Ontinua ER (arbaclofen) / RVL Pharma - LARVOL DELTA

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=442 | Not yet recruiting | Sponsor: RVL Pharmaceuticals, Inc. | Trial completion date: Apr 2026 ➔ Apr 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple Sclerosis

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=442 | Not yet recruiting | Sponsor: RVL Pharmaceuticals, Inc. | Trial completion date: Apr 2025 ➔ Apr 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple Sclerosis

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=442 | Not yet recruiting | Sponsor: RVL Pharmaceuticals, Inc. | Trial completion date: Sep 2024 ➔ Apr 2025 | Trial primary completion date: Jun 2024 ➔ Jan 2025

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple Sclerosis

Arbaclofen extended-release tablets for spasticity in multiple sclerosis: open-label extension study. (PubMed, Brain Commun) - P3 | "Arbaclofen extended-release treatment (up to 80 mg/day) was well tolerated and reduced symptoms of spasticity in adult patients with multiple sclerosis for 1 year. Clinical Trial Identifier: ClinicalTrials.gov, NCT03319732."

Journal • Cardiovascular • CNS Disorders • Movement Disorders • Multiple Sclerosis • Myocardial Infarction • Pain

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=442 | Not yet recruiting | Sponsor: RVL Pharmaceuticals, Inc. | N=340 ➔ 442 | Trial completion date: Mar 2024 ➔ Sep 2024 | Trial primary completion date: Jan 2024 ➔ Jun 2024

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple Sclerosis

Arbaclofen extended-release tablets for spasticity in multiple sclerosis: randomized, controlled clinical trial. (PubMed, Brain Commun) - "Arbaclofen extended-release 40 mg/day for 12 weeks significantly reduced multiple sclerosis-related spasticity compared with placebo and was safe and well tolerated over the 12-week treatment period. Although arbaclofen extended-release 40 mg/day improved Clinical Global Impression of Change scores, a significant difference from placebo was not observed."

Clinical • Journal • CNS Disorders • Movement Disorders • Multiple Sclerosis

Prognostic Discrimination within a Heterogeneous Population of TP53-Aberrant Myelodysplastic Syndromes and Acute Myeloid Leukemia (ASH 2022) - "Median overall survival (OS) was similar among patients with monoallelic TP53-mutant MDS, multi-hit TP53-mutant MDS, and monoallelic TP53-mutant AML (median OS 440 days vs. 437 days vs. 440 days, respectively) (Panel A)... TP53-aberrant MDS and AML comprise a prognostically heterogeneous group of patients with inferior clinical outcomes, though the highest risk subgroup appears to be AML with multi-hit TP53 status or AML with TP53 VAF > 50%. There is high value in determining the allelic state and hit status at the time of diagnosis to help prognosticate and develop a long-term management plan. Allo-HCT improves median OS, though durable MRD-negative remission is rare."

Clinical • Heterogeneity • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • TP53

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=340 | Not yet recruiting | Sponsor: RVL Pharmaceuticals, Inc. | N=800 ➔ 340 | Trial completion date: Oct 2023 ➔ Mar 2024 | Trial primary completion date: Jul 2023 ➔ Jan 2024

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple Sclerosis

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: RVL Pharmaceuticals, Inc. | Initiation date: Apr 2022 ➔ Dec 2022

Trial initiation date • CNS Disorders • Movement Disorders • Multiple Sclerosis

OS440-3005: A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS (clinicaltrials.gov) - P3 | N=323 | Completed | Sponsor: RVL Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Movement Disorders • Multiple Sclerosis • Muscle Spasticity

A Study to Investigate Arbaclofen ER Tablets for the Treatment of Spasticity in Patients With Multiple Sclerosis (clinicaltrials.gov) - P3; N=800; Not yet recruiting; Sponsor: RVL Pharmaceuticals, Inc.

Clinical • New P3 trial • CNS Disorders • Movement Disorders • Multiple Sclerosis

[VIRTUAL] Arbaclofen Extended-Release for the Treatment of Spasticity in Multiple Sclerosis: An Open-Label Safety Study (Study OS440-3005) (CMSC 2021) - "Twice-daily arbaclofen ER treatment (up to 80 mg/day) was well tolerated for up to 1 year. Clinically meaningful improvements in TNmAS-MAL scores suggested a long-term benefit for patients with MS-related spasticity."

Clinical • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Arbaclofen Extended-Release for the Treatment of Spasticity in Multiple Sclerosis: A Randomized, Multi-Center, Placebo-Controlled Clinical Trial (Study OS440-3004) (CMSC 2021) - "Arbaclofen ER 40 mg/day for 12 weeks significantly reduced MS-related spasticity as measured by the TNmAS-MAL compared with placebo. Twice-daily arbaclofen ER (40 mg/day and 80 mg/day) also appeared to have an acceptable safety profile."

Clinical • CNS Disorders • Multiple Sclerosis

[VIRTUAL] Arbaclofen Extended-Release for Spasticity in Multiple Sclerosis: Responder Analysis of a Phase 3 Randomized, Placebo-Controlled Clinical Study OS440-3004 (CMSC 2021) - P3 | "Subjects with MS-related spasticity were more likely to respond to twice-daily oral arbaclofen ER than placebo."

Clinical • P3 data • CNS Disorders • Multiple Sclerosis

"$OSMT Osmotica Pharmaceuticals plc Receives Complete Response Letter from U.S. Food and Drug Administration for Arbaclofen Extended Release Tablets https://t.co/TFs8ohiN6v" (@stock_titan)

Clinical • FDA event

"PDUFAs remaining in F'20 $VTRS ($MYL) - MYL-1402O Dec 27th $OSMT - Ontinua ER Dec 29th" (@BioStocks)

OS440-3005: A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS (clinicaltrials.gov) - P3; N=250; Not yet recruiting; Sponsor: Osmotica Pharmaceutical US LLC; Trial completion date: Aug 2019 ➔ May 2020; Initiation date: Feb 2018 ➔ Mar 2018; Trial primary completion date: Jun 2019 ➔ Feb 2020

Trial completion date • Trial initiation date • Trial primary completion date • Biosimilar • CNS Disorders • Multiple Sclerosis

Utilization of anti spasticity drugs in multiple sclerosis: analysis from an Italian administrative database (ISPOR Eu 2013) - Presentation time: Wednesday, 6 November; Abstract #PND11; "Only 10% of patients with MS currently receive active pharmacological treatment, although this condition seems affecting more than 20% of MS patients in Europe. Also, there are not relevant alternatives or second line options to baclofen, which is the most commonly prescribed drug in this condition."

Retrospective data • Multiple Sclerosis

Osmotica announces FDA acceptance of filing for Ontinua ER for alleviation of spasticity resulting from multiple sclerosis and strong advancement in the clinical program for Osmolex ER (Businesswire) - "Osmotica Pharmaceutical...announced today that the New Drug Application (NDA) for OntinuaTM ER has been accepted for filing by the U.S. Food and Drug Administration (FDA)."

NDA • Multiple Sclerosis

OS440-3004: A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS (clinicaltrials.gov) - P3; N=536; Completed; Sponsor: Osmotica Pharmaceutical US LLC; Active, not recruiting ➔ Completed

Clinical • Trial completion

OS440-3005: A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MS (clinicaltrials.gov) - P3; N=323; Active, not recruiting; Sponsor: Osmotica Pharmaceutical US LLC; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

OS440-3004: A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS (clinicaltrials.gov) - P3; N=536; Active, not recruiting; Sponsor: Osmotica Pharmaceutical US LLC; Recruiting ➔ Active, not recruiting; Trial completion date: Apr 2019 ➔ Jan 2019

Clinical • Enrollment closed • Trial completion date