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Ergomed meets primary endpoint in clinical study of insomnia drug Lorediplon.

M2 EQUITYBITES-February 8, 2017-Ergomed meets primary endpoint in clinical study of insomnia drug Lorediplon


United Kingdom-based Ergomed has met the primary endpoint in the phase two clinical study assessing Lorediplon with high statistical significance, indicating the drug has strong efficacy in sleep maintainance, it was reported yesterday.

The phase two trial was conducted on 145 adult patients with insomnia disorder, where both 5 and 10mg strengths of the hypnotic drug met the primary endpoint while resulting in statistically important improvement. The drug indicated strong efficacy in sleep maintenance all through the night in comparison to placebo in the double-blind, dose-finding four-way cross-over trial held at 11 European sleep labs.

According to the trial findings, the product was well tolerated with an acceptable safety profile that also featured evaluation of residual effects in the next day. Treatment using the drug sustained natural sleep architecture as per the results.

The product is a non-BZD (benzodiazepine) hypnotic drug that modulates the gamma-Amino Butyric Acid A (GABAa) receptor. It is being developed by the UK based pharmaceutical services and drug development firm jointly with Spanish pharma Ferrer.

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Publication:M2 EquityBites (EQB)
Article Type:Clinical report
Date:Feb 8, 2017
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