Dyanavel XR (amphetamine XR) / Tris Pharma - LARVOL DELTA

A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD). (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Rochester Center for Behavioral Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fatigue • Psychiatry

Economic Evaluation of a Novel Treatment of Attention-Deficit/Hyperactivity Disorder in US Motor Vehicle Drivers. (PubMed, J Health Econ Outcomes Res) - "DYANAVEL XR (DXR) (Tris Pharma, Inc.) is a once-daily fast-acting amphetamine developed for ADHD treatment... Outcomes suggest that DXR may be an economically beneficial treatment compared with SOC for ADHD patients. The economic model showed that DXR is cost-saving compared with no treatment and SOC by reducing the number of motor vehicle crashes in the ADHD population."

HEOR • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD). (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Rochester Center for Behavioral Medicine | Initiation date: May 2024 ➔ Aug 2024

Trial initiation date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fatigue • Psychiatry

Economic evaluation of DYANAVEL XR for the treatment of attention-deficit/hyperactivity disorder in US motor vehicle drivers (AMCP 2024) - "The economic model shows that DXR is cost-saving compared with untreated patients and SOC- treated patients by reducing the number of motor vehicle crashes in the ADHD population."

HEOR • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD). (clinicaltrials.gov) - P4 | N=50 | Not yet recruiting | Sponsor: Rochester Center for Behavioral Medicine

New P4 trial • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Fatigue • Psychiatry

Efficacy of Amphetamine Extended-Release Oral Suspension in Children with Attention-Deficit/Hyperactivity Disorder: Effect Size Across the Day. (PubMed, J Child Adolesc Psychopharmacol) - P3 | " AMPH EROS demonstrated a large and consistent effect size across the day, including early in the morning, in the treatment of symptoms of ADHD in children aged 6-12 years. Trial Registration: clinicaltrials.gov identifier: NCT02083783."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Tris Pharma Announces Continued Supply and Availability of DYANAVEL XR (amphetamine) Tablets and Oral Suspension for ADHD Despite Adderall shortage (PRNewswire) - "Tris Pharma...announced today that DYANAVEL® XR (amphetamine) extended-release tablets, for oral use, CII and DYANAVEL® XR (amphetamine) extended-release oral suspension, CII are stocked by wholesalers and continue to be available in pharmacies. DYANAVEL XR was approved by the U.S. Food and Drug Administration for the treatment of Attention- Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older. Dyanavel XR may be an option for health care providers and patients who can no longer fill their prescription of Adderall due to a stocking shortage."

Commercial • Attention Deficit Hyperactivity Disorder • CNS Disorders

Effect of a Single Dose of Amphetamine Extended-Release Tablet on Driving Performance in Young Adult Drivers With ADHD: A Randomized, Double-Blind, Placebo-Controlled Study Using a Laboratory Driving Environment (AACAP 2022) - "Single dose of AMPH ER was well-tolerated with no drop-outs due to adverse events (AEs), no serious AEs or deaths. Conclusions Drivers with ADHD who took AMPH ER showed improved behavior in the driving simulation associated with a lower crash risk relative to subjects who took placebo."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. (PubMed, J Clin Psychiatry) - P3 | " AMPH ER TAB demonstrated efficacy in treatment of symptoms of ADHD in adults, with an anticipated safety profile. Trial Registration: ClinicalTrials.gov identifier: NCT03834766."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder • Xerostomia

Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet in Adults with Attention-Deficit/Hyperactivity Disorder. (PubMed, CNS Spectr) - "The AMPH ER TAB demonstrated efficacy in the treatment of symptoms of ADHD in adults, with an anticipated safety profile."

Clinical • Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Behavior Disorders • CNS Disorders • Insomnia • Mental Retardation • Psychiatry • Sleep Disorder • Xerostomia

Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: Tris Pharma, Inc. | Recruiting ➔ Completed | N=30 ➔ 41

Enrollment change • Trial completion • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

[VIRTUAL] The Efficacy and Safety of Amphetamine Extended-release Oral Suspension (AMPH EROS) in Children with Attention-deficit/hyperactivity Disorder (AAP-NCE 2021) - "AMPH EROS was effective in reducing symptoms or ADHD from 1 to 13 hours after dosing. Adverse events reported were consistent with those of other amphetamine products."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Pain • Pediatrics • Psychiatry • Sleep Disorder

Assessing Palatability of a New Amphetamine Extended-Release Tablet Formulation for the Treatment of ADHD. (PubMed, Drug Des Devel Ther) - "The positive palatability data presented here will be useful for future "real-world" assessments of adherence to treatment with the AMPH ER TAB. Enhanced adherence may bolster the argument that taste, mouthfeel, and aftertaste are critical determinants of treatment adherence."

Journal • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Comparative Bioavailability of Amphetamine Extended-Release Oral Suspension and Extended-Release Mixed Amphetamine Salts. (PubMed, CNS Spectr) - "The bioavailability of a single 7.5 mL dose of AMPH EROS 2.5 mg/mL was comparable to a single 30 mg capsule dose of ER MAS. AMPH EROS (both d- and l-amphetamine) showed equivalent peak and overall exposure to ER MAS under fasted conditions."

Journal

Single-Dose Pharmacokinetics of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in 6-12-Year-Old Children with ADHD. (PubMed, CNS Spectr) - "This study confirmed that the PK profile of AMPH EROS in 6 to 12-year-olds provided a consistent, predictable extended-release profile in a highly titratable liquid formulation, and this finding was relatively consistent and directionally predictable between the age groups assessed, with higher maximum concentrations and AUCs and shorter elimination half-lives noted in the younger population, with no anomalous parameters demonstrated, and no untoward or unexpected safety issues noted."

Clinical • Journal • PK/PD data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Single-Dose Pharmacokinetics of Amphetamine Extended-Release Oral Suspension in Healthy Adults. (PubMed, J Atten Disord) - "The bioavailability of a single dose of AMPH EROS was comparable to two 15 mg doses of IR MAS, given 4 hr apart, with no food effect or safety concerns observed."

Clinical • Journal • PK/PD data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Psychiatry

[VIRTUAL] Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel Group Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet (AMPH ER TAB) in Adults with ADHD (ASCP 2021) - "The AMPH ER TAB demonstrated efficacy in treatment of symptoms of ADHD in adults, with an anticipated safety profile. Learning Objectives 1. Learn the efficacy and safety profile of a new therapeutic option for patients with ADHD."

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder

[VIRTUAL] Comparative Bioavailability of Amphetamine Extended-Release Oral Suspension and Extended-Release Mixed Amphetamine Salts (CPNP 2021) - "Previously Presented: 2020 US Psych Congress"

[VIRTUAL] Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel Group Study to Evaluate the Efficacy and Safety of the Amphetamine Extended-Release Tablet (AMPH ER TAB) in Adults with Attention-Deficit/Hyperactivity Disorder (CPNP 2021) - "Previously Presented: 2021 APSARD Meeting"

Clinical • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Amphetamine Extended Release Tablets and Driving Performance in Subjects With Attention Deficit/Hyperactivity Disorder (ADHD) (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Tris Pharma, Inc.; Not yet recruiting ➔ Recruiting

Enrollment open • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

[VIRTUAL] Palatability Assessment of a New Amphetamine Extended-Release Tablet Formulation (AACAP 2020) - No abstract available

[VIRTUAL] Pharmacokinetics of Amphetamine Extended-Release Oral Suspension (AMPH EROS) in Adolescents Interpolated From Children and Adults Using Population Analysis (AACAP 2020) - No abstract available

Clinical • PK/PD data

[VIRTUAL] Single-Dose Pharmacokinetics of Amphetamine Extended-Release Tablet (AMPH Er TAB) Compared With Amphetamine Extended-Release Oral Suspension (AMPH EROS) (ASCP 2020) - "The bioavailability of AMPH ER TAB for both d- and l-amphetamine was determined to be comparable, swallowed whole or chewed, to an equivalent 20 mg dose of the reference product AMPH EROS, 2.5 mg/mL fasted, and showed equivalent peak and overall exposure, without any apparent food effect. All AEs were mild in severity and the overall safety profile was similar to other amphetamine formulations used for ADHD. Learning Objectives: Provide relevant clinical data on a new option for treatment of ADHD in children and adults."

PK/PD data • Attention Deficit Hyperactivity Disorder • CNS Disorders

[VIRTUAL] Palatability Assessment of a New Amphetamine Extended-Release Tablet Formulation (ASCP 2020) - "We summarize here palatability data for a new amphetamine extended-release tablet (Dyanavel XR® Extended Release Tablet; AMPH ER TAB)...2. Provide primary evidence on palatability of a new formulation of an existing product."

CNS Disorders

Pharmacokinetic Study of DYANAVEL XR (Amphetamine) Extended-release Oral Suspension, in Children Aged 4 to 5 Years (clinicaltrials.gov) - P4; N=5; Completed; Sponsor: Tris Pharma, Inc.

New P4 trial • Attention Deficit Hyperactivity Disorder • Biosimilar • CNS Disorders