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%.