Date: 2014-07-29
Type of information: Initiation of the trial
phase: 2a
Announcement: initiation of the trial
Company: Phosphagenics (Australia)
Product: TPM®/Oxycodone patch
Action
mechanism: TPM®/Oxycodone patch is an opioid transdermal patch using Phosphagenics\' delivery technology based on tocopherol phosphate.
Disease: peripheral neuropathic pain
Therapeutic area: CNS diseases
Country: Australia
Trial details:
Latest
news: * On July 29, 2014, the Australian drug delivery company Phosphagenics provided updates on its opioid transdermal patch programs after its recent announcement of a $19.2 million capital raising. This update is intended to provide clarity on how the Company will apply the newly raised funds to advance the development of its lead pharmaceutical assets. Phosphagenics is developing two novel opioid products, a TPM®/Oxymorphone patch and a TPM®/Oxycodone patch. The Company has formulated oxymorphone and oxycodone using its TPM® drug delivery platform to treat two related but distinct pain indications. The TPM®/Oxymorphone patch has been developed for systemic delivery and treatment of moderate to severe chronic pain, while the TPM®/Oxycodone patch is for localized topical delivery and treatment of peripheral neuropathic pain. The Company is advancing its TPM®/Oxycodone patch into Phase 2a development for the treatment of peripheral neuropathic pain. Previously, the Company has conducted several Phase 1 trials to optimize the transdermal technology. Now, the TPM®/Oxycodone patch is scheduled to re-enter the clinic in a Phase 2a study in Q4 2014, with ethics committee approval expected in October 2014. This single dose proof-of-concept trial will investigate the ability of the topical application of the TPM®/Oxycodone patch to provide pain relief for patients suffering from post-herpetic neuralgia (\"PHN\"), a peripheral neuropathic pain condition. The study will be conducted at a number of clinical sites in Australia. Although the Company expects to complete the trial in Q2 2015, this will depend entirely on patient recruitment rates. The Phase 2a study will help establish whether localized delivery of an opioid can relieve pain in a peripheral neuropathic pain condition. In addition to neuropathic pain, Phosphagenics also intends to investigate the application of the TPM®/Oxycodone patch to other chronic localized pain conditions such as osteoarthritis of the knee. Related to that, the Company\'s announcement in May 2014 that outlined the success of the veterinary counterpart of the TPM®/Oxycodone patch in providing pain relief to thoroughbred racehorses with shin pain provides some degree of confidence for human efficacy to non-neuropathic pain indications.The targeting of additional indications will expand the product\'s market potential. Any additional clinical studies would be conducted in the U.S. under an IND.
