On 7 May, Merck, a leading global biopharmaceutical company known as MSD outside of the US and Canada, presented positive results of its Phase III trial evaluating BELSOMRA® (suvorexant) for insomnia in people with mild to moderate Alzheimer’s disease (AD) dementia at the 2019 American Academy of Neurology Annual Meeting in Philadelphia (US). BELSOMRA® (suvorexant) is currently approved in the US for the treatment of insomnia characterised by difficulties with sleep onset and sleep maintenance.
The Phase III study is a randomised and placebo-controlled clinical trial investigating the safety and efficacy of suvorexant for the treatment of insomnia in people with mild to moderate AD. It included 136 participants who received suvorexant 10 mg and 141 participants who received placebo. Of the patients treated with suvorexant, 77% increased their dose from 10 mg to 20 mg after the second week of the trial.
The company reported that the trial met both its primary and secondary efficacy endpoints. For the primary endpoint, treatment with suvorexant over four weeks led to an improved mean total sleep time by 28.2 minutes versus placebo. For the secondary efficacy endpoint measurement, an improvement in wake after persistent sleep onset (WASO) was observed in the suvorexant group compared with placebo (15.7 minutes improvement for the drug). During the study, adverse events were observed in 22.5% of participants receiving suvorexant compared to 16.1% of those receiving placebo.