Vyvanse (Lisdexamfetamine)is a stimulant medication for the treatment of ADHD. VYVANSE is a prodrug that is therapeutically inactive until metabolized in the body. In clinical studies designed to measure duration of effect, VYVANSE provided significant efficacy compared to placebo for a full treatment day, up through and including 6:00 pm. Furthermore, when VYVANSE was administered orally and intravenously in two clinical human drug abuse studies, VYVANSE produced subjective responses on a scale of “Drug Liking Effects” (DLE) that were less than d-amphetamine at equivalent doses. DLE is used in clinical abuse studies to measure relative preference among known substance abusers.
Shire Pharmaceuticals received approval on their third medication for the treatment of ADHD named VYVANSE, to go along with ADDerall XR and Daytrana. All three ADHD drugs are once a day dosing. As we reported in 2007, Shire paid New River Pharmaceuticals $2.6 Billion in cash to partner with them in the production and marketing of Vyvanse for ADHD. Randal J. Kirk, New River’s Chairman and Chief Executive Officer, remarked, “VYVANSE’s approval signals a new era in the treatment of ADHD. Upon product launch, patients will have a novel treatment option combining the effectiveness of a stimulant – long considered the gold standard in ADHD medicines – with other potential benefits.”
VYVANSE will be available in three dosage strengths: 30 mg, 50 mg and 70 mg, all indicated for once-daily dosing.
New River developed VYVANSE as a new ADHD medication designed to provide lower potential for abuse, in which d -amphetamine is covalently linked to l -lysine, a naturally occurring amino acid. The combination is rapidly absorbed from the gastrointestinal tract and converted to d -amphetamine, which is responsible for VYVANSE’s activity.
Joseph Biederman, MD, director of Pediatric Psychopharmacology at Massachusetts General Hospital, was lead investigator on the pivotal clinical studies testing lisdexamfetamine dimesylate for the treatment of ADHD. These large multi-site studies showed that the drug significantly reduced ADHD symptoms throughout the day with a predictable tolerability profile. “Our studies showed that this next-generation stimulant medication's unique chemical profile offers an option for physicians and their patients in the treatment of ADHD, with outstanding efficacy and duration of action” said Dr. Biederman.
We want to like this medication, but after reading the side effects and warnings, it is hard to want to encourage people to take this medication. We hold out hope for the future of prodrugs, but we may not be there yet. Read on...
Some side effects can be serious. If you experience any of these symptoms call your doctor immediately:
Vyvanse (Lisdexamfetamine) may cause sudden death in children and teenagers, especially children and teenagers who have heart defects or serious heart problems. This medication also may cause sudden death, heart attack or stroke in adults, especially adults who have heart defects or serious heart problems. Talk to your doctor about the risks of taking this medication.
Lisdexamfetamine may slow children's growth or weight gain. Your child's doctor will watch his or her growth carefully. Talk to your child's doctor if you have concerns about your child's growth or weight gain while he or she is taking this medication. Talk to your child's doctor about the risks of giving lisdexamfetamine to your child.
Lisdexamfetamine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [ 1-800-332-1088 1-800-332-1088].
Warning Vyvanse (Lisdexamfetamine) can be habit-forming. Do not take a larger dose, take it more often, take it for a longer time, or take it in a different way than prescribed by your doctor. If you take too much lisdexamfetamine, you may find that the medication no longer controls your symptoms, you may feel a need to take large amounts of the medication, and you may experience symptoms such as rash, difficulty falling asleep or staying asleep, irritability, hyperactivity, and unusual changes in your personality or behavior. Overusing lisdexamfetamine may also cause sudden death or serious heart problems, such as heart attack or stroke.
Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications. Your doctor will probably not prescribe lisdexamfetamine for you.
Do not stop taking lisdexamfetamine without talking to your doctor, especially if you have overused the medication. Your doctor will probably decrease your dose gradually and monitor you carefully during this time. You may develop severe depression and extreme tiredness if you suddenly stop taking lisdexamfetamine after overusing it.
We always recommend trying our ADHD eating program, Essential Fatty Acids, and ATTEND and/or EXTRESS first, depending on what type of ADHD one has.
This book section: ADHD Medications
Douglas Cowan, Psy.D., MFT is a licensed Marriage and Family Therapist in Tehachapi, CA who has been a counselor to children, teens, and adults helping them to overcome ADHD, find relief for depression or anxiety, and solve other problems in life since 1989. He served on the medical advisory board to the company that makes Attend and Extress from 1997 through 2011, and he is the Editor of the ADHD Information Library online resource at http://newideas.net/. His weekly ADHD Newsletter goes out to 9,500 families. Visit his website at http://DouglasCowan.me for more information on achieving greater health, personal growth, Christ-centered spirituality, stress management, parenting skills, ADHD, working out the stresses of being a care-giver to elderly parents and also being a parent to teenagers, or finding greater meaning in retirement years, Dr. Cowan can be a valuable resource to you.
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Douglas Cowan, Psy.D., MFT
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