arbaclofen placarbil (XP 19986) / Azurity Pharma, Indivior - LARVOL DELTA

Screening Targets and Therapeutic Drugs for Alzheimer's Disease Based on Deep Learning Model and Molecular Docking. (PubMed, J Alzheimers Dis) - "Drug databases and molecular docking results indicated that arbaclofen, baclofen, clozapine, arbaclofen placarbil, BML-259, BRD-K72883421, and YC-1 had high affinity for GABBR2, and FABP3 bound with oleic, palmitic, and stearic acids. This study provided a new strategy for the identification of targets and drugs for the treatment of AD using deep learning. Seven therapeutic targets and ten drugs were selected by using this method, providing new insight for AD treatment."

Journal • Alzheimer's Disease • CNS Disorders • FABP3 • GABBR2 • WDR49

A number of actionable events for XenoPort, with capital to back them up (Propthink) - Anticipated peak sales of approximately $100M by 2020 for arbaclofen placarbil; Anticipated FDA approval decision for Biogen Idec’s BG-12 March 28.

Anticipated FDA event • Anticipated sales • Multiple Sclerosis

XenoPort reports first quarter financial results (Businesswire) - Anticipated preclinical and P1 data for XP23829 by Q2/Q3 2013; Anticipated new P2/3 trial by Q4 2013; Anticipated P3 data of arbaclofen placarbil (AP) in MS in Q2 2013; Anticipated NDA submission for AP in Q4 2013.

Anticipated NDA • Anticipated new P2/3 trial • Anticipated P1 data • Anticipated P3 data • Anticipated preclinical • Multiple Sclerosis

XenoPort reports fourth quarter and year-end 2012 financial results (Businesswire) - "we are awaiting our Phase 3 AP clinical trial results in the second quarter...Assuming positive results, we would target the submission of a New Drug Application (NDA) in the United States for AP for the treatment of spasticity for patients with MS or spinal cord injury by the end of this year...about...XP23829...looking forward to receiving the results of two additional Phase 1 trials and of 13-week toxicology studies by mid-year. With these data in hand, we hope to speak to regulatory authorities about potential development paths in several indications, including...(RRMS)...”

Anticipated NDA • Anticipated P1 data • Anticipated P3 data • Multiple Sclerosis

A Dose-Escalation Study to Determine the Maximum Tolerated Dose of Arbaclofen Placarbil in Subjects With Alcohol Use Disorder (clinicaltrials.gov) - P2; N=18; Not yet recruiting; Sponsor: Reckitt Benckiser Pharmaceuticals Inc.

New P2 trial • Biosimilar

Indivior full year 2017 adjusted financial results in-line with guidance (Indivior Press Release) - "All three parts of the Phase I Bioavailability Clinical Study Protocol (INDV-AP-102) of a new formulation of Arbaclofen Placarbil are now completed. Preparation for Type C meeting with the FDA to discuss next steps for the development of Arbaclofen Placarbil for AUD-induced liver disease with cirrhosis."

FDA event • Addiction (Opioid and Alcohol)

The challenge of developing new medications: Lessons from the French experience with baclofen in alcohol use disorders (NEUROTALK 2019) - Abstract not available

Clinical