Melbourne-based Australian drug delivery company, Phosphagenics (ASX: POH; OTCQX: PPGNY), has completed a review of its TPM/Oxymorphone patch development program using specialist external consultants.
On the back of previously announced clinical trial results showing that the TPM/Oxymorphone patch can deliver blood levels of oxymorphone corresponding to the therapeutic levels seen with oral dosing, a further three critical path non-clinical studies have now been completed.
These studies assessed the “development and commercial readiness” of the patches made during the recently completed technical transfer process.
The review of these non-clinical trials has concluded that additional specialised formulation work will need to be completed before the patch can be progressed further in the clinic.
The Company will engage an external group with expertise in patch development for this process.
This reformulation is expected to delay the lodgement of an IND and Phase 2 trial planned for the USA by more than 12 months. Phosphagenics’ topical oxycodone patch is in Phase 2 clinical trials. The number of patients being dosed continues to grow each month and remains on track to complete the trial in 2H 2015.