[{"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 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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":"Allos Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Allos Pharma Inc. Presents New Positive Data Analyses at the 18th NFXF International Fragile X Conference","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 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 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":"Allos Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Allos Pharma Inc. Receives FDA Guidance for the Design of a Phase 3 Trial to Support a New Drug Application for Treatment of Fragile X Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Nexus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Nexus Pharmaceuticals Launches Baclofen Injection, USP","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"ANI Pharmaceuticals Inc","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ANI Pharmaceuticals Announces the Launch of Baclofen Oral Suspension","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for NCGC00024579-05
ANI will commercialize a generic version of the reference-listed drug Fleqsuvy (baclofen). It is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain.
Baclofen is a gamma-aminobutyric acid (GABA-ergic) agonist. It is indicated for treatment of patients with multiple sclerosis, cerebral palsy, spinal cord injuries, and other conditions that result in muscle spasms.
Arbaclofen selectively activates GABA-B receptors to decrease presynaptic release of excitatory neurotransmitters while simultaneously decreasing excitability of the postsynaptic neuron.
The financing by Neovacs will support Pharnext operations and cash requirements, in particular the Phase III PREMIER pivotal study assessing its PTX3003 (baclofen) candidate in CMT1A, a rare debilitating peripheral neuropathy with currently no existing approved therapy.
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.
Clinically meaningful magnitudes of improvement were observed on all three ABCFX subscales for 45% of individuals receiving high dose of arbaclofen vs 4% treated with placebo (P=0.00003), clearly demonstrating efficacy of STX209 (arbaclofen) in individuals with Fragile X.
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.
Amneal is adding Saol’s experienced institutional commercial team for Lioresal that can be utilized to support product launches, including biosimilar products, filgrastim (biosimilar for Neupogen), pegfilgrastim (biosimilar for Neulasta) & bevacizumab (biosimilar for Avastin).
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