Hydrocodone bitartrate (HB) and acetaminophen (APAP) combination products are known to be abused via oral, intranasal, and intravenous self-administration. Benzhydrocodone HCl (KP201) is a prodrug of hydrocodone with limited bioavailability when taken intranasally or intravenously, or taken orally at supratherapeutic doses. This study assessed the abuse liability, relative bioavailability, and safety of KP201/APAP, compared with that of HB/APAP (Norco®), when administered at supratherapeutic oral doses to non-dependent, recreational opioid users. Both KP201/APAP and HB/APAP were generally well tolerated and had similar Drug Liking scores, but KP201/APAP displayed lower peak and cumulative systemic exposure to hydrocodone at high and mid oral doses.
Pharmacokinetic Characteristics of Intranasal Administration of Oxycodone ARIR
Abuse of prescription opioids continues to be a serious public health concern, with as many as 12.5 million individuals aged 12 or older reporting…
Data Monitoring Committee Unit
Due to increasing regulatory requirements, the need for quality study and patient safety data is critical as we work together to bring our clients’…
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