The development of Posidorm, the company’s melatonin product for insomnia, is now expected to be completed in the fourth quarter of 2009 instead of in the fourth quarter of 2007.
The original plan for Posidorm’s development was based on discussions with the UK Medicines and Healthcare products Regulatory Agency, which took into account medical and scientific literature on melatonin. That plan envisaged UK registration first, followed by registration in other European countries. The pan-European registration routes that now have to be followed take less account of the accumulated knowledge about melatonin.
Preliminary results from the phase III trials of Posidorm in shift workers and elderly patients indicate a significant improvement in sleep duration compared with placebo.
“While the additional guidance on Posidorm from the EMEA involves further time and cost, it does give a clear pathway through the registration process and allows an optimized pan-European product launch,” said John Dawson, Alliance Pharma’s chief executive.