The Company, in concert with a Contract Research Organization ("CRO"), has completed a pivotal bioequivalence study for Acurox™ Tablets (Study AP-ADF-104) using tablets from batches manufactured by the Company at its Culver Facility at a scale of sufficient size to fulfill the FDA’s requirements for a 505(b)(2) NDA submission.  Study AP-ADF-104 was a pivotal, single‑dose, open‑label, randomized, two‑period crossover bioequivalence study conducted under fasting conditions to compare the pharmacokinetic characteristics of Acurox™ Tablets (oxycodone HCl, 5mg)  to the FDA reference listed drug, Roxicodone® tablets,15 mg.  Subjects received two separate drug administrations in assigned periods, one treatment per period, according to a randomization schedule.  Dosing days were separated by a washout period of at least 7 days.  An equal number of subjects were randomly assigned to each possible sequence of treatments.  Drug administration consisted of an oral dose of 3 x Acurox™ Tablets or 1 x Roxicodone® tablet, 15 mg.  Thirty‑nine (39) of forty (40) healthy adult subjects completed the study.  The results demonstrated that Acurox™ Tablets are bioequivalent to Roxicodone® tablets.  The 90% confidence intervals for peak exposure based on ln(C_max) and overall systemic exposure based on ln(AUC_last) and ln(AUC_inf) of oxycodone were well within the FDA’s acceptable range for bioequivalence.  The Company intends to include the data and results of Study AP-ADF-104 in its 505(b)(2) NDA submission to the FDA for Acurox™ Tablets.