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news.KemPharm has released positive results from a single dose, three-treatment, three-period, six-sequence, cross-over Phase 1 PK study evaluating opioid-based hydrocodone prodrug KP201 as a pain medication.
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The results of the trial confirmed that as predicted, KP201 is cleaved in man, releasing the active pharmaceutical compound hydrocodone into the bloodstream at amounts equivalent to the reference listed drug (RLD), Norco.
In the trial, 24 subjects have received oral doses of 5mg KP201, 10mg KP201, or 10/325mg tablet of hydrocodone bitartrate and acetaminophen (Norco, RLD).
The human pharmacokinetic profile of KP201 indicates that the prodrug releases hydrocodone efficiently and is bioequivalent to the comparator drug, supporting a 505(b)(2) regulatory pathway for KP201 in combination with acetaminophen.
KemPharm president and CEO Travis Mickle said they believe KP201 has the potential to assume sizeable market share, given the opportunity for extended market exclusivity in acute and chronic pain, as well as the potential to minimize opioid-induced constipation.
"We expect to be in a position to file an NDA for KP201 within the next 18 to 24 months, allowing us to position the product in full compliance with the FDA’s recent decision to limit acetaminophen in prescription products," Mickle said.