KemPharm is a clinical stage, specialty pharmaceutical company engaged in the development and discovery of proprietary prodrugs that are designed to be improved versions of widely prescribed and FDA approved products.
Celebration, FL – October 22, 2020 – KemPharm, Inc. (OTCQB: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that research involving KP415 and serdexmethylphenidate (SDX) will be featured in two oral presentations during the Annual American Academy of Child and Adolescent Psychiatry (AACAP) 2020 Virtual Meeting. In addition, research conducted by KemPharm’s scientific team related to patterns of abuse of prescription stimulant products, will be presented during the poster session. The two oral presentations will be delivered on October 23, 2020 as part of the “Research Pipeline: New Findings on Diagnostic and Therapeutics” session (2:00 p.m. to 4:00 p.m., ET).
KP415 is KemPharm’s investigational product candidate for the treatment of attention deficit hyperactivity disorder (ADHD). Serdexmethylphenidate (SDX) is KemPharm’s prodrug of d-methylphenidate (d-MPH). KP415 consists of SDX co-formulated with immediate-release d-MPH. A New Drug Application (NDA) for KP415 is currently under review with the U.S. Food and Drug Administration (FDA) with an anticipated PDUFA date of March 2, 2021.
“We are pleased that three studies involving KP415, the potentially advantageous properties of SDX, and the patterns of abuse of prescription stimulant products were accepted for scientific presentations at the AACAP 2020 Virtual Meeting,” said Travis Mickle, Ph.D., President and CEO of KemPharm. “Having two oral presentations and a poster session during this important scientific gathering demonstrates the amount of scientific interest in the potential for KP415 to address unmet needs for treating patients with ADHD. As the regulatory review of KP415 advances towards an expected March 2, 2021 PDUFA, we believe the research presented at AACAP 2020 provides additional information that will prove beneficial to potential future prescribers, including data affirming the lower abuse potential of SDX and the importance of minimizing such abuse.”
The first oral presentation, “Human Abuse Potential Assessment of Serdexmethylphenidate (SDX), A Novel Prodrug of d-Methylphenidate,” examines the human abuse potential of SDX in comparison to standard d-methylphenidate (d-MPH) products when administered by routes commonly reported by stimulant abusers (oral, intranasal and intravenous). To be presented by Lynn Webster, M.D., Vice President of Scientific Affairs at PRA Healthsciences, data from this comprehensive series of studies suggest that SDX may have a lower intrinsic abuse potential than d-MPH HCl when administered via the most common routes of abuse for methylphenidate (MPH) products.
The second oral presentation, “Analysis of Growth Velocity in Children Treated for up to 12 Months with KP415, an Investigational ADHD Product Containing the Prodrug Serdexmethylphenidate (SDX),” provides an analysis of the potential effects of KP415 on expected gains in weight and height in children treated for up to 12 months. To be presented by Ann Childress, M.D., President of the Center for Psychiatry and Behavioral Medicine, the research examined the body weight and height of children who participated in a Phase 3, long-term, open label safety study of KP415, concluding that, consistent with prior studies of MPH products, long-term treatment with KP415 can lead to modest reductions in expected weight and lower-than-expected increases in height based on individual subject age and sex. However, such deficits relative to children in the general U.S. population diminish or plateau later in treatment.
In addition, a poster presentation titled, “Patterns of Abuse of Prescription Stimulant Products from the National Addictions Vigilance Intervention Program (NAVIPPRO®): 2010-2018,” will highlight a study designed to characterize patterns of abuse of prescription stimulants, including MPH products, abuse among adolescents and adults being evaluated for substance abuse treatment. Submitted by Andrew Barrett, Ph.D., KemPharm’s Vice President, Scientific Affairs, data from the study suggests that abuse of prescription MPH products by multiple routes of administration remains prevalent in adolescents and adults and is associated with risky abuse-related behaviors such as injection drug use.
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, and stimulant use disorder. KemPharm’s co-lead clinical development candidates for the treatment of ADHD, KP415 and KP484, are both based on a prodrug of d-methylphenidate, but have differing duration/effect profiles. In addition, KemPharm has received FDA approval 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.
Caution Concerning Forward Looking Statements:
This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company’s proposed development and commercial timelines, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing and probability of potential FDA approval of the KP415 NDA, and the potential commercial launch of KP415. The potential clinical benefits of KP415 or any of KemPharm’s product candidates are based on information currently available to KemPharm and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Risks concerning KemPharm’s business are described in detail in KemPharm’s Annual Report on Form 10-K for the year ended December 31, 2019, and KemPharm’s other Periodic and Current Reports filed with the Securities and Exchange Commission. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.