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FDA Grants Approval to Market FOCALIN XR(TM) for the Treatment of ADHD in Adults, Adolescents and Children

Posted on: Friday, 27 May 2005, 09:00 CDT

SUMMIT, N.J., May 27 /PRNewswire-FirstCall/ -- Celgene Corporation announced that Novartis Pharma AG, its partner in the development and commercialization of FOCALIN XR, was granted U.S. Food and Drug Administration (FDA) approval for FOCALIN XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children. The approval of FOCALIN XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents and children diagnosed with ADHD.

"FOCALIN XR provides a new treatment option for adults, adolescents and children to address the many difficult symptoms of ADHD," said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. "FOCALIN XR provides patients with a treatment that starts working quickly to alleviate symptoms with the advantage of a once-daily dose that lasts throughout the entire school or work day."

In adults and children, 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.

"We are pleased that Novartis has achieved marketing approval to provide a new treatment option for adults, adolescents and children with ADHD, and for Celgene to realize an important financial milestone." said Sol J. Barer, Ph.D., President and Chief Operating Officer of Celgene Corporation.

About the Adult Study

A 5-week, double-blind, placebo-controlled study involving 221 men and women with ADHD aged 18 to 60, demonstrated FOCALIN XR to be safe and effective in treating ADHD symptoms in adults. Patients received FOCALIN XR or placebo once-daily. Results indicated that FOCALIN XR was statistically superior to placebo, based on changes in 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.

Following the completion of the 5-week double-blind clinical trial, 170 patients continued into a 6-month open-label extension phase. Patients who switched from placebo to FOCALIN XR showed significant clinical improvement and patients continuing treatment with FOCALIN XR 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.

About the Pediatric Study

The efficacy and tolerability of FOCALIN XR for the treatment of ADHD in children was demonstrated in a pivotal clinical trial of children and adolescents aged 6 to 17 years diagnosed with ADHD. In this trial, 103 ADHD patients aged 6 to 17 years received a flexible dose of FOCALIN XR or placebo once-daily for seven weeks. Results indicated that FOCALIN XR was statistically superior to placebo, based on the Conners' ADHD/DSM-IV Scales for Teachers (CADS-T). The CADS-T rating scale is a tool used in clinical trials to assess attention and behavior. FOCALIN XR was generally well- tolerated. The most frequently reported adverse events included decreased appetite, headache, dyspepsia, upset stomach, abdominal pain, and anxiety.

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.

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.

About FOCALIN(TM) and FOCALIN XR(TM)

FOCALIN XR is an advance in single-isomer technology and is formulated by isolating the active d-isomer of methylphenidate, providing favorable tolerability and dosing flexibility at only half the dose. FOCALIN has been approved by the FDA for the treatment of ADHD in children and adolescents. FOCALIN XR, an extended release version, is approved by the FDA for the treatment of ADHD in adults, adolescents and children.

Celgene licensed the worldwide rights (excluding Canada) to FOCALIN and FOCALIN XR to Novartis Pharma AG in exchange for milestone payments and royalties on FOCALIN and the entire Ritalin family of drugs including Ritalin, Ritalin LA, Ritalin SR and ultimately FOCALIN XR. Celgene retained the rights to FOCALIN for oncology-related indications including chemotherapy-induced cognitive dysfunction and cancer fatigue and is currently evaluating FOCALIN for this indication.

About Novartis

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

About Celgene

Celgene Corporation, headquartered in Warren, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of novel therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company's website at http://www.celgene.com/.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control, which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.

Celgene Corporation

CONTACT: Robert J. Hugin, Senior VP and CFO, or Brian P. Gill, DirectorPR-IR, both of Celgene Corporation, +1-908-673-9000

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

Source: PRNewswire-FirstCall

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