We employ our Ligand Activated Therapy (LAT) platform technology to create new molecular entity (NME) prodrugs in order to improve one or more of the attributes of approved drugs, such as susceptibility to abuse, bioavailability and safety. We create NME prodrugs by chemically attaching one or more molecules, or ligands, to an FDA-approved parent drug. When combined with the parent drug, our ligands create prodrugs designed to have improved drug attributes while maintaining efficacy equivalent to the parent drug. Once administered, targeted human metabolic processes, such as those in the GI tract, separate the ligand from the prodrug and release the parent drug, which can then exert its therapeutic effect.
KemPharm has employed its LAT prodrug platform to create a diverse pipeline of prodrug therapeutics that target large market opportunities in pain, attention deficit hyperactivity disorder (ADHD) and other central nervous system indications. KemPharm’s most advanced clinical development candidates are KP511/ER, an extended release (ER) formulation of KP511, KemPharm’s NME prodrug of hydromorphone, KP415, a NME prodrug of methylphenidate, which KemPharm is developing for the treatment of ADHD, and KP201/IR, an acetaminophen (APAP)-free formulation of its immediate release (IR) hydrocodone product, KP201.
In June 2016, Apadaz™, KemPharm’s prodrug of hydrocodone formulated in combination with acetaminophen (APAP), received a Complete Response Letter (CRL) from the FDA and is currently under active regulatory review. Apadaz has been developed as an immediate release (IR) product candidate for the treatment of acute moderate to moderately severe pain.
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