naltrexone low dose (JAN123) / JanOne - LARVOL DELTA

JanOne Earns US Patent for the Use of its Novel Formulation of Low-Dose Naltrexone, Jan123, to Treat Chronic Pain (PRNewswire) - "JanOne...has earned a US patent for its innovative formulation of low-dose naltrexone, Jan123, for treating pain....In citing features of the drug's formulation, the new patent explains Jan123's mechanism of action, including that 'it increases endogenous enkephalins and endorphins which are the body's natural pain killers,' resulting in a decrease in patient pain."

Patent • Pain

JanOne files international patent application for methods of using low dose naltrexone to treat chronic pain (PRNewswire) - "JanOne Inc...has just filed an international patent application for methods of using low dose naltrexone to treat chronic pain....JanOne is developing Jan123 (a novel formulation of low dose naltrexone) to treat CRPS, an orphan disease with no current FDA-approved treatments."

Patent • CNS Disorders • Pain

JanOne Completes Pre-IND Meeting with FDA on Jan123 (PRNewswire) - "JanOne...has completed a successful pre-IND meeting with the FDA regarding Jan123. Jan123 is the company's unique oral delivery of low dose naltrexone formulated to treat complex regional pain syndrome, an orphan disease of severe, debilitating impact. The Pre-IND meeting with the FDA produced a path toward formal drug application. Discussion topics included preclinical toxicology, CMC (Chemistry, Manufacturing and Control), pharmacokinetics, and clinical implementation. The agency's feedback will be used to move Jan123 toward a New Drug Application under a 505-b2 designation."

FDA event • CNS Disorders • Pain

JanOne to Present Data On Its Two Non-Opioid Drug Candidates at The Appalachian Region Spine and Pain Meeting on Drug Development Programs to Treat Pain on April 15, 2023 (PRNewswire) - "JanOne...Dr. Amol Soin, Chief Medical Officer of JanOne, will be presenting at the Appalachian Region Spine and Pain Meeting in Sulfur Springs, West Virginia on Saturday, April 15th on the topic of Innovation in Pain Medicine and will be discussing the drug development programs at JanOne. JanOne is a biotech company that is developing two different late-stage non-opioid drug candidates: JAN 101 is designed to treat peripheral artery disease that was also shown to improve pain in patients with diabetic neuropathy in a phase II study and JAN 123 which is low dose naltrexone to treat Complex Regional Pain Syndrome."

Clinical data • Preclinical • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne to Present Important Trial Results at Annual Meeting of American Society of Interventional Pain Physicians (PRNewswire) - “JanOne…will present data on two of its investigational pharmaceutical compounds at the American Society of Interventional Pain Physicians (ASIPP) annual meeting in Washington DC in March, 2023. Dr. Amol Soin, Chief Medical Officer of JanOne, will present results from the Phase IIa trial of JAN 101, which treats patients with painful diabetic peripheral neuropathy. He will also report data from in vitro studies of JAN 123, the low-dose naltrexone that treats complex regional pain syndrome and is being readied for late-stage clinical trials to facilitate FDA approval.”

P2a data • Preclinical • CNS Disorders • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

JanOne Inc. Completes Acquisition of Soin Therapeutics, LLC (PRNewswire) - “JanOne Inc…announced today that it has completed the acquisition of Soin Therapeutics, LLC and its product, a patent-pending, novel formulation of low-dose naltrexone. This all stock transaction has a value of $13M, with up to an additional $17M depending on revenues generated by the product, for a total value of up to $30M….The product, now named Jan123, is being developed for the treatment of Complex Regional Pain Syndrome (CRPS)…There are no truly effective treatments for CRPS, which, together with the relatively small number of patients afflicted with the disease, resulted in the FDA granting Orphan Drug Designation. This designation will provide JanOne with tax credits for its clinical trials, exemption of user fees, and the potential of seven years of market exclusivity following approval.”

Commercial • Licensing / partnership • CNS Disorders • Pain