Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that its Attention Deficit Hyperactivity Disorder (ADHD) patch DAYTRANA™ (methylphenidate transdermal system) is effective in patients converted to the patch from efficacious doses of their previous oral long-acting methylphenidate. These phase IIIb clinical trial results were reported today at a major scientific and educational meeting of child and adolescent psychiatrists in San Diego, Calif.
"By the very nature that DAYTRANA is a patch, it provides many benefits to ADHD patients, including the ability to manage the potential for side effects by wearing the patch for a shorter time period than the recommended nine-hour wear time," said lead investigator Thomas Rugino, M.D., Children's Specialized Hospital. "As clinicians, we believe that DAYTRANA can safely and effectively treat patients converted from oral long-acting methylphenidate."
Two additional analyses presented at the meeting also demonstrated positive results with DAYTRANA. One analysis documented that treatment with DAYTRANA did not worsen ADHD-related sleep onset, sleep anxiety, daytime sleepiness, or parasomnias while another analysis evaluated validated parent satisfaction measures, considering both the efficacy and tolerability of DAYTRANA.
DAYTRANA, the first and only ADHD patch, is available in four dosage strengths - 10 mg, 15 mg, 20 mg and 30 mg - all designed for once-daily use. DAYTRANA provides significant symptom control from the first time point measured (2 hours) through 12 hours, with the recommended nine-hour wear time. Noven Pharmaceuticals, Inc. developed DAYTRANA, which combines the active ingredient, methylphenidate, with Noven's patented DOT Matrix™? transdermal technology. This transdermal delivery system was designed to provide continuous medication release throughout the day. The patch is designed to stay on during the normal daily activities of a child such as swimming, exercising, or bathing.
DAYTRANA is Efficacious in Controlling ADHD Symptoms in Patients Converted From Oral Long-Acting Methylphenidate
The purpose of this study was to evaluate the conversion from efficacious doses of oral long-acting methylphenidate to DAYTRANA using efficacy, safety, and tolerability assessments. Converting to DAYTRANA from oral long-acting methylphenidate capsules or tablets resulted in similar efficacy in controlling ADHD symptoms, at the end of week one. The findings were based on a prospective, open-label study of DAYTRANA in children aged 6 to 12 years diagnosed with ADHD.
The ADHD Rating Scale-IV (ADHD-RS-IV) is a standardized, validated test for assessing symptoms of ADHD in children and can be used to assess their response to treatment. When the study began, the average ADHD-RS-IV score of the 164 participants was 14.1 ± 7.48, and at the end of week one, the score did not significantly differ, indicating success of the transition by participants from one of three different oral long-acting methylphenidate formulations to DAYTRANA. The results reported in this poster were based on analyses of the intent-to-treat population.
The trial enrolled children who were already adequately controlled on a stable dose of one of three oral long-acting methylphenidate formulations. They remained on their existing dose of oral long-acting methylphenidate at baseline and then were converted to DAYTRANA using a pre-defined transition schedule. DAYTRANA patches were applied each morning with a recommended nine-hour wear time each day. Participants then entered a three-week dose adjustment period and were maintained on their optimal dose through the final study site visit and evaluation at week four. Investigators followed participants for 30 days after the last dose to assess adverse events.
Other measures of efficacy included the Clinical Global Impressions-Severity and Improvement rating scales, the Parent Global Assessment Scale and the Conners' Parent Rating Scale-Revised. Investigators also evaluated parent and physician satisfaction using the ADHD Impact Module-Child (AIM-C) and Medication Satisfaction Survey.
In the study, DAYTRANA was generally well tolerated, and the most commonly reported adverse events were headache, decreased appetite, insomnia and upper abdominal pain.
In a Separate Study, Treatment with DAYTRANA Showed No Increase in ADHD-Related Sleep Problems
Clinicians and parents frequently report that sleep problems, including delayed sleep onset, night wakings, and shortened sleep duration, are more common and more severe in children with ADHD. According to the analysis also released today, treatment with DAYTRANA in children with ADHD did not worsen sleep onset, sleep anxiety, daytime sleepiness or parasomnias.
In this study, lead investigator Judith Owens, M.D. and her co-investigators assessed the effects of DAYTRANA compared to placebo with reference to a single morning dose of oral long-acting methylphenidate during a seven-week treatment period involving nine visits. The 270 participants stopped their previous ADHD medication at the start of the trial and then were randomized to one of the three treatment groups, but no one knew to which treatment a participant was assigned until the study ended. Parents completed the Children's Sleep Habits Questionnaire (CSHQ), a validated pediatric sleep-measuring tool, at the beginning and throughout the study.
The average CSHQ total number of sleep problems reported declined from the study start to the study end in each group: 5.2 to 3.2 for DAYTRANA, 4.2 to 2.2 for oral treatment and 4.1 to 2.8 for the placebo. The most commonly reported adverse events were decreased appetite, insomnia, nausea and vomiting. No serious adverse events were reported in this study.
Additional Analysis Finds Improved Parent Satisfaction Measures (Using AIM-C and MSS) Evaluating DAYTRANA Effectiveness and Tolerability
The objectives of this double-blind study were to assess the efficacy of 4- and 6-hour wear times of DAYTRANA compared with placebo and evaluate subject and parent/guardian satisfaction with the efficacy and tolerability of DAYTRANA using the ADHD Impact Module-Children (AIM-C) and the Parent Medication Satisfaction Survey (MSS), both validated instruments. Most parents reported improved child and family impact, less difficulty in handling child behavior and fewer missed days from work for parents and school for their child. These results were observed by using the AIM-C rating scale in a laboratory classroom study of DAYTRANA involving 128 children aged 6 to 12 years diagnosed with ADHD. The results reported in this poster were based on analyses of the enrolled participants.
Average child and family impact scores improved from the beginning of the study to its end across all four DAYTRANA doses. When asked at the baseline of the study if it was difficult to handle their child's behavior when the previous medication wears off, approximately 39 percent of parents reported that it was very difficult. However, at the end of the study period with DAYTRANA, approximately 6 percent of parents reported that handling changes in behavior was very difficult. These percentages were based on the number of responders.
Also, a greater percentage of parents reported that their child had not missed any days from school during the past two months (approximately 94 percent while taking DAYTRANA vs. approximately 84 percent prior to taking DAYTRANA). In addition, a greater percentage of parents reported no missed days from work during the past two months due to problems with their child's ADHD at endpoint compared with baseline (approximately 97 vs. 91 percent, respectively).
When asked to rate their overall satisfaction, satisfaction with ease of use and satisfaction with duration of effect of DAYTRANA, approximately 94, 92 and 95 percent of parents indicated that they were satisfied with DAYTRANA as a treatment for their child's ADHD. Percentages were based on the number of responders who "agreed" or "strongly agreed" with MSS satisfaction statements. The most commonly reported adverse events were decreased appetite, headache, insomnia and upper abdominal pain.
The three studies were supported by funding from Shire.
About DAYTRANA
DAYTRANA is a Schedule II controlled substance.
Tell your doctor about any heart conditions, including structural abnormalities, your child or a family member may have. Inform your doctor immediately if the child develops symptoms that suggest heart problems, such as chest pain or fainting.
DAYTRANA should not be used if the child has: significant anxiety, tension, or agitation; allergies to methylphenidate or other ingredients of DAYTRANA; glaucoma; discontinued in the last 14 days or is taking a monoamine oxidase inhibitor (MAOI); tics, or family history or diagnosis of Tourette's syndrome.
Tell your doctor before using DAYTRANA if the child: is being treated for or has symptoms of depression (e.g. sadness, worthlessness, or hopelessness) or bipolar disorder; has family history of tics; has abnormal thoughts or visions, hears abnormal sounds, or has been diagnosed with psychosis; has had seizures or abnormal EEGs; has or has had high blood pressure; exhibits aggressive behavior or hostility. Tell your doctor immediately if the child develops any of these conditions/symptoms while using DAYTRANA.
DAYTRANA was generally well tolerated in clinical studies. The most common side effects reported with DAYTRANA were decreased appetite, sleeplessness, sadness/crying, twitching, weight loss, nausea, vomiting, tics, and affect lability (mood swings). Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugs of this type. Tell your doctor if the child has blurred vision while using DAYTRANA.
Abuse of DAYTRANA can lead to dependence.
Patients converting from another formulation of methylphenidate should start on the 10 mg DAYTRANA patch. DAYTRANA should be applied daily to clean, dry skin, which is free of any cuts or irritation. Skin irritation or allergic skin rash may occur.
For Full Prescribing Information on DAYTRANA, please visit HYPERLINK "DAYTRANA " DAYTRANA or call Shire Medical Affairs at 1-800-828-2088, option 4.
About ADHD
Approximately 7.8 percent of all school-age children, or about 4.4 million U.S. children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most common psychiatric disorders in children and adolescents. ADHD is a neurobiological psychiatric disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. To be properly diagnosed with ADHD, a child needs to demonstrate at least six of nine symptoms of inattention; at least six of nine symptoms of hyperactivity/impulsivity; the onset of such symptoms before age 7 years; that some impairment from the symptoms is present in two or more settings (e.g., at school and home); that the symptoms continue for at least six months; and that there is clinically significant impairment in social, academic or occupational functioning.
Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. The most common standard treatments include educational approaches, psychological or behavioral modification, and medication.
SHIRE PLC
Shire's strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.
Shire's focused strategy is to develop and market products for specialty physicians. Shire's in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.
For further information on Shire, please visit the Company's website: shire.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (guanfacine extended release) (ADHD), SPD465 (extended release of mixed amphetamine salts) (ADHD), MESAVANCE (mesalamine) with MMX technology (SPD 476) (ulcerative colitis), ELAPRASE (idursulfase) (Hunter Syndrome) and NRP104 (lisdexamfetamine dimesylate) (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.
Daytrana™ is a trademark of Shire Pharmaceuticals Ireland Limited.
DOT Matrix™? is a trademark of Noven Pharmaceuticals, Inc.
View drug information on Elaprase.
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