Phosphagenics completes IND-enabling pain patch study

Phosphagenics (ASX:POH) has completed the first of two planned studies to support an Investigational New Drug application in the US for pain patch TPM/oxymorphone.

The single-dose pharmacokinetic study was conducted at Linear Clinical Research’s facility in Perth. It involved 15 healthy volunteers and was designed to address pharmacokinetic parameters not addressed in the previous multidose phase I trial.

Results from the study matched those from the phase I trial - all 15 subjects reached an oxymorphone blood concentration well above the minimum therapeutic blood level.

Phosphagenics Chief Scientific Officer Dr Paul Gavin added that the results also provide information regarding the elimination phase of oxymorphone after patch removal.

“As with any transdermal system, drug delivery ceased upon patch removal and residual drug in the body was eliminated steadily over time,” he said.

“This represents one of the key safety advantages of a transdermal opioid system compared to the oral dosage form ... accidental overdose rarely occurs because of the ease of intervention - [all that is required is] removal of the unintended patches.”

Data from the trial will be used to help design an upcoming phase II trial, which is expected to commence in 1H15 following the submission of an IND application.

Prior to this, a second IND-enabling study is expected to commence in October, Phosphagenics announced last month. It will evaluate the consistency of the delivery profile and the rest period before a patch can be reapplied to the same area of skin.

Phosphagenics is also at the phase II trial stage for a second opioid-based patch, TPM/oxycodone.

Phosphagenics (ASX:POH) shares were trading 2% higher at $0.102 as of around 1.30 pm on Monday.