KemPharm shoots for ADHD filling in 2019
- KemPharm on Monday announced results from a pivotal trial of its attention-deficit/hyperactivity disorder drug KP415 in children ages six through 12.
- The classroom-style, 150-patient study measured efficacy using both the Swanson, Kotkin, Agler, M-Flynn, and Pelham Scale (SKAMP) and the Permanent Product Measure of Performance (PERMP) scale. SKAMP is a rating of classroom behaviors in children with ADHD and PERMP is a math test designed to asses a child's ability to initiate, self-monitor and complete the test.
- The company intends to submit a New Drug Application for the ADHD prodrug in the first quarter of 2019. Previously, KemPharm had been shooting for filing by the end of 2018.
KP415 is an extended release form of d-methylphenidate that uses the company's ligand activated therapy platform technology. Prodrugs are pharmacologically inactive drugs that become active after being metabolized in the body. KemPharm has claimed the formulation may have lower abuse potential and less variable drug delivery. Its platform strategy is based on turning already approved therapies into prodrugs.
The pivotal study was meant to test both early onset of action and extended duration of therapy. The study showed that KP415 had a statistically significant mean difference in the primary endpoint of SKAMP-combined score change from baseline from one hour to 10 hours compared with placebo.
Depending on what baseline the company used to measure scores — either pre-dose Visit Five or pre-dose Visit Six — the timing of onset of action and length of therapy duration changed. This could be why KemPharm's stock was off, trading down about 4% in morning trading after shooting higher pre-market.
The Iowa-based biotech intends to collect further clinical data over the course of 2018 ahead of a 2019 NDA submission.
Editor's Note: The headline of the article was changed to reflect that KemPharm previously announced it intends to file for approval in 2019.
Follow Lisa LaMotta on Twitter