Acura Pharmaceuticals Hydrocodone Bitartrate With Acetaminophen Tablets Meet Clinical Endpoints - Seite 2

Study AP-ADF-302 is an open label, single dose, randomized, crossover study in 36 healthy adult subjects measuring blood concentration of hydrocodone and acetaminophen in fed and fasted states. In the fasted state, a single AVERSION H/A 10/325mg tablet was found to meet FDA's standards for bioequivalence compared to an equivalent dose of NORCO. A finding of bioequivalence compared to an FDA approved drug is typically sufficient to establish the safety and efficacy of a test formulation. AVERSION H/A 10/325mg was also tested in the fed state following a standardized meal, which demonstrated a 13.7% and 34.4% average reduction in peak blood concentration for hydrocodone and acetaminophen, respectively, compared to NORCO in the fasted state. These food effect results are consistent with the AVERSION technology and also the known effect of food on acetaminophen in general and the reduction is not expected to have a meaningful clinical impact.

Study AP-ADF-303 is an open label, single dose, randomized, crossover study in 24 healthy adult subjects measuring blood concentration of hydrocodone and acetaminophen in the fasted state across three different dose levels of AVERSION H/A. The blood exposure of hydrocodone and acetaminophen were proportionately the same across all three doses of AVERSION H/A successfully demonstrating dose consistency of the formulation.

Study AP-ADF-304 is an open label, single dose, randomized, crossover study in 24 healthy adult subjects measuring blood concentration of hydrocodone and acetaminophen in the fasted state to determine pharmacokinetics and safety of AVERSION H/A 7.5/325mg compared to equivalent doses of VICOPROFEN (for hydrocodone) and ULTRACET (for acetaminophen), for additional safety. Extent of exposure, measured by Area Under the Curve or AUC, is comparable for both hydrocodone and acetaminophen between AVERSION H/A and the respective comparator products. The peak exposure, measured by maximum plasma concentration or Cmax, is consistent for hydrocodone but AVERSION H/A was approximately 23% higher than the comparator based on the geometric mean. A large variability in acetaminophen results is observed in the study and is being further evaluated.