MELBOURNE, Australia I April 17, 2015 I Australian drug delivery company Phosphagenics Limited (ASX:POH; OTCQX:PPGNY) has commenced dosing in its Phase 2 TPM®/Oxycodone patch trial (POH 035-13).
Study POH 035-13 is a double-blind, randomised, cross-over Phase 2 clinical trial investigating the safety and efficacy of Phosphagenics’ TPM®/Oxycodone patch in up to 28 patients suffering post herpetic neuralgia (PHN). Recruitment for the trial started in February. All patients entering the formal dosing phase have satisfied a strict three stage screening process to be deemed suitable. Additional candidates are in later stages of the screening process and the flow of suitable patients is expected to accelerate. Based on recruitment estimates, the trial is expected to complete in H2 2015.
Dr Paul Gavin, Chief Scientific Officer, said: “Our objective is to develop a product that provides local pain relief for PHN sufferers and avoid the typical opioid-related systemic side effects associated with conventional opioid administration. PHN is poorly managed by the currently available treatment options and we believe patients could really benefit from a topical opioid product. At present there are no FDA-approved topical opioids for PHN. We see the TPM®/Oxycodone patch as a unique product with great potential in PHN and several other indications.”
The trial is being conducted at five sites across Australia: the Nucleus Network Facility in Melbourne, Westmead Hospital in Sydney, Royal North Shore Hospital in Sydney, St Vincent’s Hospital in Sydney and the Hunter Clinical Research facility in Newcastle.
SOURCE: Phosphagenics
Post Views: 27
MELBOURNE, Australia I April 17, 2015 I Australian drug delivery company Phosphagenics Limited (ASX:POH; OTCQX:PPGNY) has commenced dosing in its Phase 2 TPM®/Oxycodone patch trial (POH 035-13).
Study POH 035-13 is a double-blind, randomised, cross-over Phase 2 clinical trial investigating the safety and efficacy of Phosphagenics’ TPM®/Oxycodone patch in up to 28 patients suffering post herpetic neuralgia (PHN). Recruitment for the trial started in February. All patients entering the formal dosing phase have satisfied a strict three stage screening process to be deemed suitable. Additional candidates are in later stages of the screening process and the flow of suitable patients is expected to accelerate. Based on recruitment estimates, the trial is expected to complete in H2 2015.
Dr Paul Gavin, Chief Scientific Officer, said: “Our objective is to develop a product that provides local pain relief for PHN sufferers and avoid the typical opioid-related systemic side effects associated with conventional opioid administration. PHN is poorly managed by the currently available treatment options and we believe patients could really benefit from a topical opioid product. At present there are no FDA-approved topical opioids for PHN. We see the TPM®/Oxycodone patch as a unique product with great potential in PHN and several other indications.”
The trial is being conducted at five sites across Australia: the Nucleus Network Facility in Melbourne, Westmead Hospital in Sydney, Royal North Shore Hospital in Sydney, St Vincent’s Hospital in Sydney and the Hunter Clinical Research facility in Newcastle.
SOURCE: Phosphagenics
Post Views: 27
