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.
Data Demonstrate that KP415 Can Be Administered without Regard to Food; Can Be Mixed into Foods or Drink
Celebration, FL – October 22, 2019 – KemPharm, Inc. (Nasdaq: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, announced that study results demonstrating the ability of KP415 to be administered without regard to food and via alternative dosing methods was presented at the 66th Annual American Academy of Child and Adolescent Psychiatry (AACAP) Meeting in Chicago. KP415 is KemPharm’s prodrug product candidate of d-methylphenidate (d-MPH) being developed for the treatment of attention deficit hyperactivity disorder (ADHD). On September 3, 2019, KemPharm entered into a license and collaboration agreement with an affiliate of Gurnet Point Capital (“GPC”) for the commercial rights to KP415 and related development products.
The poster, which was presented at AACAP on October 19th and is titled, “Effect of Food and Alternative Dosing Methods on the Pharmacokinetics of KP415, an Investigational ADHD Product Containing the Prodrug, Serdexmethylphenidate (SDX),” reported data from a Phase 1 study of KP415 designed to address the potential effects of food and alternative dosing methods (capsule contents sprinkled on applesauce, stirred in water) on the pharmacokinetics (PK) of single doses of KP415 capsules. Results from the study indicated that, in general, food did not impede drug absorption or the production of d-MPH, suggesting that KP415 may be administered to patients with or without food either as a whole capsule, sprinkled on applesauce or stirred in water.
“In designing KP415, we sought to address key unmet needs with currently marketed methylphenidate-based ADHD treatments, including earlier onset of therapy, longer duration of therapy and consistency of therapeutic effect, as well as the possibility of lower abuse potential,” said Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm. “In addition to these important properties, physicians and caregivers have also indicated that ADHD treatments that can be administered without regard to food, in a small capsule size and/or with the ability to mix into food or drink are advantageous, particularly when treating pediatric patients. The data presented at AACAP confirm that KP415 remains clinically similar whether administered on a full or empty stomach or when the already relatively small capsule is opened and sprinkled on food or into a drink. We look forward to including this data as part of the New Drug Application (NDA) for KP415 which, together with GPC, we are currently working to finalize.”
The study presented at AACAP was sponsored by KemPharm.
KemPharm is a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs to treat serious medical conditions through its proprietary LATTM (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 our 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 potential timing and outcome of the NDA submission for KP415, and the potential benefits of KP415, 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, 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.