD Medication Use

Attention deficit hyperactivity disorder (ADHD) has been traditionally viewed as a childhood disorder, while ADHD in adults has been underdiagnosed and undertreated. A recent study shows that treatment rates have been increasing in all age groups, and improved identification has contributed to rapidly growing treatment rates for adults. Female patients show the greatest increase of all.

The study, published by SAGE in the May issue of the Journal of Attention Disorders, revealed rapid growth of ADHD medication use in all demographic groups except seniors, with some groups showing markedly faster rates than others. Between 2000 and 2005, treatment rates grew more rapidly for adults than for children, more rapidly for women than for men, and more rapidly for girls than for boys.

Improved diagnosis of ADHD in adult and female patients contributed to the rapid growth in ADHD medication use. The study found that there were many changes in the types of medications used, as well. Researchers found that methylphenidate and dextroamphetamine use declined for both children and adults, the use of amphetamine mixtures increased for adults, atomoxetine use (introduced in 2002) grew rapidly across both groups, use of extended-release products increased in children more dramatically than adults, and generic ADHD medication use declined significantly in pediatric patients while remaining relatively stable in adults.

Research in the field of attention continues to grow. This study is indicative of the type of important data published in the Journal of Attention Disorders, written by leaders in the field and helpful for both professionals and those who must live with attention disorders every day.

Stuttering And ADHD

ADHD affects anywhere from 3 to 7% of children in the United States and recent research indicates that as many as 26% of these children also stutter.

A new brochure published by the Stuttering Foundation seeks to answer questions and give helpful tips for parents and professionals dealing with the two complex issues.

The treatment most often used for ADHD continues to be medication; yet, some recent research indicates that some of these medications may actually aggravate stuttering. Non-stimulant medications such as Strattera may be indicated for ADHD children who also struggle with stuttering.

What can parents do? Joseph Donaher, M.A., of Children’s Hospital of Philadelphia offers 5 timely tips for parents and speech language pathologists:

1. Keep instructions simple and clear and have the child repeat them back. Have a consistent organized schedule.

2. Increase activities where the child must concentrate and focus and cut back on activities that promote aggressive or impulsive behavior as do some television programs.

3. Use frequent praise to keep the child motivated and interested.

4. Provide visual cues and concrete examples to help the child better understand and retain information.

5. Use good speaking habits yourself such as keeping eye contact and using a easy relaxed rate.

New ADHD Drug Strattera

A new drug for the treatment of attention deficit hyperactivity disorder (ADHD) will be listed from 1 July 2007 on the Pharmaceutical Benefits Scheme (PBS).

The drug, Strattera® (atomoxetine), will provide treatment for children between the ages of six and 18 years who cannot take stimulants.

ADHD is a behavioural and developmental disorder that affect young children. The main symptoms of ADHD – inattention, hyperactivity and impulsivity – contribute to adverse academic and social behaviour, which can have consequences that persist throughout adolescence and into adulthood.

Treatment for ADHD normally involves stimulant therapy, so the listing of Strattera® on the PBS will especially benefit those who are unable to take stimulants.

About 18,000 people will commence Strattera® in the first full financial year of listing.

The listing of Strattera® will add around $101.2 million to PBS and Repatriation Pharmaceutical Benefits Scheme expenditure between 2007-08 and 2010-11.

High Dopamine Transporter Levels Not Correlated With ADHD

Results from a brain-imaging study conducted at the U.S. Department of Energy’s Brookhaven National Laboratory in collaboration with Mount Sinai School of Medicine in New York indicate that levels of a brain protein proposed as a diagnostic marker for attention-deficit hyperactivity disorder (ADHD) are not positively correlated with the disease. In fact, the study found lower levels of these “dopamine transporter” proteins in certain brain regions of ADHD patients compared with controls. The study, which will be published in an upcoming issue of the journal Neuroimage and is now available online, also found that for any given level of dopamine transporters in the brain, ADHD patients experienced much higher levels of inattention compared with control subjects.

“These results suggest that dopamine transporter levels alone cannot account for the severity of symptoms of inattention in ADHD,” said Nora Volkow, Director of the National Institute on Drug Abuse and the lead author of the study. Added Gene-Jack Wang, who led Brookhaven’s role in the research, “It is clear from these results that clinical measures of dopamine transporters should not be used as a basis for a diagnosis of ADHD.”

ADHD is the most frequently recognized psychiatric disorder in children, with some 3 million children younger than 18 currently receiving treatment in the U.S. Yet the mechanism underlying this disorder and its treatment are still poorly understood. One prominent theory of ADHD is that there is a dysfunction in brain circuits that depend on the neurotransmitter dopamine to modulate attention, motivation, and interest. If, for example, ADHD subjects have elevated levels of dopamine transporters – proteins on dopamine-producing cells that take up excess dopamine – they could end up with depleted dopamine levels and reduced motivation/attention.

Four independent studies have reported that ADHD subjects have higher than normal levels of dopamine transporters in a brain region called the striatum. But the magnitude of the increase has varied widely, ranging from 70 percent to 5 percent elevations in transporter levels. Two other studies found no elevation of transporter levels, though one found a decrease in dopamine transporter levels in a different brain region.

“Because these discrepancies could reflect differences in medication or drug-abuse histories among subjects, we designed the current study to investigate dopamine transporter levels in ADHD subjects and control subjects while excluding these potentially confounding factors,” Wang said.

The researchers measured dopamine transporter levels in 20 adult ADHD subjects who had never received medication, never abused drugs (except nicotine), and had no past or present history of mental or neurological disease or other medical conditions that could affect cerebral function. They also asked subjects to respond to a questionnaire to gauge levels of inattention. The scientists ran the same tests in 25 healthy control subjects with the same exclusion criteria.

To measure dopamine transporter levels, each subject was given an injection of a radiotracer (a radioactively labeled chemical) designed to bind to dopamine transporters while lying in a positron emission tomography (PET) scanner. The PET camera picks up the radioactive signal from the tracer to precisely measure the level of dopamine transporters.

The PET scans revealed that ADHD subjects had significantly fewer dopamine transporters than control subjects in the nucleus accumbens, an area of the ventral striatum that is one of the main reward centers in the brain. In a dorsal striatum region known as the putamen, which plays an important role in habits and is also involved with attention, dopamine transporter levels did not differ between the two groups.

In both groups, levels of dopamine transporters in the putamen were positively associated with scores of inattention on the self-report questionnaire: the higher the level of transporters, the higher the score of inattention. This finding makes it clear that dopamine transporters play an important role in modulating attention in all people. Yet, for a given level of dopamine transporters, scores of inattention were, on average, five times greater for ADHD subjects than for controls in this study.

“These findings suggest that an additional variable in conjunction with dopamine transporters would be required to account for the severity of the symptoms of inattention in ADHD,” Volkow said. “We speculate that this other variable may be lower levels of dopamine release in ADHD subjects.”

If ADHD subjects release less dopamine to start with, they may end up with lower levels of dopamine transporters as a result of down regulation – that is, the body’s attempt to compensate for lower dopamine levels by reducing the number of reuptake proteins. This would explain the positive correlation between transporter levels and inattention: as the number of reuptake proteins rises, the amount of dopamine would decline, leading to a higher level of inattention. This would also explain why control subjects, with higher dopamine release levels, had lower scores of inattention than did subjects with ADHD with similar levels of dopamine transporters.

Jeffrey Newcorn, a child and adolescent psychiatrist and lead collaborator from Mount Sinai, emphasized that ADHD is not a simple, one-type-fits-all disorder. There are very likely variations in dopamine transporter levels among and even within ADHD subgroups.

“The significant differences across studies and investigators clearly highlight the need to look for factors affecting these inconsistencies to improve our ability to diagnose and treat ADHD,” he said. “Although levels of dopamine transporters alone do not determine whether an individual has ADHD, the association of inattention ratings and transporter levels in both ADHD and normal subjects is consistent with the use of treatments such as stimulant medications, which block activity of the transporter, in ADHD.”

Ongoing research in adults with ADHD, currently being conducted at Brookhaven National Laboratory and Mount Sinai, is investigating the potential long-term impact of treatment with stimulants on the dopamine system.

Novel Treatment For ADHD

Shire plc and its collaborative partner New River Pharmaceuticals Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for VYVANSE (lisdexamfetamine dimesylate, formerly known as NRP104), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). On February 20, 2007 Shire and New River announced an agreement whereby Shire will acquire New River for approximately $2.6 billion in an all cash transaction unanimously recommended by the Boards of both companies. The transaction is the subject of another press release issued February 20, 2007.

VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.

“The FDA approval of VYVANSE is exciting news for Shire as well as for patients, their families, and healthcare providers as it’s an important, novel approach for the treatment of ADHD,” said Matthew Emmens, Shire Chief Executive Officer. “The label we received with the approval letter includes information about the extended duration of effect and abuse-related drug liking characteristics of VYVANSE which illustrate benefits that differentiate this compound from other ADHD medicines. The addition of VYVANSE to our ADHD portfolio reaffirms Shire’s commitment to continue to address unmet medical needs and advance the science of ADHD treatment. Beginning with product launch in Q2 2007, Shire will make VYVANSE our top promotional priority within our ADHD portfolio.”

Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”

The FDA has proposed that VYVANSE be classified as a Schedule II controlled substance. This proposal was submitted to and accepted by the U.S. Drug Enforcement Administration (DEA). A final scheduling decision is expected from the DEA following a 30-day period for public comment. Once VYVANSE receives final scheduling designation, the label will be available. Pending final scheduling designation, product launch is anticipated in Q2 2007. VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.

New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d -amphetamine is covalently linked to l -lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d -amphetamine, which is responsible for VYVANSE’s activity.

Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication’s unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.

Additional information about VYVANSE and other Shire treatments for ADHD is available at http://www.ShireADHDTreatments.com.

VYVANSE Significantly Controls ADHD Symptoms

Data from phase II and phase III clinical trials demonstrated statistically significant improvements in ADHD symptoms for patients aged 6 to 12 years treated with VYVANSE compared to patients treated with placebo. These studies demonstrated that all doses of VYVANSE (30 mg, 50 mg and 70 mg) provided significant efficacy at all time points tested, including 6pm.

In the phase II, analog classroom study, patients demonstrated significantly improved behavior when receiving either VYVANSE or ADDERALL XR ® (mixed salts of a single-entity amphetamine product) as measured by the Swanson, Kotkin, Agler, M. Flynn and Pelham (SKAMP) deportment rating scale, a standardized, validated classroom assessment tool used for evaluating the behavioral symptoms of ADHD. Both treatments resulted in significantly improved behavior versus a placebo ( P