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Patient in the Double-Blind Segment of Phase 2b ALS Trial: Topline Clinical Efficacy Results Expected December 2023","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company Announces Market Research Results with Neurologists, Headache Specialists, and Primary Care Physicians Demonstrating Potential High Unmet Needs In Treating Acute Migraine Targeted By ELYXYB\u00ae with Potential Advantages Compared to Cal","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase IV","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase IV"},{"orgOrder":0,"company":"NeuroSense Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"},{"orgOrder":0,"company":"Scilex Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Scilex Holding Company Announces Filing of a New Drug Submission (NDS) to Health Canada\u2019s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the Approval of ELYXYB\u00ae for Acute Treatment of Migraine With or Without","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Virios Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virios Therapeutics, Inc. Reaches Alignment with FDA on Requirements for Advancing Development Candidate IMC-2 as Treatment for Long-COVID","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Virios Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Virios Therapeutics Announces Plans to Advance Development of IMC-2 as Treatment for Symptoms Associated with Long-COVID","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"NeuroSense Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"NeuroSense Reports Additional Positive Results from its ALS Phase 2b PARADIGM Trial","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Small molecule","productStatus":"Approved","date":"February 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase II"}]

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            Development Status

            Details:

            BDSI intends to launch ELYXYB in the first quarter of 2022. Additionally, BDSI plans to conduct an ELYXYB pediatric study, which will have the potential to address the significant unmet needs of pediatric and adolescent patients suffering from migraine attacks.

            Lead Product(s): Celecoxib

            Therapeutic Area: Neurology Product Name: Elyxyb

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: BioDelivery Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition September 09, 2021

            Details:

            ELYXYB is an oral solution of celecoxib, formulated using a self-micro emulsifying drug delivery system that improves solubility and bioavailability of the drug leading to better absorption.

            Lead Product(s): Celecoxib

            Therapeutic Area: Neurology Product Name: Elyxyb

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: BioDelivery Sciences

            Deal Size: $15.0 million Upfront Cash: $6.0 million

            Deal Type: Acquisition August 04, 2021

            Details:

            Ethypharm has acquired the exclusive rights for the development, registration and commercialization in the top 5 European markets of a novel celecoxib formulation already approved in the US for the acute treatment of migraine. Celecoxib is developed by Dr Reddy's.

            Lead Product(s): Celecoxib

            Therapeutic Area: Neurology Product Name: Elyxyb

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Ethypharm

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition May 19, 2021

            Details:

            Lonza will develop, optimize, and qualify a method utilizing Neuron-Derived Exosomes, set to be integrated into the development program of PrimeC, a novel extended-release oral formulation of a unique fixed-dose combination of ciprofloxacin and celecoxib, by NeuroSense.

            Lead Product(s): Ciprofloxacin,Celecoxib

            Therapeutic Area: Neurology Product Name: PrimeC

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Lonza Group

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration April 09, 2024

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            Details:

            PrimeC is a novel extended-release oral formulation composed of a unique FDC of ciprofloxacin and celecoxib. It is under phase 2 clinical development for the treatment of amyotrophic lateral sclerosis (ALS).

            Lead Product(s): Ciprofloxacin,Celecoxib

            Therapeutic Area: Neurology Product Name: PrimeC

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 21, 2024

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            Details:

            IMC-2 (combination of valacyclovir and celecoxib) is being evaluated in phase 2 clinical trials as a potential treatment for managing the fatigue, sleep, attention, pain, autonomic function and anxiety associated with Long COVID.

            Lead Product(s): Valacyclovir,Celecoxib

            Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 22, 2024

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            Details:

            IMC-2 (combination of valacyclovir + celecoxib) is being evaluated in phase 2 clinical trials as a treatment for the fatigue, orthostatic intolerance and other symptoms associated with LC illness, also known as post-acute sequelae of SARS-CoV-2 infection (PASC) or Long Covid.

            Lead Product(s): Valacyclovir,Celecoxib

            Therapeutic Area: Infections and Infectious Diseases Product Name: IMC-2

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 02, 2024

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            Details:

            Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug that acts as a cyclooxygenase-2 inhibitor. It is indicated for the acute treatment of migraine with or without aura in adults.

            Lead Product(s): Celecoxib

            Therapeutic Area: Neurology Product Name: Elyxyb

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 26, 2023

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            Details:

            PrimeC is a novel extended-release oral formulation composed of a unique FDC of ciprofloxacin and celecoxib. It is under phase 2 clinical development for the treatment of amyotrophic lateral sclerosis (ALS).

            Lead Product(s): Ciprofloxacin,Celecoxib

            Therapeutic Area: Neurology Product Name: PrimeC

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 14, 2023

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            Details:

            Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. Celecoxib inhibits prostaglandin synthesis, primarily via inhibition of COX-2. It is being developed for migrane pain.

            Lead Product(s): Celecoxib

            Therapeutic Area: Neurology Product Name: Elyxyb

            Highest Development Status: Phase IV Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 22, 2023

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