Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lisdexamfetamine Dimesylate · 10 trials · 5 indications
Relapse status was assessed during the double-blind treatment phase and was defined as having 2 or more binge days per week for 2 consecutive weeks (14 consecutive days) prior to any visit and having an increase in Clinical Global Impressions-Severity (CGI-S) score of 2 or more points compared to the randomized-withdrawal baseline (date of relapse - date of randomization). Binge eating information was captured via a self-report paper diary. The binge diary captured the number of binges per day, total hours per day spent binging, type of binge (at mealtime or at another time other than mealtime), and a description of the binge (amounts and types of foods). Binge frequency was reviewed by the clinician with the subject to confirm reported binge episodes per day. The CGI-S was performed to rate the severity of a subject's condition using a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill).
Suicidality was assessed by using the C-SSRS, a semi-structured interview designed to capture the occurrence, severity, and frequency of suicide-related thoughts and behaviors. The interview and rating for the C-SSRS was completed by a clinician who had been successfully trained by the sponsor or designee. The interview was initiated with 5 (yes/no) questions, presented in ascending order of severity, about suicidal ideation. The most severe type of ideation was rated for frequency, duration, controllability, deterrents, and reason. If the answers to the first 2 ideation questions were "yes," the clinician asked questions 3-5. Active suicidal ideation included any participant who answered "yes" to questions 2-5. If the answers to ideation questions 1 and 2 were "no," then the clinician proceeded to 5 (yes/no) questions that addressed suicidal behavior, which was categorized as actual attempt, interrupted attempt, aborted attempt, preparatory acts or behaviors, and completed suicide.
Time to first response was defined as a Clinical Global Impression-Improvement (CGI-I) value of 1 (very much improved) or 2 (much improved) first recorded following first dose of investigational product. CGI-I consists of a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
Treatment failure defined as 50% increase (worsening) in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-IV) total score and \>= 2 point increase (worsening) in the Clinical Global Impression-Severity of Illness (CGI-S) score observed at any visit during the randomized withdrawal period compared to the respective scores at baseline of randomized withdrawal period. Subjects without an endpoint value were classed as treatment failures.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. A decrease in score indicates an improvement in ADHD symptomology.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
Binge day is defined as a day during which at least 1 binge episode occurs.
AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement.
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.
Total amphetamine is the d- and l-amphetamines.
Total amphetamine is the d- and l-amphetamines.
Total amphetamine is the d- and l-amphetamines.
Total amphetamine is the d- and l-amphetamines.
| Arm | Type | Description |
|---|---|---|
| Lisdexamfetamine dimesylate | EXPERIMENTAL | Administer one capsule (50 or 70 mg) orally daily at approximately 7:00 AM. |
| Placebo | PLACEBO_COMPARATOR | Administer one capsule orally daily at approximately 7:00 AM. |
| Atomoxetine Hydrochloride | ACTIVE_COMPARATOR | - |
| Lisdexamfetamine dimesylate (LDX) | EXPERIMENTAL | Open-label 30, 50, or 70mg |
| Methylphenidate Hydrochloride | ACTIVE_COMPARATOR | Overencapsulated Concerta 18, 36, or 54mg |
| LDX | EXPERIMENTAL | Lisdexamfetamine Dimesylate (LDX) |
| SPD489 30 mg | EXPERIMENTAL | - |
| SPD489 50 mg | EXPERIMENTAL | - |
| SPD489 70 mg | EXPERIMENTAL | - |
| Lisdexamfetamine Dimesylate Fasting | EXPERIMENTAL | lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions |
| Lisdexamfetamine Dimesylate Vanilla Yogurt | EXPERIMENTAL | Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt |
| Lisdexamfetamine Dimesylate Orange Juice | EXPERIMENTAL | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice |
| LDX + MAS-IR Placebo | ACTIVE_COMPARATOR | Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo |
| MAS-IR + LDX Placebo | ACTIVE_COMPARATOR | Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo |
| Vyvanse (LDX) | EXPERIMENTAL | - |
| Adderall XR (AXR) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Lisdexamfetamine dimesylate | DRUG | SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods) |
| Placebo | OTHER | Placebo capsule once per day (double-blind period) |
| Atomoxetine Hydrochloride | DRUG | Oral 10mg to 100mg once-daily for 9 weeks |
| Lisdexamfetamine dimesylate (LDX) | DRUG | LDX 30, 50, or 70mg capsule once per day (open-label and double-blind periods) |
| Methylphenidate Hydrochloride | DRUG | 18, 36, or 54mg tablet one per day (Overencapsulated) |
| lisdexamfetamine dimesylate (SPD489) | DRUG | SPD489-30mg capsules taken once daily for up to 11 weeks |
| Immediate Release Mixed Amphetamine Salts (MAS-IR) | DRUG | Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo |
| LDX Placebo + MAS-IR Placebo | DRUG | Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo |
| Adderall XR (mixed salts amphetamine) | DRUG | 20mg capsule |
Inclusion Criteria: 1. Subject is between 18-55 years of age, inclusive. 2. Subject meets the following criteria for a diagnosis of BED: * Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (eg, within a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
Lisdexamfetamine Dimesylate is used for Attention-Deficit/Hyperactivity Disorder (ADHD), Binge Eating Disorder, and in healthy volunteers for clinical studies. It is a small molecule being developed by Takeda Pharmaceutical Company Limited (TAK). The drug is currently in Phase 3 clinical development for these psychiatric conditions.
Lisdexamfetamine Dimesylate is a central nervous system stimulant that works by increasing the activity of neurotransmitters in the brain. It is a prodrug that is converted to dextroamphetamine, which targets the reuptake of dopamine and norepinephrine. This mechanism is thought to improve attention and reduce impulsivity in ADHD and binge eating disorder.
Lisdexamfetamine Dimesylate is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is being investigated for ADHD and Binge Eating Disorder. Takeda is conducting clinical trials to evaluate its safety and efficacy in these indications.
Lisdexamfetamine Dimesylate is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The clinical program includes completed trials in healthy volunteers, ADHD, and Binge Eating Disorder, with a total enrollment of 1,293 participants across all studies.
Lisdexamfetamine Dimesylate has been studied in several completed clinical trials. These include NCT00746733 in healthy volunteers, NCT01010750 in adults with ADHD, NCT01291173 in adults with Binge Eating Disorder, and NCT01890785 in healthy volunteers. All trials were conducted in the United States and were placebo-controlled and double-blind.
Lisdexamfetamine Dimesylate is the active ingredient in the brand-name medication Vyvanse. The clinical trials listed under the drug name include a study titled 'Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC,' indicating that Lisdexamfetamine Dimesylate is the same compound as Vyvanse.