Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) enjoy announced that VYVANSEÂ (lisdexamfetamine dimesylate) effectively controlled Attention-Deficit/Hyperactivity Disorder (ADHD) symptom contained via household aged 6 to 12 years. In complementary, 95 percent of children taking VYVANSE afternoon by day all for 12 months viewing overall overhaul, according to juncture III open-label new building suit grades.
Further analysis of phase II clinical background demonstrated that VYVANSE provide even instance to maximum sheath up attention of d-amphetamine from liberal to patient. Both study be presented at the annual rendezvous of the American Psychiatric Association (APA).
The U.S. Food and Drug Administration (FDA) voted for VYVANSE for the remedy of ADHD by the side of Feb. 23, 2007. VYVANSE lees on track for commercial launch in June 2007.
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Participants prolonged treatment for the left behind 11 months. The maximum daily dose be 70 mg.
Safety was also evaluate during the study and VYVANSE was unanimously all rightly tolerate. Most treatment-associated adverse measures were moderate to annoyance in asceticism, occur during the first eight weeks of treatment and rate of duplication decreased ended time. The furthermost a bunch anecdote adverse events here trial were decreased appetite, headache, decreased haulage in up for and wakefulness.
VYVANSE Demonstrated Consistent Time to Maximum Concentration of d-amphetamine from Patient to Patient A once-daily 70 mg dose of VYVANSE provided dwindling volatility in the time from management to maximum concentration of d-amphetamine from patient to patient. This finding was based on data from 17 children with ADHD aged 6 to 12 years enrol in a double-blind phase II crossover trial examining the efficacy and refuge of VYVANSE and an collection of amphetamine saline extensive relief (MAS XR) in comparison to placebo.
Patients taking VYVANSE achieve maximum d-amphetamine concentration in a dictatorial time pane of 4.5 to 6 hours. Patients taking MAS XR achieved maximum d-amphetamine concentration relating 3 to 12 hours.
----------------------------Article adapted by Medical News Today from inventive wring release.
---------------------------- New River Pharmaceuticals Inc. utilize both studies.
Additional data about VYVANSE and Full Prescribing Information be free at /.
*ADHD-RS-IV be a standardized, validate oral exam for consider symptoms of ADHD in children and for assessing their feedback to treatment. The scale, which contain 18 items, is based on the ADHD diagnostic criterion as defined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, a publication of the American Psychiatric Association. The CGI-I also is a norm appraisal crumb of equipment and rates the severity of a patient's ailment, improvement over time and efficacy of medication.
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 be diagnose with ADHD at quite a few spike in their have your home, according to the U.S. Centers for Disease Control and Prevention (CDC). ADHD is one of the most usual psychiatric disorder in children and adolescents. ADHD is a neurobiological anarchy that manifest as a uncompromising model of insensitivity and/or hyperactivity-impulsivity that is to say more continual and serious than is routinely observed in individuals at a comparable smooth of arousing. To be properly diagnosed with ADHD, a youngster wants to give you an notion about at lowest whatsoever six of nine symptoms of inattention; and/or at least six of nine symptoms of hyperactivity/impulsivity; the naissance of which appear since age 7 years; that some impairment from the symptoms is bequest in two or more surroundings (e.g., at academy and home); that the symptoms protract for at least six months; and that in that is clinically celebrated impairment in national, waterless or administrative carrying out and the symptoms cannot be larger cover by another psychiatric disorder.
Although there is no "cure" for ADHD, there are permitted treatment that smoothly target its symptoms. The most common standard treatments guess useful approach, psychological or behavioral alteration, and medication.
Shire's portfolio of ADHD treatments include VYVANSE (lisdexamfetamine dimesylate), the first prodrug stimulant, which is alert to launch June 2007, DAYTRANAÂ (methylphenidate transdermal system), the first and single ADHD patch, and ADDERALL XRÂ (mixed salts of a single-entity amphetamine product), a long-acting formulate stimulant. Additional ADHD treatments demean than development by Shire include SPD465 (triple-bead mixed amphetamine salts) and SPD503 (guanfacine HCl extended release).
APA # NR739 Long-term Effectiveness and Safety of Lisdexamfetamine Dimesylate (LDX) in Children Aged 6 to 12 Years With Attention-Deficit/Hyperactivity Disorder APA # NR750 Improved Interpatient Pharmacokinetic Variability of Lisdexamfetamine Dimesylate Compared With Mixed Amphetamine Salts Extended Release (MAS XR) in Children Aged 6 to 12 Years With Attention-Deficit/Hyperactivity Disorder About VYVANSE and ADDERALL XR Tell your medical doctor about any heart provisos, furthermore as structural abnormality, that you, your child, or a family limit, may have. Inform your doctor right now if you or your child get it together symptoms that offer heart worries, such as casket spasm or faint.
VYVANSE or Adderall XR should not be taken by patients who have advanced illness of the blood vessel (arteriosclerosis); suggestive heart disease; moderate to severe large blood threat; overactive thyroid gland (hyperthyroidism); certain allergy or uncanny recoil to drugs call sympathomimetic amines (for case in point, pseudoephedrine); seizure; glaucoma; a precedent of problems with alcohol or drugs; agitated land; taken a monoamine oxidase inhibitor (MAOI) within the second 14 days.
Tell your doctor before using, VYVANSE or Adderall XR if you or your child are human being treat for or have symptoms of collapse (sadness, worthlessness, or hopelessness) or bipolar disorder; have nonstandard idea or delusion, hear abnormal sound, or have been diagnosed with psychosis; have have seizures or abnormal EEGs; have or have had high blood pressure; exhibit aggressive behavior or fighting. Tell your doctor immediately if any of these conditions or symptoms develop while using VYVANSE or Adderall XR.
Abuse of amphetamines may lead to trust. Misuse of amphetamine may lead to swift demise and requisite cardiovascular adverse events. These events have also been reported uncommonly with amphetamine employment.
VYVANSE and Adderall XR were generally well tolerated in clinical studies. The most common line-up effects in studies of Vyvanse incorporated: children - hurdle falling rumble asleep, stomachache, and crankiness. The most common side effects in studies of Adderall XR included: children - decreased appetite, difficulty falling asleep, stomachache, and from the heart lability; adolescents - demise of appetite, difficulty falling asleep, stomachache, and weight loss; adults - dry chops, loss of appetite, difficulty falling asleep, headache, and weight loss.
Then, one year after transplantation, patients tread to the department of Dermatology for a full-body skin study with a dermatologic surgeon who specialize in the remedy of skin cancer. If any skin cancers or pre-cancers are detect, they will be in a jiffy removed using the dominant advanced minimally interfering method to prevent doubling and reduce risk of metastatic introduce.
About DAYTRANA DAYTRANA should not be previously owned in patients with allergy to methylphenidate or patch components; well-defined anxiety, hardness and agitation; glaucoma; tics, diagnosis or a family history of Tourette's syndrome; seizures; or during or within 14 days after treatment with monoamine oxidase inhibitors (MAOIs).
Sudden death has been reported in support with CNS stimulant treatment at accepted doses in children and adolescents with structural cardiac abnormalities or other serious heart problems.
Sudden death, button, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses in ADHD. Physicians should cart a vague patient history, including family history, and physical exam, to assess the being there of cardiac disease. Patients who report symptoms of cardiac disease such as exertional chest pain and unexplained syncope should be in good time evaluated. Use with guardedness in patients whose underlying medical disorder may perhaps be mannered by accomplish in blood pressure or heart rate.
New psychosis, mania, aggression, growth suppression, and ocular disturbances have been associated with the use of stimulants. Use with caution in patients with a history of: psychosis; EEG abnormalities; bipolar disorder; depression. Growth and hematologic monitor is insist on during prolonged treatment. Patients should dissemble apply perceptible sear to the DAYTRANA patch.
Skin provocation or communication sensitization may pop your foot bleak.
DAYTRANA should be given guardedly to patients with a history of pills dependence and alcoholism. Chronic harm can lead to marked open-mindedness and psychological dependence. Frank psychotic episode can occur, mega with parenteral abuse. Careful managing is enforced during subtraction from put on ice use, since severe depression may occur. Withdrawal next incurable energizing use may unmask symptoms of the underlying disorder.
State and federal parliament have and will keep on to be making change contained by public drug pro programs, plus Medicare and Medicaid. It be indisputable that changes to public sector programs will over juncture affect payment methods employed in the private sector.
For further article of export information connected to Shire's portfolio of ADHD treatments, delight go to Vyvanse.com, AdderallXR.com, and Daytrana.com.
SHIRE PLC Shire's strategic hope is to become the prevailing specialty biopharmaceutical comradeship that focus on meeting the needs of the clout physician. Shire focuses its commercial on ADHD, human genetic therapy (HGT), gastrointestinal (GI) and renal disease. The office block is fully workable to allow Shire to target new therapeutic speciality to the degree opportunity arise through acquisition. Shire believe that a alertly chosen portfolio of products with a strategically aligned and relatively small-scale sale pull will deliver authoritative results. Shire's bold strategy is to develop and souk products for specialty physicians. Shire's in-licensing, incorporation and deed pains are focused on products in niche market with strong academic stuff trust either in the US or Europe.
For further information on Shire, please look in the Company's website: / THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts are forward-looking statement. Such forward-looking statements enmesh several risk and uncertainties and are concern to change at any time. In the occurrence such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not curbed to, risks associated with: the federal ambiguity of pharmaceutical research, product development, profession and commercialization; the impact of aggressive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patent, including but not limited to, honest challenge relating to Shire's ADHD franchise; senate authority and applause, including but not limited to the appointed product approval date of SPD503 (guanfacine extended release) (ADHD) and SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire's competency to secure new products for commercialization and/or development; Shire's ability to plus from its acquisition of New River Pharmaceuticals Inc.; and other risks and uncertainties detailed every so often in Shire plc's filings with the Securities and Exchange Commission, excitingly Shire plc's Annual Report on Form 10-K for the year terminated December 31, 2006.
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