Probudur is Virpax's post-operative, ultra-long-acting anesthetic injection product candidate for post-operative pain management that is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications.
Probudur's proprietary formulation is intended for immediate onset and has demonstrated sustained pain control for up to 96 hours in animal studies.
The company entered into a cooperative research and development agreement (CRADA) in May of 2022 with the US Army Institute of Surgical Research, the primary laboratory of the Department of Defense, to evaluate Probudur for trauma and critical care challenges.
Dr. Neil Singla is board certified in Anesthesiology and the Founder and chief scientific officer of Lotus Clinical Research, a leading analgesic clinical research organization with extensive analgesic and pain-related expertise.
He has interacted frequently with the FDA's Analgesics Division and is a nationally recognized key opinion leader in analgesic protocol design and implementation. Dr. Singla has published extensively and is a frequent lecturer for physicians, pharmaceutical companies, and medical research institutes throughout the country.
He currently chairs the Analgesic Clinical Trials Shared/Special Interest Group at the International Association for the Study of Pain(IASP), chaired the Clinical Trials Shared Interest Group at the American Pain Society through 2019 and chairs the annual Conference on Analgesic Clinical Trials.
Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery.
Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms.
Probudur is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer.
Virpax is also using its intranasal Molecular Envelope Technology to develop two other product candidates.
PES200 is a product candidate being developed to manage post-traumatic stress disorder and NobrXiol is a product candidate being developed for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of rare pediatric epilepsy.
Virpax acquired global rights to NobrXiol.
Virpax is also seeking approval of two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis.
GC Biopharma's GC1130A receives EMA Orphan Drug Designation
Guangzhou Fermion Technology's FZ008-145 IND application receives Chinese regulatory approval
Newron enrols 290 patients in schizophrenia study
Vistagen granted European patent for AV-101 to treat neuropathic pain
Alora Pharmaceuticals announces Relexxii commercial launch
IGC Pharma granted patent for Alzheimer's drug formulation
NRx Pharmaceuticals signs data agreement with Columbia University for IV Ketamine trials
Cambridge Cognition launches AQUA for automated quality assurance in CNS clinical trials
Shanghai Zhimeng Biopharma's CB03 receives US FDA orphan drug designation
Genentech's Alecensa demonstrates 76% reduction in disease recurrence risk
NRx Pharmaceuticals announces presentation at 8th Annual Dawson James Conference