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Vyvanse (LISDEXAMFETAMINE)
Vyvanse (generic name: LISDEXAMFETAMINE) is a Central Nervous System Stimulant Small molecule drug developed by Takeda. It is currently FDA-approved (first approved 2007) for Attention Deficit Hyperactivity Disorder (ADHD), Moderate to severe binge eating disorder (BED).
Vyvanse works by blocking the dopamine transporter, allowing more dopamine to be available in the brain.
Vyvanse, a small molecule medication, is used to treat conditions such as bipolar depression, binge eating disorder, and schizophrenia, among others. It is available in the form of an oral tablet, typically compared to a placebo in clinical trials.
At a glance
| Generic name | LISDEXAMFETAMINE |
|---|---|
| Sponsor | Takeda |
| Drug class | Central Nervous System Stimulant |
| Target | Sodium-dependent dopamine transporter |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2007 |
| Annual revenue | 3200 |
Mechanism of action
Lisdexamfetamine is prodrug of dextroamphetamine. After oral administration, lisdexamfetamine is rapidly absorbed from the gastrointestinal tract and converted primarily in blood due to the hydrolytic activity of red blood cells to dextroamphetamine, which is responsible for the drugs activity. Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space. The parent drug, lisdexamfetamine, does not bind to the sites responsible for the reuptake of norepinephrine and dopamine in vitro.
Approved indications
- Attention Deficit Hyperactivity Disorder (ADHD)
- Moderate to severe binge eating disorder (BED)
Boxed warnings
- WARNING: ABUSE, MISUSE, AND ADDICTION Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing lisdexamfetamine dimesylate capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout lisdexamfetamine dimesylate capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1 ), and Drug Abuse and Dependence (9.2) ]. WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. Lisdexamfetamine dimesylate capsules have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including lisdexamfetamine dimesylate capsules, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing lisdexamfetamine dimesylate capsules, assess each patient's risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient's risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
Common side effects
- Decreased appetite
- Upper abdominal pain
- Vomiting
- Weight decreased
- Nausea
- Dry mouth
- Dizziness
- Irritability
- Insomnia
- Anxiety
- Dyspnea
- Fatigue
Drug interactions
- Acidifying Agents
- Alkalinizing Agents
- MAO Inhibitors (MAOI)
- Serotonergic Drugs
- CYP2D6 Inhibitors
- Tricyclic Antidepressants
Key clinical trials
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder (PHASE2)
- Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users (PHASE2)
- Pharmacological and Behavioral Treatment After Bariatric Surgery: Medication Change for Non-Responders (Stage 2b) (PHASE2,PHASE3)
- Vyvanse in Children Aged 6 to 12 Years (EARLY_PHASE1)
- Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment (PHASE3)
- Efficacy and Safety of Tirzepatide Versus Placebo or Lisdexamfetamine Dimesylate for Binge-Eating Disorder (PHASE2)
- Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vyvanse CI brief — competitive landscape report
- Vyvanse updates RSS · CI watch RSS
- Takeda portfolio CI
Frequently asked questions about Vyvanse
What is Vyvanse?
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When was Vyvanse approved?
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Related
- Drug class: All Central Nervous System Stimulant drugs
- Target: All drugs targeting Sodium-dependent dopamine transporter
- Manufacturer: Takeda — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Attention Deficit Hyperactivity Disorder (ADHD)
- Indication: Drugs for Moderate to severe binge eating disorder (BED)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing