KemPharm Announces Serdexmethylphenidate (SDX) Has Been Classified as a Schedule IV Controlled Substance by the DEA - Seite 2

“The decision by the DEA further builds our confidence in how parents, healthcare providers and payors will view AZSTARYS as an option to consider for patients living with ADHD,” said Perry Sternberg, President and CEO of Corium, Inc., which will commercialize AZSTARYS in the U.S. “We believe the knowledge that SDX, which comprises 70% of the API in AZSTARYS, has been classified as a Schedule IV controlled substance, will be meaningful when considering the potential benefit of SDX’s lower abuse potential. We are enthusiastically continuing our commercial launch preparations to bring AZSTARYS to the U.S. market as early as the second half of 2021.”

“The DEA’s decision may also positively impact the value proposition for KemPharm’s lead pipeline product candidate, KP879, and potentially other SDX-based products,” Dr. Mickle continued. “KP879, which is intended for the treatment of stimulant use disorder, is based on SDX as the sole API. If approved, KP879 could be a Schedule IV product, and physicians who are treating patients seeking to overcome addictions to cocaine, methamphetamine or other stimulants may be able to prescribe KP879 with the knowledge that the product candidate could have a significantly lower potential for abuse. For a therapeutic area that currently has no approved treatments available, this determination could be a game changer.”

Per the License Agreement, as amended, with an affiliate of Gurnet Point Capital (GPC), KemPharm has earned a $10 million milestone payment which is payable within 30 days following the scheduling determination of SDX by the DEA.

About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here: https://kempharm.com/wp-content/uploads/2021/03/AZSTARYS-Master-Label- ...

About KemPharm:

KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LAT (Ligand Activated Therapy) technology. KemPharm utilizes its proprietary LAT technology to generate improved prodrug versions of FDA-approved drugs as well as to generate prodrug versions of existing compounds that may have applications for new disease indications. KemPharm’s prodrug product candidate pipeline is focused on the high need areas of attention deficit hyperactivity disorder, or ADHD, stimulant use disorder (SUD) and CNS rare diseases, including idiopathic hypersomnia (IH). KemPharm’s lead clinical development candidate for the treatment of SUD, KP879, is based on its prodrug of d-methylphenidate, known as serdexmethylphenidate (SDX). In addition, KemPharm has received FDA approval for AZSTARYS, a new once-daily treatment for ADHD in patents age six years and older, and for APADAZ, an immediate-release combination product containing benzhydrocodone, a prodrug of hydrocodone, and acetaminophen. For more information on KemPharm and its pipeline of prodrug product candidates visit www.kempharm.com or connect with us on Twitter, LinkedIn, Facebook and YouTube.