Acura Pharma : Hydrocodone Bitartrate With Acetaminophen Tablets Meet Endpoints

(RTTNews) - Acura Pharmaceuticals Inc.(ACUR) announced preliminary results from three clinical studies for its abuse deterrent AVERSION hydrocodone bitartrate with acetaminophen or AVERSION H/A development product with the key study demonstrating that AVERSION H/A met the objective of conformance with the Food and Drug Administration's or FDA standards for bioequivalence when compared to the reference drug NORCO, when taken in the fasted state.

The company noted that a food effect was observed with the AVERSION H/A formulation with lower peak blood concentrations for both hydrocodone and acetaminophen than the comparator product.

In addition, the studies demonstrated dose proportionality, or relatively consistent blood exposure, across all three dosage strengths of AVERSION H/A.

Finally, Acura evaluated blood levels of hydrocodone compared to VICOPROFEN and of acetaminophen compared to ULTRACET, for additional safety. AVERSION H/A blood levels of hydrocodone were consistent with the comparator product while acetaminophen peak blood levels were higher than those observed for the comparator product.

According to the company, AVERSION H/A was generally well tolerated in all the clinical studies with no serious adverse events observed. AVERSION H/A exhibited consistent exposure levels of hydrocodone and acetaminophen across all three studies. Acura continues to review the results from these studies.

The three Acura studies, Study AP-ADF-302, AP-ADF-303 and AP-ADF-304, conclude Acura's planned clinical studies to demonstrate the pain relief efficacy and safety of AVERSION H/A.

Acura believes the level of food effect observed and the increased peak exposure to acetaminophen are not clinically relevant, but all these results will be subject to FDA review and concurrence.

Acura has previously indicated the need to provide additional clinical data on the snorting abuse deterrent features of AVERSION H/A which is pending the successful completion of a dispute resolution proceeding Acura initiated with the FDA regarding FDA's determination that snorting is not a relevant route of abuse for hydrocodone combination products.