Phosphagenics has begun a Phase IIa clinical trial of its transdermal morphine cream, TPM-01/Morphine. The trial, investigating the efficacy, absorption, and metabolism of morphine administered using Phosphagenics' novel transdermal carrier TPM-01, will be conducted at the Royal Adelaide Hospital in Australia. Preliminary results are expected during the third quarter of 2006.
In the trials, doses of morphine will be examined in 48 healthy male volunteers aged between 18 and 49 years. Volunteers will be randomly assigned into a dose group and either receive active treatment or placebo treatment in a double blinded manner. The efficacy of Phosphagenics transdermal morphine in producing the well-recognized effects of morphine in humans, such as changes in pupil size and decreased response to painful stimuli, will be measured.