Supernus Pharmaceuticals, Inc. engages in the development and commercialization of products for the treatment of central nervous system diseases. It offers Trokendi XR, Oxtellar XR, APOKYN, XADAGO, and MYOBLOC products. The company was founded by Jack A. Khattar on March 30, 2005, and is headquartered in Rockville, MD.
Supernus Pharmaceuticals received Paragraph IV Notice Letters from third parties who submitted Abbreviated New Drug Applications (ANDAs) for generic versions of Qelbree (viloxazine extended-release capsules) in 100, 150, and 200 mg strengths.
Supernus Pharmaceuticals' SPN-820, an mTORC activator for treatment-resistant depression, failed to demonstrate statistical significance against placebo in Phase IIb study, showing only a marginal 0.4-point difference in MADRS scores.
Sanofi has reached an agreement with CD&R to sell a 50% stake in its consumer health business Opella, with France's Bpifrance taking an additional 2% stake, deal expected to close in Q2.
The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience.
The FDA has approved ONAPGO (apomorphine hydrochloride) as the first subcutaneous apomorphine infusion device for treating motor fluctuations in advanced Parkinson's disease.
Supernus Pharmaceuticals' SPN-820, a novel mTORC1 modulator, demonstrated safety and efficacy as an adjunctive treatment for major depressive disorder in a Phase IIa trial.
Supernus Pharmaceuticals' SPN-820 demonstrated rapid and substantial improvement in major depressive disorder (MDD) symptoms within two hours in a Phase IIa trial.
The FDA issued a Complete Response Letter (CRL) for Supernus Pharmaceuticals' New Drug Application (NDA) for SPN-830 (apomorphine) for Parkinson's disease.