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New Studies Suggest Investigational Once-Daily ADHD Treatment Is Safe and Effective in Both Children and Adults

Posted on: Monday, 25 October 2004, 08:00 CDT

WASHINGTON, Oct. 25 /PRNewswire-FirstCall/ -- An investigational medication may help adults and children manage Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms, according to three separate studies presented at the 51st Annual Meeting of the American Academy of Child and Adolescent Psychiatry (AACAP). Results from one of the pediatric studies show that Focalin(TM) XR (dexmethylphenidate HCl) extended release capsules may help treat ADHD symptoms for 12 hours.

In children and adults, the core symptoms of ADHD are inattention, impulsivity and hyperactivity; however, in adults symptoms of hyperactivity often subside with maturity or may manifest differently. ADHD is one of the most common psychiatric disorders of childhood and is estimated to affect five to seven percent of children. Many children with ADHD will continue to experience symptoms into adulthood. ADHD is estimated to affect approximately four percent of the adult population.

"Untreated, ADHD can have serious consequences for both children and adult patients. These include impaired performance at work and school, and poor relationships with peers and family members. Identification and treatment of the disorder at any age can help improve these situations," said Lenard Adler, M.D. Associate Professor of Clinical Psychiatry and Neurology at NYU School of Medicine. "These studies show that Focalin XR may be an effective option for both children and adults with ADHD. Furthermore, results of one of the pediatric studies suggest that Focalin XR may be safe and effective in helping to manage symptoms for as long as 12 hours."

Adult Study

The adult study was designed to evaluate the long-term efficacy, safety and tolerability of Focalin XR 20 mg to 40 mg daily. The study was a 5-week, multicenter, double-blind, randomized, placebo-controlled study followed by a 6-month open-label extension. Participants included 221 men and women aged 18 to 60 years who completed the 5-week double-blind clinical trial and 170 patients who continued into the 6-month open-label extension phase. All subjects had a diagnosis of ADHD and the average age was 38.7 years. In the double-blind study, the primary efficacy analysis compared the two higher doses of Focalin XR (30 mg and 40 mg) versus placebo. The secondary efficacy analysis compared the effects of Focalin XR 20 mg versus placebo. Efficacy was measured using the Diagnostic and Statistical Manual-IV (DSM-IV) ADHD Rating Scale, a standard assessment tool used in ADHD. Secondary measures included evaluations rated by patients, clinicians and observers.

At the end of the double-blind study, Focalin XR was statistically superior to placebo on both primary comparisons. The mean change from baseline on the rating scale total score was significantly greater with all doses of Focalin XR than with placebo. Score changes were 7.6 for placebo, 13.3 for patients taking the 20 mg dose of Focalin XR (P=.006), 12.9 for patients treated with the 30 mg dose (P=.012) and 16.5 (P<.001) for patients taking the 40 mg dose (all P values vs. placebo).

At the end of the open label extension, treatment response was evaluated in 103 patients. Patients who switched from placebo to Focalin XR (n=20) showed significant clinical improvement and patients continuing treatment with Focalin XR (n=82) continued to show increasing benefits over six months, based on changes in the DSM-IV ADHD Rating Scale.

Focalin XR was generally well tolerated. The most frequently reported adverse events included headache, insomnia and decreased appetite.

Pediatric Studies

Data presented suggest that Focalin XR is safe and effective in the treatment of children and adolescents with ADHD. One hundred three ADHD patients aged 6 to 17 years participated in a double-blind, placebo- controlled, parallel group study to compare the efficacy and safety of Focalin XR to placebo. Efficacy was evaluated by examining the presence of ADHD symptoms in school, home and clinical environments. In the study, the primary outcome was measured by evaluating change from baseline using the Conners' ADHD/DSM-IV Scales for Teachers (CADS-T). Secondary efficacy measures included evaluations rated by teachers, parents and clinicians. At the end of the study, the mean change from baseline on the CADS-T total subscale score was 16.3 for Focalin XR and 5.9 for placebo (P<.001). Outcomes on all secondary efficacy measures were also statistically significant in favor of Focalin XR.

In a second pediatric study also presented at AACAP, investigators evaluated the efficacy of Focalin XR 20 mg/day at various points throughout the day up to 12 hours. The randomized, double-blind, crossover study included 54 children aged 6 to 12 years with a DSM-IV diagnosis of ADHD who were previously stabilized on methylphenidate 20 to 40 mg/day. Investigators assessed improvement in attention and behavior among study participants in a classroom setting at specific intervals for up to 12 hours post-dose. Improvements were measured using the Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) rating scale, a standard assessment tool used in clinical trials to evaluate attention and behavior. Focalin XR was found to be significantly more effective than placebo in treating ADHD symptoms, as measured by the SKAMP rating scale, at each time point measured.

In both pediatric studies, Focalin XR was generally well tolerated. Adverse events were consistent with those observed in other studies with methylphenidate and dexmethylphenidate.

Focalin XR is an extended release form of the approved drug, Focalin (dexmethylphenidate HCl). Focalin is an advance in single-isomer technology and is formulated by isolating the active d-isomer of methylphenidate. Data suggest that the d-isomer is responsible for the effective management of the symptoms of ADHD. Focalin is available in 2.5, 5 and 10 mg tablets for oral administration and may be administered with or without food.

Like most drugs approved for the treatment of ADHD, Focalin is contraindicated in patients known to be hypersensitive to the drug or to methylphenidate, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette's syndrome. It is also contraindicated during treatment with monoamine oxidase inhibitors and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result). In addition, like most drugs approved for the treatment of ADHD, Focalin is a schedule II drug and should be given cautiously to patients with a history of drug dependence or alcoholism.

About ADHD

ADHD is a neurobiologic disorder that interferes with an individual's ability to regulate activity level and behavior, and sustain focus in developmentally appropriate ways. In adults, it is associated with poor functioning in educational and occupational environments, as well as emotional, social and economic problems.

About Novartis ADHD Treatments

The Novartis ADHD product portfolio includes Ritalin(R) (methylphenidate HCl) tablets, Ritalin-SR(R) (methylphenidate HCl) sustained release tablets, Ritalin LA(R) (methylphenidate HCl) extended release capsules and Focalin tablets. These products are classified as schedule II drugs.

Celgene Corporation of Warren, New Jersey granted Novartis Pharma AG an exclusive worldwide (excluding Canada) license covering its intellectual property rights associated with Ritalin LA, Focalin and Focalin XR. Pursuant to an agreement between Novartis Pharma AG and Novartis Pharmaceuticals Corporation, Novartis Pharmaceuticals Corporation markets Focalin in the U.S.

Ritalin LA and Focalin XR were developed with spheroidal oral drug absorption system (SODAS), a multiparticulate drug delivery system of Elan Corporation, plc . Ritalin LA is being supplied to Novartis under an exclusive worldwide royalty and manufacturing agreement between the companies. Novartis Pharmaceuticals Corporation has commercialization rights to Ritalin LA in the U.S.

The foregoing press release contains forward-looking statements that can be identified by forward-looking terminology such as, "suggest,""may help,""may be safe," or similar expressions, or by express or implied statements regarding potential future approvals of, or potential future revenues from Focalin XR. Such statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. There can be no guarantee that Focalin XR will be approved for marketing in any jurisdiction, or that Focalin XR will reach any particular sales levels. In particular, management's expectation regarding the commercial success of Focalin XR could be affected by among other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis

Novartis has been a leader in the neuroscience area for more than 50 years, having pioneered early breakthrough treatments for Alzheimer's disease, Parkinson's disease, attention deficit/hyperactivity disorder, Epilepsy, Schizophrenia and migraine, many of which continue to be regarded as "gold standards" to this day. Novartis Neuroscience continues to be at the forefront of research and development of new compounds, is committed to addressing unmet medical needs and to supporting patients and families affected by these disorders.

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG , a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 80,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com/.

Contacts

Denise Brashear

Novartis Pharmaceuticals Corporation

+1 862 778 7336 (direct)

+1 917 453 2665 (mobile)

denise.brashear@pharma.novartis.com

Gina Moran

Novartis Pharmaceuticals Corporation

+1 862 778 5567 (direct)

+1 973 476 3643 (mobile)

regina.moran@pharma.novartis.com

Julie Bane

Feinstein Kean Healthcare

+1 617 761 6762 (direct)

+1 617 821 1089(mobile)

jbane@fkhealth.com

Novartis Pharmaceuticals Corporation

CONTACT: Denise Brashear, +1-862-778-7336 (direct), +1-917-453-2665(mobile), denise.brashear@pharma.novartis.com or Gina Moran, +1-862-778-5567(direct), +1-973-476-3643 (mobile), regina.moran@pharma.novartis.com, both ofNovartis Pharmaceuticals Corporation; or Julie Bane of Feinstein KeanHealthcare, +1-617-761-6762 (direct), +1-617-821-1089(mobile),jbane@fkhealth.com

Web site: http://www.novartis.com/

Source: PRNewswire-FirstCall

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