Mydayis (amphetamine) / Takeda - LARVOL DELTA

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

Post hoc Responder and Remission Analyses from Two Studies of SHP465 Mixed Amphetamine Salts Extended-Release Among Adults with Attention-Deficit/Hyperactivity Disorder. (PubMed, J Child Adolesc Psychopharmacol) - "These post hoc analyses indicate that SHP465 MAS was associated with greater response and remission rates than PBO in adults with ADHD, with times to response and remission also nominally favoring SHP465 MAS."

Clinical • Journal • Retrospective data • Attention Deficit Hyperactivity Disorder • CNS Disorders • Psychiatry

"Japan's @TakedaPharma to acquire murder meds manufacturer @Shireplc for $62B. #Mydayis #Vyvanse #Adderall #Amphetamine FDA labeled side effects include: #Psychosis #Mania #Hallucinations #Delusions #Hostility #Aggression #Suicidal #Homicidal ideation. https://t.co/78uCKes8Le" (@PharmabuseUSA)

Adverse events • Biosimilar • CNS Disorders • Mood Disorders • Psychiatry

8 Week Multi-site Study of MYDAYIS® for Bipolar Depression (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Mayo Clinic; Initiation date: Mar 2020 ➔ Aug 2020

Clinical • Trial initiation date