FDA批准Shire公司ADHD新药Vyvanse上市

FDA已批准Shire公司的注意力不集中/多动症(ADHD)治疗新药Vyvanse上市，该公司计划在今年第二季度推出这种产品，该药每日用药一次，剂量分别有30毫克、50毫克和70毫克三种。

Shire负责人称，在批准函中经过审核的标签信息包括了Vyvanse药效时间长以及药物依赖等方面的内容，体现了该药与其他同类药物的区别。该公司还表示，与其他同类药物相比，Vyvanase导致药物依赖的问题相对更小。

Shire公司坚信Vyvanse的年销售额可达到10亿美元，因为美国药市对ADHD治疗药有一定的需求，美国4-17岁的儿童当中，7.8%（440万名）的人患有不同程度的ADHD。

Vyvanse is an amphetamine used to treat attention deficit disorder with hyperactivity (ADHD).

Vyvanse is used as a part of a total treatment program that may include psychological, educational, and social therapy.

Vyvanse may also be used to treat other conditions as determined by your doctor.    

Information on Vyvanse

Learn more about usage, cautions, and possible side effects .

Capsules
Chemical Name: LISDEXAMFETAMINE (lis-dex-am-FET-a-meen) 

Common uses
This medicine is an amphetamine used to treat attention deficit disorder with hyperactivity (ADHD). It is used as a part of a total treatment program that may include psychological, educational, and social therapy.

This medicine may also be used to treat other conditions as determined by your doctor.

Before using
WARNING: THIS MEDICINE HAS A HIGH RISK FOR ABUSE. It may be habit forming when used for a long period of time.

Use this medicine only as prescribed. Do not share it with others. Abuse of this medicine may cause serious heart problems, blood vessel problems, or sudden death. Some medicines or medical conditions may interact with this medicine.

INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking.

DO NOT TAKE THIS MEDICINE if you are also taking guanethidine or if you have taken furazolidone or a monoamine oxidase inhibitor (such as phenelzine) within the past 14 days.

ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking propoxyphene, tramadol, ammonium chloride, ascorbic acid (vitamin C), chlorpromazine, glutamic acid, haloperidol, lithium carbonate, methenamine, reserpine, sodium acid phosphate, sodium bicarbonate, meperidine, norepinephrine, phenobarbital, phenytoin, selective serotonin reuptake inhibitors (SSRIs) (such as fluoxetine), tricyclic antidepressants (such as desipramine), antihistamines (such as diphenhydramine), beta-blockers (such as atenolol), certain blood pressure medicines, or ethosuximide.

INFORM YOUR DOCTOR if you have had an abnormal brain wave test (EEG) or if you have any other medical conditions including a history of seizures; stroke; growth problems; thyroid problems; liver or kidney problems; recent heart attack; heart defect or other heart problems (such as heart failure, heart rhythm problems); blood vessel problems; blood problems (such as porphyria); fast or irregular heartbeat; high blood pressure; allergies; pregnancy; or breast-feeding.

INFORM YOUR DOCTOR if you have a family history or sudden death or heart rhythm problems.

INFORM YOUR DOCTOR if you have a personal or family history of Tourette syndrome, uncontrolled muscle movements (such as tics), mental or mood problems, or suicidal thoughts or attempts.

USE OF THIS MEDICINE IS NOT RECOMMENDED if you have had an unusual reaction to a sympathomimetic medicine (such as methylphenidate, pseudoephedrine) including a fast or irregular heartbeat, overexcitement, or severe trouble sleeping.

USE OF THIS MEDICINE IS NOT RECOMMENDED if you have certain blood vessel problems (such as hardening of the arteries); heart problems; moderate, severe, or uncontrolled high blood pressure; high blood pressure in the lungs; anorexia; an overactive thyroid; increased pressure in the eye; glaucoma; serious heart defects; serious abnormal heart rhythm; an enlarged heart; agitation, anxiety, or tension; or a history of alcohol or other substance abuse.

USE OF THIS MEDICINE IS NOT RECOMMENDED IN CHILDREN who are younger than 3 years old. Discuss with your doctor the risks and benefits of giving this medicine to your child.

Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

Directions
Follow the directions for using this medicine provided by your doctor.

This medicine comes with a Medication Guide. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

TAKE THIS MEDICINE BY MOUTH in the morning with or without food.

THIS MEDICINE MAY BE TAKEN WITH FOOD if it upsets your stomach. Swallow this medicine whole.

Do not break, crush, or chew before swallowing. If you cannot swallow the capsule whole, you may open it and dissolve the contents of the capsule in an 8oz (240 mL) glass of water. Drink the mixture right away. Do not store the mixture for future use.

STORE THIS MEDICINE at room temperature 77 degrees F (25 degrees C), in a tightly-closed container, away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted.

IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. 

Cautions
DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it, to sympathomimetic medicines (such as methylphenidate or pseudoephedrine), or if you are allergic to any ingredient in this product.

IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval.

When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well.

DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor.

Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming or cause other serious side effects. Laboratory and/or medical tests, including blood pressure and heart rate may be performed to monitor your progress or to check for side effects.

KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine.

THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS, including corticosteroid levels.

Make sure laboratory personnel and your doctors know you use this medicine.

BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. Amphetamines may affect growth rate in children and adolescents in some instances. Your child's growth should be checked regularly while using this medicine.

This medicine may cause dizziness or blurred vision.

DO NOT DRIVE, OPERATE MACHINERY, or do anything else that could be dangerous until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.

THIS MEDICINE MAY CAUSE SLEEPLESSNESS. Do not take this medicine near your bedtime unless your doctor tells you otherwise.

AVOID LARGE AMOUNTS OF caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate. Caffeine can increase the side effects of this medicine.

BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist.

CAUTION IS ADVISED WHEN USING THIS MEDICINE IN CHILDREN because they may be more sensitive to the effects of the medicine.

 FOR WOMEN: This medicine may cause harm to the fetus.

IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy.

THIS MEDICINE IS EXCRETED IN BREAST MILK. DO NOT BREAST-FEED while taking this medicine.

Possible side effects
SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; dry mouth; headache; decreased appetite; nausea; mild irritability, nervousness, or restlessness; trouble sleeping; unpleasant taste; upper stomach pain; vomiting; and weight loss. If they continue or are bothersome, check with your doctor.

CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience unusual weakness or tiredness, or a change in sexual ability or desire.

CONTACT YOUR DOCTOR IMMEDIATELY if you experience agitation; blurred vision or other vision changes; chest pain; fainting; fast or irregular heartbeat; fever; hallucinations; new or worsening mental or mood changes; seizures; severe or persistent headache; severe or persistent irritability, nervousness, or restlessness; shortness of breath; tremor; or uncontrolled speech or muscle movements (such as tics). An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other.
If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately.

Symptoms of overdose may include severe mental or mood changes; confusion; severe restlessness; fast breathing; hallucinations; irregular heartbeat; seizures; fever; severe or persistent headache, nausea, or diarrhea; or vomiting.

Additional information
IF YOU ARE TAKING THIS MEDICINE for ADHD or ADD and your symptoms do not improve or if they become worse, check with your doctor.

DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed.

DO NOT USE THIS MEDICINE for other health conditions.

KEEP THIS MEDICINE out of the reach of children.

IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain a new prescription from your doctor before your supply runs out.

July 28, 2007

Vyvanse Available in Pharmacies

Shire's New ADHD medication, VYVANSE™ (lisdexamfetamine dimesylate) Now Available in U.S. Pharmacies Nationwide Clinical study demonstrated efficacy until 6pm; May be of interest to mothers of children with ADHD

Philadelphia, PA– July 27, 2007– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that VYVANSE (lisdexamfetamine dimesylate), a new once-daily medication approved to treat the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), is now available in U.S. pharmacies nationwide. In a clinical study, VYVANSE provided consistent ADHD symptom control throughout the day based upon parent reports in the morning (approximately 10am), afternoon (approximately 2pm), and early evening (approximately 6pm).

This may be of interest to mothers of children with ADHD based on a recent survey of 121 mothers of ADHD children aged 6 to 12 years, in which 60 percent of mothers reported that their child’s ADHD medication stopped working before 6pm and 40 percent reported that their child’s ADHD medication stopped working before 4pm.

"VYVANSE was shown in clinical studies to provide physicians with a treatment option for ADHD that offers consistent and effective control of ADHD symptoms throughout the day for up to 12 hours, from morning through homework and family time," said Frank A. López, M.D., of the Children’s Developmental Center in Winter Park, Fla. "Consistent symptom control throughout the day is important because kids have homework and after-school activities that require the same concentration and focus needed during the school day."

This new ADHD medication, VYVANSE, works with the patient's natural metabolism to deliver active medication and significantly improves core ADHD symptoms of inattention (e.g. focus, listening to, and following instructions) and behavior (hyperactivity and impulsivity).

"I know that my son, Kevin, has unique talents and abilities.

When his ADHD symptoms were consistently controlled throughout the day, others could see the wonderful, talented boy that I see," said Rachel May, mother of Kevin Dixon, Jr. "After my son started taking VYVANSE in a clinical trial, I saw a difference in Kevin within the first week; others saw it, too."

The U.S. Food and Drug Administration (FDA) approved VYVANSE on February 23, 2007.

VYVANSE is now available in retail pharmacies in 30 mg, 50 mg and 70 mg dosage strengths.

About VYVANSE
In the phase III, randomized, double-blind placebo-controlled study, all three doses of VYVANSE demonstrated significant improvements in ADHD Rating Scale (ADHD-RS-IV) scores compared with placebo (P <.0001) after four weeks of once-daily treatment. ADHD-RS-IV is a standardized, validated test for assessing symptoms of ADHD in children and for assessing their response to treatment. The effects were maintained throughout the day based on parent ratings reported at approximately 10 am, 2 pm, and 6 pm using the Connors' Parent Rating Scale (CPRS).

The CPRS rates a child's behavior at home and in other environments where the parent has the opportunity to observe the child.

The most common side effects reported in this study were decreased appetite, difficulty falling asleep, stomachache, and irritability.

Additional information about VYVANSE, Full Prescribing Information, and Medication Guide are available at

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 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 symptomsofinattention;and/oratleastsixofninesymptomsofhyperactivity/impulsivity; the onset of which appears 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 and the symptoms cannot be better explained by another psychiatric disorder.

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.

Important Safety Information
Tell the doctor about any heart conditions, including structural abnormalities, that you, your child, or a family member, may have. Inform the doctor immediately if your child develops symptoms that suggest heart problems, such as chest pain or fainting.

VYVANSE should not be taken if your child has advanced disease of the blood vessels (arteriosclerosis); symptomatic heart disease; moderate to severe high blood pressure; overactive thyroid gland (hyperthyroidism); known allergy or unusual reactions to drugs called sympathomimetic amines (for example, pseudoephedrine); seizures; glaucoma; a history of problems with alcohol or drugs; agitated states; taken a monoamine oxidase inhibitor (MAOI) within the last 14 days.

Tell the doctor before taking VYVANSE if your child is being treated for or has symptoms of depression (sadness, worthlessness, or hopelessness) or bipolar disorder; has abnormal thought 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 the doctor immediately if your child develops any of these conditions or symptoms while taking VYVANSE.

Abuse of amphetamines may lead to dependence. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.

These events have also been reported rarely with amphetamine use.

VYVANSE was generally well tolerated in clinical studies.

The most common side effects reported in studies of VYVANSE were decreased appetite, difficulty falling asleep, stomachache, and irritability.
Aggression, new abnormal thoughts/behaviors, mania, growth suppression, worsening of motion or verbal tics, and Tourette's syndrome have been associated with use of drugs of this type.

Tell the doctor if your child has blurred vision while taking VYVANSE.

Shire plc
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.

Shire focuses its business on 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: 

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 date of INTUNIV™ (guanfacine) extended release (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire's ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTA® (human TGFâ3) and other risks and uncertainties detailed from time to time in Shire 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, 2006. 

Shire向FDA申请Vyvanse用于治疗成人ADHD
 
 在Vyvanse刚刚通过批准用于治疗儿童ADHD（注意力不集中/多动症）后不久，英国Shire公司又向FDA申请该药用于成人ADHD患者，目前这份补充新药申请已经递交，审批时间预计为10个月。

 Shire主要负责人表明，人们对于“儿童或成人均有可能患上ADHD，而这种疾病可以治愈”的认识非常重要，Vyvanse用于成人患者的III期临床实验数据将于今年第四季度对外公布。

 Shire已在美国销售该药，它目前仅用于6-12岁儿童患者。该公司发言人称，Shire公司希望一直使用其同类畅销药Adderall XR的患者转而使用Vyvanse进行治疗，前者的专利保护将于2009年失效，这样有助于该公司抢占ADHD药市场份额。

 这名发言人还表示，Vyvanse的售价与Adderall XR相同，但为了让患者转用新药，它的价格有可能下降。Shire坚信Vyvanse能在众多的ADHD药中脱颖而出，因为该药药效保持时间更长，也不轻易造成药物滥用。