[{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharnext Receives Promising Innovative Medicine Designation for PXT3003 ","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharnext Provides Regulatory and Clinical Update on PXT3003 Phase III Study for the Treatment of Charcot-Marie-Tooth Type 1A","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Immune Therapeutics","pharmaFlowCategory":"D","amount":"$402.0 million","upfrontCash":"$2.0 million","newsHeadline":"Statera Biopharma and Immune Therapeutics Inc. Announce Strategic Agreement for Rights to Low Dose Naltrexone","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Halberd Corporation","sponsor":"Hamden Group","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Halberd Signs Development and Marketing Agreement for Medications & Nutraceuticals","therapeuticArea":"Neurology","highestDevelopmentStatus":"Undisclosed","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Undisclosed"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Data from First Phase III Clinical Study of PXT3003 in Charcot-Marie-Tooth Disease Type 1A, the PLEO-CMT Trial, Published in the Orphanet Journal of Rare Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Currax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Currax Pharmaceuticals Granted Type C Meeting with FDA Regarding its Phase 3 Study to Evaluate the Safety and Efficacy of CX-101","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences Achieves Successful Completion of Part A of MultipleAscending Dose (MAD)\/Bioequivalents (BE) Trial for its Next Generation Opioid, PF614","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Statera Biopharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Statera Biopharma Submits Phase 1 Clinical Trial Protocol to FDA for Investigational Treatment of Long-Haul COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex, a Sorrento Company, Highlights Safety Data From Phase 1 Trial of SP-104, a Proprietary Low Dose Naltrexone for Fibromyalgia","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase I"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data from the Open-Label PLEO-CMT-FU Trial Shows Sustained Benefit with PXT3003 in Patients with Charcot-Marie-Tooth Disease Type 1A After 5 Years of Total Trial Time","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Amneal Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Amneal Launches LYVISPAH\u00ae (baclofen) for Spasticity Related to Multiple Sclerosis and Other Spinal Cord Disorders","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Approved"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharnext Announces First Patient Enrolled in Open Label Extension of the Pivotal Phase III Study of PXT3003 for the Treatment of Charcot-Marie-Tooth Disease Type 1A, the PREMIER Trial","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Pharnext","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pharnext: Findings From 'Real-World' Digital Lifestyle Study, CMT&Me, on Symptom Burden of Charcot-Marie-Tooth Disease Type 1A Published in the Journal of Clinical Neuromuscular Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Currax","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Contrave\u00ae\/Mysimba\u00ae Demonstrates No Increased Risk in Major Adverse Cardiac Events in A Large, Long-Term Real-World Evidence Study","therapeuticArea":"Nutrition and Weight Loss","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Nutrition and Weight Loss","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Vivitrol
Contrave, also marketed as Mysimba is an extended release fixed dose combination of naltrexone HCL/bupropion HCL indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults.
Under this agreement, Hamden will have worldwide exclusive rights to sell, market and distribute the HALB patented low-dose Naltrexone medication, and the HALB proprietary Vita-Shield-Max TM Nutraceutical Product.
PXT3003 (baclofen) completed an international Phase III trial with positive topline results for the treatment of CharcotMarie-Tooth disease type 1A (‘CMT1A’) and benefits from orphan drug status in Europe and the United States.
PXT3003 (baclofen) is a novel fixed-dose synergistic combination of baclofen, naltrexone and sorbitol formulated as an oral solution given twice a day for the treatment of Charcot-Marie-Tooth disease type 1A.
LYVISPAH is bioequivalent to oral baclofen tablets and provides flexible, a skeletal muscle relaxant, is well established for the treatment of spasticity and spinal cord injuries.
New data from the ongoing Open-Label Phase III Extension Study of PXT3003 (baclofen), the PLEO-CMT-FU trial, suggest good safety profile and continuous treatment effect of PXT3003 measured on the Overall Neuropathy Limitation Scale after 5 years of total trial time.
Phase 1 clinical trial data showed that SP-104 (naltrexone hydrochloride) treated healthy volunteers and had lower rates of adverse events, as compared with immediate release naltrexone -treated volunteers.
Statera will receive milestones, new indications and royalties, Crohn’s disease and COVID-19 indications and regulatory approvals, payments from Immune Therapeutics in exchange for Statera’s rights to any product containing low-dose naltrexone as an active ingredient.
STAT-205 may show promise in treating both acute COVID infections and long COVID in this manner. Preliminary in vitro data demonstrated the drug’s ability to slow or halt the progression of SARS-CoV-2 (the virus that causes COVID-19) in human lung cells.
The Part A of the trial evaluated three dose levels of PF614 showed positive review from the Phase 1b tria, independent Safety Review Committee allowed the trial to proceed to the next dose level.
Market Place
Upload your Marketing & Sales content on your company Virtual Booth, click HERE
