Mydayis (amphetamine) / Takeda - LARVOL DELTA

Drugs for ADHD. (PubMed, Med Lett Drugs Ther) - No abstract available

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

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (clinicaltrials.gov) - P2 | N=74 | Completed | Sponsor: Mayo Clinic | Active, not recruiting ➔ Completed

Trial completion • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (clinicaltrials.gov) - P2 | N=90 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Aug 2025 | Trial primary completion date: Dec 2025 ➔ Jun 2025

Enrollment closed • Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Lithium-Induced Nephrotic Syndrome: A Rare Complication of a Known Kidney Offender (KIDNEY WEEK 2024) - "She has been taking Lurasidone, Clonazepam, Desvenlafaxine and Mydayis. She was started on Lithium Carbonate 4 months prior...However, if the symptoms persist beyond 6 weeks, a kidney biopsy to exclude other causes and treatment with prednisone have been done in the case reports. Kidney biopsy usually shows minimal change disease.This case provides an example of a rare renal side effect of Lithium that occurs after relative short duration of treatment.."

Bipolar Disorder • CNS Disorders • Depression • Glomerulonephritis • Hepatology • Human Immunodeficiency Virus • Immunology • Infectious Disease • Inflammation • Metabolic Disorders • Nephrology • Psychiatry • Renal Disease • Rheumatoid Arthritis • Suicidal Ideation

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

"Had to switch to pricey Mydayis due to no Adderall IR to be found and ins no longer covering XR. SMH at the idiocacy." (@rileydogtoo)

"@TakedaPharma my @cvs pharmacist says you’re no longer producing mydayis. True?" (@rickindc)

"#Australia desperately needs more options for #ADHD treatment. @TakedaPharma please bring #mydayis to the Australian market" (@Tr50700851)

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

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

"@TakedaPharma Please bring Mydayis to the Australian market!! We only have 3 options for ADHD medication here." (@Tr50700851)

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

In brief: Alternatives to Adderall. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening (clinicaltrials.gov) - P3 | N=52 | Completed | Sponsor: NYU Langone Health | Recruiting ➔ Completed | N=34 ➔ 52

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

"hi @TakedaPharma have you considered an IR version of mydayis… there is proven high demand!!" (@192001e)

"Shout out to the wonderful @TakedaPharma for making my Narcolepsy medication - MyDayIs - affordable and accessible. Seriously, you guys are the best." (@katiegnelson)

Narcolepsy • Sleep Disorder

Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening (clinicaltrials.gov) - P3; N=34; Recruiting; Sponsor: NYU Langone Health; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Dec 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

Pharmacokinetics, Safety, and Tolerability of SHP465 Mixed Amphetamine Salts After Administration of Multiple Daily Doses in Children Aged 4-5 Years with Attention-Deficit/Hyperactivity Disorder. (PubMed, CNS Drugs) - P1 | "In children aged 4-5 years with ADHD, following multiple once-daily administrations of SHP465 MAS 6.25 mg, the pharmacokinetic profile of plasma d-amphetamine and l-amphetamine was generally consistent among participants. Between-individual variability of plasma d-amphetamine and l-amphetamine steady-state exposure was low to moderate. SHP465 MAS was generally well tolerated in this study."

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

Safety of SPD465 in Treating Adults With ADHD. (clinicaltrials.gov) - P3; N=505; Completed; Sponsor: Shire; N=1040 ➔ 505

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

Study of the Duration and Efficacy of MYDAYIS on Adult ADHD Symptoms and Executive Function Throughout the Day Into the Early Evening (clinicaltrials.gov) - P3; N=34; Recruiting; Sponsor: NYU Langone Health; Not yet recruiting ➔ Recruiting; Trial completion date: Jun 2021 ➔ Dec 2021; Trial primary completion date: Jun 2021 ➔ Dec 2021

Clinical • Enrollment open • Trial completion date • Trial primary completion date • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

A Long-Term, Open-Label, Safety Study of Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD. (PubMed, J Atten Disord) - "Triple-bead MAS exhibited a long-term safety profile comparable with previous reports and demonstrated evidence of continued symptom control for up to 12 months."

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

Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD: Results of a Phase 3, Double-Blind, Randomized, Forced-Dose Trial. (PubMed, J Atten Disord) - "Triple-bead MAS significantly reduced adult ADHD symptoms; the safety profile was consistent with previous triple-bead MAS studies."

Clinical • Journal • P3 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Insomnia • Psychiatry • Sleep Disorder • Xerostomia

A Phase 3, Randomized Double-Blind Study of the Efficacy and Safety of Low-Dose SHP465 Mixed Amphetamine Salts Extended-Release in Children with Attention-Deficit/Hyperactivity Disorder. (PubMed, J Child Adolesc Psychopharmacol) - P3 | "SHP465 MAS 6.25 mg once daily (one-half the lowest dose approved for adolescents and adults) was well tolerated in children aged 6-12 years but was not superior to placebo in reducing ADHD symptoms, suggesting that this dose of SHP465 MAS was subtherapeutic in this age group. The Clinical Trial Registration number: NCT03325881."

Clinical • Journal • P3 data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mental Retardation • Pain • Psychiatry

Improved Executive Function in Adults Diagnosed With Attention-Deficit/ Hyperactivity Disorder as Measured by the Brown Attention-Deficit Disorder Scale Following Treatment With SHP465 Mixed Amphetamine Salts Extended-Release: Post Hoc Analyses From 2 Randomized, Placebo-Controlled Studies. (PubMed, J Atten Disord) - "Response rates (SHP465 MAS vs. placebo) favored SHP465 MAS (all nominal p < .0001) in the dose-optimization (BADDS <50: 41.9% vs. 19.2%; below 90% CI range: 57.4% vs. 29.6%) and fixed-dose (BADDS <50: 51.9% vs. 16.7%; below 90% CI range: 70.6% vs. 32.3%) studies. Improvement in EF measured by BADDS response rates was approximately 2-fold greater with SHP465 MAS than placebo."

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

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Mayo Clinic; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Bipolar Disorder • CNS Disorders • Depression • Mood Disorders • Psychiatry

Post-Hoc Analyses of the Effects of Baseline Sleep Quality on SHP465 Mixed Amphetamine Salts Extended-Release Treatment Response in Adults with Attention-Deficit/Hyperactivity Disorder. (PubMed, CNS Drugs) - P3 | "Improvements in ADHD symptoms and executive function occurred with dose-optimized SHP465 MAS, regardless of baseline impairment in some aspects of sleep in adults with ADHD, with no significant differences observed as a function of sleep impairment."

Clinical • Journal • Retrospective data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Mental Retardation • Psychiatry • Sleep Disorder

[VIRTUAL] Pharmacokinetics, Safety, and Tolerability of SHP465 Mixed Amphetamine Salts After Multiple Daily Doses in Children Aged 4-5 Years With ADHD (AACAP 2020) - No abstract available

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