Iowa, USA-based specialty drugmaker KemPharm (Nasdaq: KMPH) says a key pivotal trial of its lead candidate, an investigational attention-deficit/hyperactivity disorder (ADHD) product, met the primary and secondary efficacy endpoint.
The trial is evaluating KP415, which contains a compound called d-methylphenidate and one of its prodrugs, in patients aged 6-12. Topline results show a statistically-significant improvement according to several commonly used measures of ADHD symptoms.
Chief executive Travis Mickle said: “We anticipate developing additional clinical data for KP415 throughout 2018, including the completion of our ongoing oral and intranasal Human Abuse Potential studies.”
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