Transdermal Morphone Gel Shows Positive Phase IB Clinical Trials

Filed in archive Drugs, Vaccines and Therapeutics on January 20, 2006

TPM-01/Morphine is a non-invasive, patient-friendly gel that delivers morphine through the skin into the bloodstream. Its developers, Australia-based Phosphagenics announced the completion and positive results from an 18-patient single dose, open label, randomised study that examined its pharmacokinetics.

In the study, the morphine gel, administered via a single application to the upper arm, achieved therapeutic blood morphine levels within 2 hours and these were maintained for over 48 hours with full clearance occurring by 72 hours.

Phosphagenics claims that topical administration may have several advantages over oral administration, in that side effects commonly associated with oral administration of morphine such as constipation, nausea, and drowsiness are eliminated. Additionally, transdermal delivery could offer sustained delivery of morphine for chronic pain sufferers.

Phosphagenics now plans to seek approval for a Phase IIa trials to assess the product's efficacy in relief of post-operative pain. The trials are expected to commence in early 2006.

Source: Phosphagenics