Posidorm®
Melatonin, a natural hormone, secreted by the pineal gland, it 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 the elderly and in children with neurodisabilities. 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 optimal profile has been confirmed in the Phase I trials. Further indications are envisaged post–launch: jetlag and sleeping disorders in the blind.
Melatonin therapy is the obvious first line approach to many sleeping disorders. Proof of principle 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 current hypnotic therapy.
Posidorm is in phase III trials in the UK.
Prior to the approval and launch of Posidorm, Posidorm can be made available on a named patient basis subject to regulatory approval for those patients with an unmet clinical need. IDIS, the global leader in the supply of unlicensed medicines will be managing the named patient supply of Posidorm on behalf of Alliance.
For information on the supply of Posidorm please contact IDIS:
IDIS International Sales
Tel: +44 (0) 1932 824 123
E-mail: internationalsales@idispharma.com
UK & Republic of Ireland
Tel: +44 (0) 1932 824 100
Email: uk@idispharma.com
Isprelor®
Misoprostol is currently licensed in the UK for the treatment of peptic ulcers but has also been widely used off label in obstetrics including cervical ripening and induction of labour
Alliance has completed Phase III trials of misoprostol 25mcg for use in the induction of labour.
Isprelor® (misoprostol 25mcg) may become an integral part of obstetric care for women. 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 with a proper pharmaceutical formulation.
It is expected that a European Marketing Authorisation for Isprelor will be applied for in 2009.
