KemPharm has reported positive results from a Phase I clinical trial of its opioid-based drug candidate, KP201.
The single dose, three-treatment, three-period, six-sequence and cross-over Phase I study included 24 healthy volunteers and showed the drug candidate reduced pain and improved pharmacokinetic profile.
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The study also evaluated the serum concentrations of hydrocodone and intact KP201, as well as its safety and tolerability.
KemPharm Research vice-president Sven Guenther said: “The pharmacokinetic profile of KP201 indicates that the prodrug releases hydrocodone…and can deliver additional patient benefits, including reduced potential for abuse as well as reduction or elimination of opioid-induced constipation.”
