11 August 2014
PHOSPHAGENICS COMPLETES FIRST IND ENABLING STUDY FOR TPM®/OXYMORPHONE PATCH
Phosphagenic announces that the first of its additional studies designed to further characterise the TPM®/Oxymorphone patch, in support of an Investigational New Drug (IND) application with the FDA, has been completed. The study was conducted on 15 healthy volunteers at Linear Clinical Research’s facility in Perth. It assessed additional pharmacokinetic parameters associated with the safety and elimination profile that were not addressed in the previous multiple dose Phase 1 study. The data generated will be used to help design the upcoming Phase 2 study, support the IND application and inform the eventual product label.
- Single dose pharmacokinetic (PK) study reproduces earlier results
- Therapeutic oxymorphone blood levels achieved in all 15 subjects
- Drug elimination indicates favourable safety profile
28 July 2014
PHOSPHAGENICS OPIOID PATCH PROGRAM UPDATE
Phosphagenic provides the following update on its opioid transdermal patch programs after its recent announcement of a $19.3 million capital raising. This update is intended to provide clarity on how the Company will apply the newly raised funds to progress the development of its lead pharmaceutical assets.
- Next phase of the TPM®/Oxymorphone clinical development program has commenced
- TPM®/Oxycodone Phase 2a trial to be conducted in Australia during Q4/2014
- Upcoming opioid pain patch trials fully funded