• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

KemPharm launches pivotal efficacy trial for extended-release ADHD prodrug

January 8, 2018 By Sarah Faulkner

KemPharmKemPharm (NSDQ:KMPH) has launched a pivotal efficacy trial of its extended-release prodrug product for the treatment of attention deficit hyperactivity disorder in children.

The company’s classroom-style study is designed to support a potential label for KP415 that would include both early-onset and long duration treatment effect for ADHD.

The 140-patient trial is slated to wrap up by the end of the second quarter of 2018.

“The start of the KP415 pivotal efficacy trial is a significant milestone in our effort to provide the first product with a methylphenidate prodrug to ADHD patients,” president & CEO Travis Mickle said in prepared remarks. “The trial is designed to collect evidence for a potential claim in the KP415 label indicating early onset and extended treatment effect, both of which are unmet by current methylphenidate products.”

The company’s chief executive added that they hope to submit an NDA for KP415 to the FDA during the first quarter of next year.

KemPharm has come a long way from just one year ago, Mickle told Drug Delivery Business News. 

“At the time, we had two clinical candidates and they were both fairly early-stage – phase I types. Now we have six, in just a year’s time, plus a hefty back-log of things that I don’t talk about on a regular basis, with ADHD now being our major focus,” he said. “That’s been a huge transformation for us and has allowed us to move the pipeline ahead very rapidly.”

The 32-person company is focused on creating prodrugs – compounds that are chemically modified to boost an aspect of their pharmacokinetics. KemPharm scientists chemically attach ligands, an inert group like a sugar or a protein, to the parent drug. The ligand is later removed by the body, leaving the parent drug to deliver its desired effect.

Another big news item from 2017 for KemPharm was the progress made with its pain product, Apadaz. In 2016, the FDA ruled that the opioid pain drug could not be labeled as abuse-deterrent, concluding that it didn’t have the evidence to support the claim. The company has since responded with an appeal and an amended NDA submission, which the FDA is slated to review by February.

“We feel that we’re in a very good position with the agency,” Mickle said. “We know what they’re looking for, as far as the label goes. There was never a concern about the safety or efficacy of the product, so that’s in our benefit.”

The company has other pain products in its pipeline, but Mickle said they are keeping those products in the background for now.

“We want to apply our resources very, very strategically. Apadaz has a green light and a path for commercialization, which will more than likely be through a partner,” he explained. “Either through a strategic partner like a pharma or a generic company, or a non-traditional partner like a pharmacey benefit manager.”

KMPH shares were trading at $4.94 apiece in early-morning activity today, up +1.9%.

Want to stay on top of DDBN content? Sign up for our e-mail newsletter for a weekly dose of drug-device news.

Filed Under: Clinical Trials, Featured, Neurological, Pharmaceuticals, Research & Development, Wall Street Beat Tagged With: kempharm

IN CASE YOU MISSED IT

  • Breaking: Sequel to launch twiist automated insulin delivery system next month
  • Dexcom shares U.S. report on CGM benefits for type 2 diabetes
  • Study backs Tandem automated insulin delivery in pregnant women with type 1 diabetes
  • Data backs Medtronic MiniMed 780G for type 2, children as company seeks expanded indications
  • Abbott could pave new roads in diabetes management with dual sensor on the horizon

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS