KemPharm Receives FDA Clearance to Initiate KP879 Clinical Program for the Treatment of Stimulant Use Disorder
January 27, 2021 at 08:30 am EST
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KemPharm, Inc. announced that the U.S. Food and Drug Administration (FDA) has completed its review of the Investigational New Drug (IND) application for KP879 (KP879 IND), concluding that the Company may proceed with its planned clinical investigation of the product candidate. KemPharm expects to initiate the clinical program for KP879 in 2021. In addition, the Company reported that it has completed its multi-phase process to regain its Nasdaq listing and to restructure its balance sheet. KP879 is being developed as an extended-duration, agonist replacement therapy for the treatment of Stimulant Use Disorder (SUD), a condition for which there are no FDA-approved medications. KP879 utilizes serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate. SDX is also the primary active pharmaceutical ingredient (API) of KP415 and KP484, the Company’s product candidates which are intended for the treatment of attention-deficit/hyperactivity disorder (ADHD). It is anticipated that certain data from previously completed research may be leveraged for KP879, which KemPharm believes could potentially streamline the development timeline of KP879. Per the definitive collaboration and license agreement with an affiliate of Gurnet Point Capital (GPC) dated September 3, 2019, GPC holds an option to negotiate the terms of a new license agreement with KemPharm for the rights to develop and commercialize KP879 once the Company has established clinical proof-of-concept.
Zevra Therapeutics, Inc. is a rare disease company science, data, and patients need to create transformational therapies for diseases with limited or no treatment options. The Company has a diverse portfolio of products and product candidates, which includes a combination of both a clinical stage pipeline and commercial stage assets. Its pipeline includes arimoclomol, an orally delivered, investigational product candidate being developed for Niemann-Pick disease type C (NPC). KP1077 is the Company's lead clinical development product candidate which is being developed as a treatment for idiopathic hypersomnia (IH), a rare neurological sleep disorder, and narcolepsy. Its commercial product, AZSTARYS, a once-daily treatment for attention deficit hyperactivity disorder (ADHD), in patients aged six years and older containing its prodrug, serdexmethylphenidate (SDX), and d-methylphenidate (d-MPH). Its other commercial product is OLPRUVA.
ZEVRA THERAPEUTICS, INC. 
