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Phosphagenics Initiates Phase 1B Clinical Trial For Oxycodone

To compare matrix and reservoir system to deliver the drug

Phosphagenics has initiated Phase 1B clinical trial for its patented Oxycodone/TPM (Targeted Penetration Matrix) transdermal patch systems.

The clinical trial consists of a pharmacokinetic study in twenty healthy volunteers at the Royal Adelaide Hospital. The primary objective of the company’s Phase 1B clinical trial is to compare two transdermal patch candidates, a matrix and reservoir system, to deliver Oxycodone.

Each of the twenty subjects will be administered with an Oxycodone patch on a once daily basis for up to ten days. Oxycodone levels will be monitored to assess which of the two patch systems can deliver Oxycodone into the blood stream at therapeutic levels in a reproducible and sustained manner.

The results of the Phase 1B trial, scheduled to be completed by early 2010, will determine which of the two patch systems will be best suited for commercial development. The best candidate will be advanced into Phase II/III Oxycodone clinical trials scheduled for 2010.

Oxycodone, an opioid derivative for chronic pain management of patients suffering from debilitating diseases such as cancer. Currently the drug can be administered orally or intravenously.

Dr Esra Ogru, chief operating officer of Phosphagenics, said: “The results of our first 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 could be 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. The TPM/oxycodone patch system appears potentially suitable for chronic pain management.”