Posters include intranasal and oral HAP data for serdexmethylphenidate (SDX), as well as PK data for KP415
Intranasal HAP data selected to be presented during oral “data blitz session”
CELEBRATION, Fla., Jan. 18, 2019 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that research assessing the oral and intranasal human abuse potential (HAP) of serdexmethylphenidate (SDX), KemPharm’s prodrug of d-methylphenidate (d-MPH), as well as new pharmacokinetic (PK) data for KP415, will be presented in four posters and one oral “data blitz session” at the 2019 Annual Meeting of the American Professional Society for ADHD and Related Disorders (APSARD) being held in Washington, D.C., starting today, January 18th, through January 20th.
SDX is the major active pharmaceutical ingredient in KP415 and KP484, KemPharm’s co-lead clinical development product candidates intended for the treatment of attention-deficit/hyperactivity disorder (ADHD), as well as KP879, a newly identified product candidate being developed for the treatment of Stimulant Use Disorder (SUD).
“The findings being presented at APSARD are significant,” said Travis Mickle, Ph.D., KemPharm’s President and Chief Executive Officer. “The HAP studies indicate the possibility that SDX may have lower abuse potential than d-MPH comparators when administered orally or intranasally. Moreover, the PK studies demonstrated that KP415 capsules (containing SDX and immediate-release d-MPH) produced predictable d-MPH exposure across doses and age groups, and demonstrated the potential to provide a rapid onset and extended-duration benefit. Combined, the HAP and PK data showcase the potential benefits that KP415 could provide as a treatment for ADHD.”
The first poster, titled, “Single-dose pharmacokinetics of KP415, an investigational product containing the prodrug serdexmethylphenidate (SDX) in children and adolescents with ADHD,” was a single-dose, single-period study of orally administered KP415 capsules in children 6-12 years of age and adolescents 13-17 years of age. Consistent with prior studies of methylphenidate products, the study found that systemic dose-normalized exposure to d-MPH following oral administration of KP415 was higher in younger children, which appears to be related to lower d-MPH clearance in subjects with lower body weights. This poster is being presented today, Friday, January 18th.
The second poster, also being presented today, titled, “Dose-proportionality and steady-state pharmacokinetics of KP415, an investigational ADHD product containing serdexmethylphenidate (SDX), a novel prodrug of d-methylphenidate,” was a Phase 1, open-label, randomized, single-dose, 3-treatment, 3-period crossover study evaluating the PK’s of three clinical doses of KP415 in healthy adults. KP415 produced dose-proportional increases in the rate and extent of d-MPH exposure across a relatively wide range of doses, and steady-state plasma concentrations were achieved prior to the third dose.
The third poster, being presented Saturday, January 19th, titled, “Human Abuse Potential of Intranasal Serdexmethylphenidate (SDX), a novel prodrug of d-Methylphenidate, in Recreational Stimulant Abusers,” is also featured as one of eight posters selected to participate in an oral “data blitz session.” This was a Phase 1, randomized crossover, double-blind, single-dose, active- and placebo-controlled study that compared the HAP and PK’s of intranasally administered (IN) SDX and IN d-MPH HCl in recreational stimulant users with a history of intranasal stimulant use. IN SDX produced lower exposure to d-MPH relative to IN d-MPH HCl, and correspondingly, produced pharmacodynamic effects that were significantly lower than IN d-MPH HCI on multiple abuse-related endpoints, including the primary endpoint of maximal (Emax) Drug Liking.
Finally, the fourth poster, also being presented on Saturday, January 19th, is titled “Human Abuse Potential of Oral Serdexmethylphenidate (SDX), a Novel Prodrug of d-Methylphenidate, Compared to Focalin®XR and Phentermine in Recreational Stimulant Abusers.” This was a Phase 1, randomized crossover, double-blind, single-dose, active- and placebo-controlled study of orally administered SDX in recreational stimulant users. The study found that SDX produced a gradual onset of abuse-related effects and maximal effects which were statistically lower than Focalin XR (Schedule II stimulant) on all abuse-related endpoints and statistically lower than phentermine (Schedule IV stimulant) on a majority of abuse-related endpoints.
KemPharm funded the studies which were conducted at various external clinical facilities.
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 product pipeline is focused on the high need areas of ADHD, pain and other central nervous system disorders. 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.
The American Professional Society for ADHD and Related Disorders (APSARD) is an organization consisting of a broad spectrum of allied mental health experts working to improve the quality of care for patients with ADHD through the advancement and dissemination of research, and evidence-based practices. APSARD will fill unmet education and training needs for healthcare professionals helping patients with ADHD, from childhood through adulthood.
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, 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 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, 2017, KemPharm’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2018, 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.