Phosphagenics initiates Phase 2a clinical trial of its transdermal morphine cream
Phosphagenics Limited announced commencement of a Phase 2a clinical trial of its transdermal morphine cream, TPM-01/Morphine. The Phase 2a 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, South 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 recognised effects of morphine in humans, such as changes in pupil size and decreased response to painful stimuli, will be measured.
Phosphagenics' transdermal morphine (TPM-01/Morphine) is a non-invasive, patient friendly gel or cream that delivers morphine through the skin into the bloodstream. Previous clinical trials of TPM-01/Morphine have achieved 48 hours of therapeutic morphine blood levels from a single dose, which compares favourably to the longest acting morphine products available which provide only up to 24 hours of therapeutic blood levels per dose.
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