KemPharm's ADHD Candidate Meets Efficacy, Safety Trial Endpoints
KemPharm Inc (NASDAQ: KMPH) shares plunged nearly 7 percent off Monday’s open despite news that its KP415 candidate for ADHD met primary and secondary endpoints in a pivotal efficacy and safety trial.
What Happened
The drug demonstrated statistically significant improvement on the SKAMP scale for ADHD as well as the Permanent Product Measure of Performance scale, according to KemPharm.
Why It’s Important
The positive findings are significant for KemPharm considering the indication’s large and growing market opportunity. The company aims to poach market share with KP415’s broad treatment profile.
“KemPharm believes the prodrug may also demonstrate a lower abuse potential as well as less variability in the delivery of d-MPH compared to current methylphenidate products,” Monday’s press release said.
What’s Next
KemPharm intends to develop additional clinical data for KP415 through 2018, including a study of oral and intranasal Human Abuse Potential. Management expects to then submit a New Drug Application in the first quarter of 2019.
The stock rebounded 17.5 percent off the post-open low, promptly fell again and traded around $6.50 at the time of publication.
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