Phosphagenics has initiated Phase 1B clinical trial for its patented Oxycodone/TPM (Targeted Penetration Matrix) transdermal patch systems. The primary objective of the Phase 1B clinical trial is to compare systemic levels of Oxycodone for the two transdermal patch candidates, the matrix and reservoir systems.
Reportedly, each of the 20 subjects and will be administered with an Oxycodone patch on a once daily basis for up to ten days. Systemic Oxycodone levels will be monitored to assess which of the two patch systems can deliver sustained therapeutic levels of Oxycodone into the blood stream.
The results of the Phase 1B trial are scheduled to be completed by early 2010 and are expected to determine the best candidate for commercial development. The Phase II/III Oxycodone clinical trials are scheduled for 2010.
The company said that in an Australian clinical trial conducted earlier this year on 50 subjects, Phosphagenics has demonstrated that its formulation did not cause sensitisation or irritation, the major barriers preventing the use of most opioids in topical delivery systems.
In addition to Oxycodone, it is highly likely that the TPM patch system may have application to the majority of opioids, giving clinicians several alternatives in the treatment of chronic pain.
Esra Ogru, chief operating officer at Phosphagenics, said: “The results of our first clinical trial earlier this year were a world first and were suggestive of the potential for the TPM system to change the way in which chronic pain is treated in the future.
“Currently, patients treated with oral oxycodone obtain pain relief for only a short period of time. The earlier human trial conducted by Phosphagenics, indicates that our Oxycodone patch may provide sustained drug delivery for a matter of days. This trial will help determine just how long we can provide patients with sustained pain relief.”