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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"}]
Find Clinical Drug Pipeline Developments & Deals by Supernus Pharmaceuticals
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.
Acquistion will strengthens Parkinson’s disease portfolio with GOCOVRI (amantadine) extended release capsules, the first and only FDA-approved medicine indicated for the treatment of both OFF and dyskinesia in patients with Parkinson’s disease receiving levodopa-based therapy.
The transaction will provide Supernus with two marketed products: GOCOVRI (amantadine) extended release capsules, indicated for both OFF and dyskinesia in patients with Parkinson’s disease and Osmolex ER (amantadine) tablets, approved for Parkinson’s disease.
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