KemPharm designed KP201/APAP to deter tampering and abuse by selecting a molecular structure that prevents the release of the opioid upon crushing, physical manipulation and the application of other commonly employed extraction techniques. This approach to abuse-deterrence at the molecular level contrasts with other abuse-deterrent technologies, which are formulation-based, combining the opioid drug with another drug or in an abuse-deterrent capsule or physical matrix.
We believe our molecular-based approach to abuse-deterrence may be more effective than many formulation-based approaches as we believe the KP201 prodrug does not release hydrocodone effectively upon intranasal administration and has very poor solubility in blood, water and other solvents, thus rendering it unsuitable for IV administration.
KP511/ER also utilizes KemPharm’s LAT platform technology to create its abuse-deterrent properties at the molecular level, which we believe may enable abuse-deterrent characteristics similar to KP201/APAP.
Additionally, based on the molecular structure of KP511, KemPharm believes it may be possible that the metabolic processes of releasing hydromorphone from the prodrug become saturated at excessively large oral doses. If confirmed by further studies, this could potentially mean that KP511 and KP511/ER may reduce the risk of oral overdosing by a unique mechanism that is inherent in the prodrug molecule itself.
