Conducted on 15 healthy volunteers at Linear Clinical Research’s facility in Perth, Australia, the study validated additional pharmacokinetic parameters associated with the safety and elimination profile that remained unaddressed in the previous multiple dose Phase I study.
During the single dose study, all 15 subjects achieved an oxymorphone blood concentration that was well above the minimum therapeutic blood level for the drug.
The data generated is expected to be used to help design the upcoming Phase II study, support the IND application and also inform the eventual product label.
Phosphagenics chief scientific officer Dr Paul Gavin said: "The TPM ® /Oxymorphone patch has demonstrated reproducibility in two independent manufacturing and clinical trial campaigns with all subjects tested demonstrating blood concentrations equivalent to those produced by the commercially available oral dosage form.
"The latest study also provides new information regarding the elimination phase of oxymorphone after patch removal, an important variable in patient safety that is needed to determine the Phase II study design.
"As with any transdermal system, drug delivery ceased upon patch removal and residual drug in the body was eliminated steadily over time."
The company is scheduled to start the second planned characterisation study, which will compare the transdermal absorption of oxymorphone from application of the patch to different parts of the body, and inform the selection of appropriate sites for application of patches during Phase II.
Phosphagenics intends to commence the Phase II trial in the US during the first half of 2015 following the submission of an IND with the FDA.