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AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.
MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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VYVANSE SUMMARY
Vyvanse™ (lisdexamfetamine dimesylate) C-II Rx Only
Vyvanse (lisdexamfetamine dimesylate) is designed as a capsule for once-a-day oral administration. The chemical designation for lisdexamfetamine dimesylate is (2S)-2,6-diamino- N -[(1 S)-1-methyl-2-phenylethyl]hexanamide dimethanesulfonate.
Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
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NEWS HIGHLIGHTSMedia Articles Related to Vyvanse (Lisdexamfetamine)
Shire Reports Analysis Examining Emotional Lability In Children With ADHD Taking Vyvanse
Source: ADHD News From Medical News Today [2009.11.14]
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.
Shire Reports Findings From An Analysis Examining Emotional Lability In Children With ADHD Taking Vyvanse(R) (lisdexamfetamine Dimesylate) Capsules
Source: ADHD News From Medical News Today [2009.11.13]
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced findings from a post hoc analysis examining emotional lability from Phase 3 study data with Vyvanse®. In this study, Vyvanse demonstrated significant improvement in Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms as measured by the ADHD Rating Scale IV (ADHD-RS IV) and Connors' Parent Rating Scale-Revised Short (CPRS-RS) in children with ADHD aged 6 to 12 years.
ADHD: Vyvanse Capsules CII Administration Through 2 Routes Demonstrated Similar Pharmacokinetic Profile
Source: ADHD News From Medical News Today [2009.10.24]
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally.
New Study On Vyvanse(R) (lisdexamfetamine Dimesylate) Capsules CII Shows Administration Of Vyvanse Through Two Different Routes
Source: ADHD News From Medical News Today [2009.10.23]
Shire plc (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, announced new data about the pharmacokinetics of its Attention-Deficit/Hyperactivity Disorder (ADHD) medication, Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, which showed that Vyvanse provided similar concentrations of its active medication in the blood when administered either intranasally or when administered orally.
Study Findings On ADHD Treatments Presented At Psychiatric Meeting
Source: ADHD News From Medical News Today [2009.10.30]
Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, has announced that it will present key scientific data on its Attention-Deficit/Hyperactivity Disorder (ADHD) treatments, INTUNIV™ (guanfacine) Extended Release Tablets, Vyvanse® (lisdexamfetamine dimesylate) Capsules CII, and Daytrana® (methylphenidate transdermal system) CII, at a national meeting of psychiatrists being held October 27 - November 1 in Honolulu.
Published Studies Related to Vyvanse (Lisdexamfetamine)
A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. [2009.06.09]
ABSTRACT: BACKGROUND: Lisdexamfetamine dimesylate (LDX) is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children 6 to 12 years of age and in adults. In a previous laboratory school study, LDX demonstrated efficacy 2 hours postdose with duration of efficacy through 12 hours. The current study further characterizes the time course of effect of LDX... CONCLUSION: In school-aged children (6 to 12 years) with ADHD, efficacy of LDX was maintained from the first time point (1.5 hours) up to the last time point assessed (13.0 hours). LDX was generally well tolerated, resulting in typical stimulant AEs. TRIAL REGISTRATION: Official Title: A Phase IIIb, Randomized, Double-Blind, Multi-Center, Placebo-Controlled, Dose-Optimization, Cross-Over, Analog Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With Attention-Deficit/Hyperactivity Disorder.ClinicalTrials.gov Identifier: NCT00500149http://clinicaltrials.gov/ct2/show/NCT00500149.
Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. [2009.06]
Lisdexamfetamine dimesylate (LDX) is the first prodrug stimulant and is indicated for the treatment of attention-deficit/hyperactivity disorder. A single-centre, double-blind, randomised, placebo-controlled, 6-period crossover study evaluated the abuse potential of single oral doses of 50, 100 (equivalent to 40 mg d-amphetamine), and 150 mg LDX, 40 mg d-amphetamine and 200 mg diethylpropion in 36 individuals with a history of stimulant abuse...
Effect of lisdexamfetamine dimesylate on parent-rated measures in children aged 6 to 12 years with attention-deficit/hyperactivity disorder: a secondary analysis. [2008.09]
To evaluate the efficacy of lisdexamfetamine dimesylate (LDX) in school-aged children with attention-deficit/hyperactivity disorder (ADHD), using the Conners' Parent Rating Scale, Revised Short Version (CPRS-R:S) and its subscales... CONCLUSION: Once-daily treatment with LDX was associated with significant improvement in parent-rated assessments of ADHD-related behavior throughout the day at approximately 10:00 AM, 2:00 PM, and 6:00 PM. Lisdexamfetamine dimesylate was effective and well tolerated in this study population of children aged 6 to 12 years with ADHD.
Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. [2008.09]
CONCLUSION: All 3 lisdexamfetamine doses were significantly more effective than placebo in the treatment of adults with ADHD, with improvements noted within 1 week. Lisdexamfetamine was generally well tolerated by these patients. Copyright 2008 Physicians Postgraduate Press, Inc.
Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: a single-dose, crossover pharmacokinetic study. [2008.03]
The relative bioavailability of oral lisdexamfetamine dimesylate, a prodrug of d-amphetamine, and active d-amphetamine was assessed in an open-label, single-dose, 3-treatment, 3-period, randomized, crossover study in 18 healthy adult volunteers. Following a fast of at least 10 hours, subjects were administered an intact capsule of 70 mg lisdexamfetamine, a solution containing the capsule contents, or an intact capsule with a high-fat meal...
Clinical Trials Related to Vyvanse (Lisdexamfetamine)
Dose-Optimization Study Evaluating the Efficacy, Safety and Tolerability of Vyvanse (Lisdexamfetamine Dimesylate) in Children Aged 6-12 Diagnosed With ADHD [Completed]
Assess the efficacy & tolerability of Vyvanse when children aged 6-12 years diagnosed with
ADHD are dosed to optimal effect.
A Classroom Study to Assess the Time of Onset of Vyvanse (Lisdexamfetamine Dimesylate) in Pediatric Subjects Aged 6-12 With ADHD [Completed]
The primary objective of this study is to assess the time of onset of Vyvanse compared to
placebo, in the analog classroom as measured by the Swanson, Kotkin, Agler, M. Flynn and
Pelham (SKAMP) deportment scale in children (aged 6-12) diagnosed with
Attention-Deficit/Hyperactivity Disorder (ADHD).
Safety, Tolerability and Abuse Liability Study of Intravenous NRP104 in Adults With Stimulant Abuse Histories [Completed]
This research is being done to evaluate if NRP 104 is a safe drug. The other purpose is to
learn if NRP104, when injected into a vein, produces a high and any other effects like
amphetamine and other stimulant drugs that are abused. This information will give some
indication if NRP104 can be abused. Healthy people, between the ages of 18 and 55 with
histories of substance abuse that include stimulant drugs, may join. Amphetamines are drugs
that are used most often to treat attention deficit hyperactivity disorder (ADHD) in
children, to treat narcolepsy (excessive sleepiness) and for weight loss.
Study to Evaluate the Likeability, Safety, and Abuse Potential of NRP 104 in Adults With Histories of Stimulant Abuse [Completed]
This research is being done to evaluate if NRP104 is a safe drug. The other purpose is to
learn if NRP104 produces a high and any other effects like amphetamine and other stimulant
drugs that are abused. This information will give some indication if NRP104 can be abused.
NRP104 is an investigational drug. This means that it has not been approved by the U. S. Food
and Drug Administration (FDA). Healthy people, between the ages of 18 and 55 with histories
of substance abuse that include stimulant drugs, may join. Amphetamines are drugs that are
used most often to treat attention deficit hyperactivity disorder (ADHD) in children, to
treat narcolepsy (excessive sleepiness) and for weight loss.
An In Depth Cardiovascular Study of Lisdexamfetamine (LDX; Vyvanse) in Healthy and Treated Hypertensive Adults With Attention Deficit Hyperactivity Disorder (ADHD) [Recruiting]
The purpose of this research study is to learn about the effects of a medication called
Vyvanse on the heart (cardiovascular system). The U. S. Food and Drug Administration (FDA)
has approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
People who have ADHD have trouble paying attention, organizing, and planning; these symptoms
can cause problems at work, socially and at home.
Vyvanse (also known as Lisdexamfetamine) is an amphetamine (a stimulant). Amphetamines
increase alertness and activity. They are considered safe and effective for treating ADHD
in children. Less is known about the safety and effectiveness of stimulants when they are
used to treat adults with ADHD. There have been some reports of sudden death in children
and adults treated with stimulants. There is no definite evidence that the deaths were
related to the use of stimulants. However, the deaths have raised questions about the
effects that stimulants might have on such things as blood pressure and heart rate.
The study will involve measuring your blood pressure both at home and in the office as well
as cardiovascular tests at the main campus of MGH. The cardiovascular tests involved in the
study are the echocardiograph (ultrasound of the heart) and cardiopulmonary exercise test
(also called stress test; subjects exercise on a bicycle while measuring their heart
activity and breathing is monitored by cardiologists).
We predict to see changes in blood pressure and heart rate (average increase of heart rate
3-7 bpm, 1-5 mmHg blood pressure) as shown in other clinical studies. We predict that
cardiovascular tests, such as the stress test, will show higher resting heart rate and lower
heart rate recovery during exercise on LDX in comparison to exercise off LDX. However, we do
not expect to see any changes in heart and lung functioning on LDX as compared to off LDX.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 9 ratings/reviews, Vyvanse has an overall score of 8.22. The effectiveness score is 8.67 and the side effect score is 7.78. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Vyvanse review by 44 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | ADD |
| Dosage & duration: | | 70 miligrams (dosage frequency: 1 daily) for the period of 4 months |
| Other conditions: | | none |
| Other drugs taken: | | wellbutrin | | |
Reported Results |
| Benefits: | | Helps with concentration and staying focused. Helps to keep me from being hyperactive and fidgety and helps with memory to an extent. |
| Side effects: | | If I am stressed, I seem to be jittery and the benefits are not as prominent. |
| Comments: | | I was diagnosed with ADD three years ago. Have tried several different prescriptions and found the best results from Adderall and Vyvanse. |
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| | Vyvanse review by 49 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | attention issues, to much to do/ too little time |
| Dosage & duration: | | 40mg taken 1x daily in am for the period of 6 months and counting |
| Other conditions: | | stress, inability to stay on task, worried |
| Other drugs taken: | | none but vitamins | | |
Reported Results |
| Benefits: | | I was able to create a tasks list, complete the list in full and stay focused for a full days work, and not get sidetracked or feel the least bit tired.
Day after day, I continued to work better than I had been able to for years. |
| Side effects: | | Lack of appetite was a problem at first. Edgy when the medicatin is wearing down (10 hours after taking.) |
| Comments: | | Had to go to a psychiatrist to get it prescribed. Check ups every 3 months to determine effectiveness. So far everything is a go! I cannot express how this has changed my life! |
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| | Vyvanse review by 37 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Ineffective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | add |
| Dosage & duration: | | 30mg taken daily for the period of 2 weeks |
| Other conditions: | | na |
| Other drugs taken: | | na | | |
Reported Results |
| Benefits: | | Slight eurphoria and "high" felt good but not what I was trying to treat |
| Side effects: | | aggravated acne, short term memory loss, loss of cognitive abilities |
| Comments: | | Most recently diagnosed with adult add, never tried add medications before. Tried to give it time to work as many people say side effects get better but could not deal with the major facial skin breakouts. |
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Page last updated: 2009-11-14
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