Adzenys XR-ODT (amphetamine extended release orally disintegrating tablets) / Aytu BioPharma - LARVOL DELTA

"$AYTU Aytu BioPharma Announces Highest Weekly Adzenys XR-ODT(R) Prescriptions Generated Since Inception of RxConnect https://t.co/dJA4PlGiKe" (@stock_titan)

Impact of Combined Medication and Behavioral Treatment for ASD & ADHD (clinicaltrials.gov) - P2; N=18; Terminated; Sponsor: Duke University; N=48 ➔ 18; Trial completion date: Jul 2022 ➔ Apr 2021; Recruiting ➔ Terminated; Trial primary completion date: Jul 2022 ➔ Dec 2020; The study stopped recruitment of new participants due to COVID. A substudy was developed with adaptations to the main design.

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Trial termination • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • Autism Spectrum Disorder • CNS Disorders • Genetic Disorders • Psychiatry

Impact of Combined Medication and Behavioral Treatment for ASD & ADHD (clinicaltrials.gov) - P2; N=78; Not yet recruiting; Sponsor: Duke University

New P2 trial • Attention Deficit Hyperactivity Disorder • Biosimilar • CNS Disorders

Impact of Combined Medication and Behavioral Treatment for ASD & ADHD (clinicaltrials.gov) - P2; N=48; Recruiting; Sponsor: Duke University; N=78 ➔ 48; Trial completion date: Jul 2021 ➔ Jul 2022; Trial primary completion date: Jul 2021 ➔ Jul 2022

Clinical • Enrollment change • Trial completion date • Trial primary completion date

Neos Therapeutics reports third quarter 2019 financial results (GlobeNewswire) - "Neos reported growth in net product sales and net revenue per pack for its two core commercial attention deficit hyperactivity disorder (ADHD) products, Adzenys XR-ODT® and Cotempla XR-ODT®, for the three months ended September 30...Adzenys XR-ODT: $122; Cotempla XR-ODT®: $128...Total product revenues were $17.5 million for the three months ended September 30, 2019...Adzenys XR-ODT: $8.8MM; Cotempla XR-ODT: $7.2MM; Adzenys ER: $0.2MM;"

Commercial

Neos Therapeutics reports second quarter 2019 financial results (GlobeNewswire) - "In the second quarter of 2019, as reported by IQVIA, aggregate prescriptions for Adzenys XR-ODT and Cotempla XR-ODT increased by 3% compared to the second quarter of 2018. Specifically, Adzenys XR-ODT and Cotempla XR-ODT prescriptions totaled 53,588 and 37,100, respectively, in the second quarter of 2019 compared to 55,390 and 32,667, respectively, in the second quarter of 2018."

Commercial

An Open-Label, Multicenter, Single-Dose Pharmacokinetic Study of a Novel Amphetamine Extended-Release Orally Disintegrating Tablet in Preschool-Aged Children. (PubMed, J Child Adolesc Psychopharmacol) - "AMP XR-ODT 3.1 mg was well tolerated in preschool-aged children, with detectable plasma AMP concentrations over 24 hours, and a PK profile consistent with once-daily dosing."

Clinical • Journal • PK/PD data

Neos Therapeutics reports first quarter 2019 financial results (GlobeNewswire) - "Neos’ two core commercial attention deficit hyperactivity disorder (ADHD) products, Adzenys XR-ODT® and Cotempla XR-ODT®, delivered strong growth in both prescriptions and net revenue per pack for the three months ended March 31, 2019...Adzenys XR-ODT: $109; Cotempla XR-ODT®: $102...Total product revenues were $14.6 million for the three months ended March 31, 2019: Adzenys XR-ODT: $6.7MM; Cotempla XR-ODT: $5.8MM...Research and development expenses for the three months ended March 31, 2019, were $3.2 million...The increase in expense was primarily attributable to clinical trial expenses associated with the Company’s Adzenys XR-ODT post marketing commitments."

Commercial

Adzenys XR-ODT: Expiry of patents related to composition-of-matter between 2026- 2032 (Neos Therapeutics) - Annual Report 2018: Expiry of patent in US related to RDIM technology in 2026

Patent

Neos Therapeutics reports fourth quarter and year-end 2018 financial results (GlobeNewswire) - "Research and development expenses for the three months ended December 31, 2018, were $2.4 million...and for the fiscal year ended December 31, 2018, research and development expenses were $8.5 million compared to $9.0 million for the same period of 2017. The increase in the fourth quarter was primarily due to clinical trial expenses associated with post-marketing commitment studies of Adzenys XR-ODT and Cotempla XR-ODT as well as a license fee paid for NT0502."

Commercial

Neos Therapeutics reports fourth quarter and year-end 2018 financial results (GlobeNewswire) - "...Neos has granted Teva the right to manufacture and market its generic version of Cotempla XR-ODT under the Teva ANDA beginning on July 1, 2026, or earlier under certain circumstances. The company previously secured brand exclusivity for Adzenys XR-ODT until September 1, 2025 following a settlement and licensing agreement with Actavis Laboratories FL, Inc..."

ANDA • Patent