Ferrer announces best-in-class results in phase I for Lorediplon in insomnia
Ferrer announced that it has completed phase I clinical trials of Lorediplon in insomnia. The trials demonstrated the orally available compound has a best-in-class efficacy profile in terms of sleep maintenance and sleep quality when compared to market leader zolpidem.
The pharmacodynamic effects of a single oral administration of Lorediplon (at 1mg, 5mg and 10mg doses), zolpidem (10mg) and placebo, were assessed in 34 healthy adult subjects employing a phase advanced model of insomnia, in which subjects retire to bed five hours earlier than normal and are required to stay there until early morning. In this model Lorediplon demonstrated dose related clinical benefits in measured sleep parameters that were either comparable to or exceeded zolpidem, in terms of the duration and quality of sleep that subjects achieved. Lorediplon was safe and well tolerated, with no residual effects observed up to 14 hours after dosing.
In addition, Lorediplon has proven safe and well tolerated in the 129 subjects involved in all Phase I clinical studies.
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