Date: 2014-07-29
Type of information: Initiation of development program
phase: 2a
Announcement: initiation of the development program
Company: Phosphagenics (Australia)
Product: TPM®/Oxymorphone
Action
mechanism: TPM®/Oxymorphone is an opioid transdermal patch using Phosphagenics' delivery technology based on tocopherol phosphate.
Disease: moderate to severe chronic pain
Therapeutic area: CNS diseases
Country: Australia, USA
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. Phosphagenics is now advancing its TPM®/Oxymorphone patch towards Phase 2 development in the US. Previously, the company reported positive results from two Phase 1 clinical trials, including a trial outcome in late 2013 that confirmed the transdermal delivery of therapeutic oxymorphone plasma concentrations, a very strong predictor of efficacy. Prior to Phase 2 initiation, the TPM®/Oxymorphone patch is being further characterized in two additional clinical studies. Data from both studies will support an investigational new drug (\"IND\") application that will be submitted to the FDA. The first additional clinical trial is currently in progress and addresses supplementary pharmacokinetic parameters to those examined in the previous trials. The second clinical trial, which is anticipated to start in October 2014, will evaluate two standard investigational endpoints for transdermal products; the consistency of the delivery profile among several potential patch application sites (i.e. flank, chest, upper arm and upper back) and the rest period required before a patch can be reapplied to the same application site. Both parameters are important aspects of protocol design for the Phase 2 trial that will be conducted in the USA, as well as forming part of the eventual label claims of the commercial product. The strategic change in the clinical direction for the TPM®/Oxymorphone patch from a small Australian Phase 2a study to a much larger Phase 2 trial in the U.S. was announced in the Company\'s March 2014 Newsletter to Shareholders. This change resulted from the results obtained in a multi-dose study in late 2013 and from extensive consultation with regulatory and commercial advisors following those results. This decision was also reflective of the early interest in the product from potential licensees and the need to accelerate the development of the product in the US, the primary market for the TPM®/Oxymorphone patch. Since the decision has been made to advance the clinical studies to the U.S., the Company has undertaken extensive work to ready itself for submitting an IND application to the FDA needed prior to commencement of the U.S. Phase 2 study in the first half of 2015.
