Posidorm®
Melatonin, a natural hormone, secreted by the pineal gland, is the regulator of normal sleep and its deficiency or imbalance is potentially a cause of many sleeping disorders.
Posidorm®(melatonin 1.5mg) is being developed by Alliance initially for sleeping disorders in adults. Posidorm’s surge sustained formulation provides 0.5mg of melatonin as an immediate release to promote sleep and 1.0mg as sustained release over several hours to maintain sleep. This profile has been confirmed in Phase I trials. Posidorm® has completed proof of principle studies. Further indications are envisaged post–launch including jetlag and sleeping disorders in the blind, shift workers and children with neurodisabilities.
Melatonin therapy is the obvious first line approach to many sleeping disorders and its utility has been established by a large and ever–growing bibliography. Melatonin’s pharmacology and mode of action means it may not have the limitations of many current hypnotic therapies.
Isprelor®
Misoprostol is currently licensed in the UK for the treatment and prevention of peptic ulcers but has also been widely used off label in obstetrics including for cervical ripening and induction of labour.
Alliance Isprelor® (misoprostol 25mcg) for use in the induction of labour.
In the UK, approximately 20% of births require labour induction (145,000 per annum)
The most common methods of labour induction are the use of prostaglandins, prostaglandin analogues and oxytocin – the choice of induction agent is dependant upon the cervix state. The Royal College of Obstetricians and Gynaecologists has called for robust randomised controlled trials of misoprostol in this indication with a proper pharmaceutical formulation.
Two phase three clinical trials of Isprelor® have been completed. Their results have been presented at the 20th European Congress of Obstetrics and Gynaecology held in Lisbon in March 2008,
and the 7th International Scientific meeting of the Royal College of Obstetrics and Gynaecologists held in Montreal in September 2008,
and published in the British Journal of Obstetrics and Gynaecology (BJOG-2008 Sep; 115(10):1279-88).
Once clinical development is completed application for European Marketing Authorisation is planned.
