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FDA","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Supernus Pharmaceuticals","sponsor":"Navitor Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Dr. Vince Clinical Research Announces First Dosing in a Phase II Study in Patients With Depression","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase II"},{"orgOrder":0,"company":"Supernus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Supernus Provides Regulatory Update for SPN-830","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Supernus Pharmaceuticals","sponsor":"Moksha8 Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"M8 Pharmaceuticals, an Acino company, Signs an Exclusive Licensing Agreement with Supernus for Qelbree\u00ae (Viloxazine XR) in Latin America","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Approved"},{"orgOrder":0,"company":"Supernus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Find Clinical Drug Pipeline Developments & Deals by Supernus Pharmaceuticals
SPN-817 (Huperzine A) is a novel, first-in-class highly selective acetylcholinesterase (AChE) inhibitor for epilepsy. It is being evaluated in in adult patients with treatment-resistant seizures.
The agreement aims to seek regulatory approval and commercialize Qelbree, which is approved in the United States is an extended-release formulation of viloxazine, a selective norepinephrine reuptake inhibitor to treat ADHD in adults and children 6 years of age and older.
SPN-830 (apomorphine) is a novel and less invasive therapy, which acts as dopamine D2 receptor agonist, and is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
SPN-820 is a novel small molecule activator of the mechanistic target of rapamycin complex 1 (mTORC1) currently under phase 2 development for use in major depressive disorder.
SPN-830 (apomorphine) is a novel and less invasive therapy, which is acts as dopamine D2 receptor agonist, which is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
SPN-830 (apomorphine) is a novel and less invasive therapy, which is acts as dopamine D2 receptor agonist, which is investigated for the treatment of motor fluctuations (OFF episodes) in Parkinson’s disease.
SPN-830 is an investigational apomorphine infusion device under review for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s disease (PD).
At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qelbree versus placebo.
U.S.FDA notice for company’s NDA, resubmission for SPN-830 for treatment of motor fluctuations in Parkinson’s disease is considered a standard review thereby assigning a timeline of 10 months for review by FDA and establishing a PDUFA target action date in early October 2022.
Company announced resubmission of NDA for SPN-830 (Apomorphine Hydrochloride) for the continuous treatment of motor fluctuations in Parkinson’s Disease.
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