prednisolone/zoledronic acid (VOLT01) / Levolta - LARVOL DELTA

A POSSIBLE NOVEL DISEASE MODIFYING DRUG FOR OSTEOARTHRITIS (OARSI 2024) - "A novel combination of Zoledronic Acid (ZA) and Methyl Prednisolone (VOLT01) given intravenously once was evaluated in a six-month phase II study with positive results showing the combination statistically superior to ZA alone in relieving pain. This was followed up in a larger 24-month phase III study to assess efficacy."

Immunology • Musculoskeletal Diseases • Orthopedics • Osteoarthritis • Pain • Rheumatology

Levolta Pharmaceuticals Partners with Tabuk Pharmaceuticals for Commercialization of Investigational Osteoarthritis Therapy in Middle East and Africa (PRNewswire) - "Levolta Pharmaceuticals, Inc. has entered into an exclusive licensing and distribution agreement for VOLT01 with Tabuk Pharmaceutical Manufacturing Company of Riyadh, Saudi Arabia, for the commercialization of an investigational osteoarthritis (OA) therapy in the Middle East and Africa (MEA) region, excluding South Africa....Tabuk Pharmaceuticals, a fully owned subsidiary of Astra Industrial Group, will hold the marketing authorization and be responsible for registering, importing, and commercializing VOLT01 in the MEA region....Levolta expects to begin Phase III clinical trials for VOLT01 in late 2023/early 2024." "

Licensing / partnership • New P3 trial • CNS Disorders • Osteoarthritis • Pain

Zoledronic acid plus methylprednisolone versus zoledronic acid or placebo in symptomatic knee osteoarthritis: a randomized controlled trial. (PubMed, Ther Adv Musculoskelet Dis) - "The aim of this study was to compare the efficacy and safety of zoledronic acid (ZA) plus intravenous methylprednisolone (VOLT01) to ZA, and placebo for knee osteoarthritis. Administering intravenous methylprednisolone with ZA did not reduce APRs or change knee BML size over 6 months, but in contrast to ZA or placebo, it may have a beneficial effect on symptoms in knee osteoarthritis. Australian New Zealand Clinical Trials Registry: ACTRN12613000039785."

Clinical • Journal