KemPharm, Inc. today announced that it has commenced a Phase 1 clinical trial in healthy volunteers with KP201, its novel abuse deterrent prodrug of hydrocodone for pain. KP201 is a new chemical entity (NCE) and is the most advanced opioid-based lead candidate in KemPharm's emerging pipeline. KemPharm's technology provides a way to impart improved properties to new drug candidates through chemical modification of existing FDA-approved drugs. KP201 now joins KemPharm's clinical pipeline, which includes the more advanced Phase 2 candidate KP106, a prodrug for the treatment of attention-deficit hyperactivity disorder (ADHD).
"Preclinical studies suggest that KP201 may have reduced abuse potential and lower incidence of constipation when compared with currently approved narcotic treatments for pain," commented Sven Guenther, Ph.D., Vice President of Research for KemPharm. "The exciting aspect of KP201 is that the abuse deterrent attributes are inherent to the molecule itself. As a result, KP201 is on a path to possibly become the first marketed opioid analgesic with innate abuse deterrent properties without requiring complex formulations."
"The rapid development of KP201 using minimal resources while concurrently advancing our extensive pipeline is a testament to the creativity and hard work of the KemPharm team," commented Travis Mickle, Ph.D., President and Chief Executive Officer of KemPharm.
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