Merck unveils Phase 3 data for BELSOMRA C-IV in treatment of insomnia

It is the first dedicated Phase 3 polysomnography study for the treatment of insomnia in people having mild-to-average Alzheimer’s disease and dementia

Pharmaceutical company Merck, also known as MSD outside Canada and the United States, has recently presented the Phase 3 trial results for evaluation of the safety and efficacy of BELSOMRA (suvorexant) C-IV for treating insomnia in individuals with mild to average Alzheimer’s disease dementia.

Sources familiar with the matter informed that this presentation is the first dedicated Phase 3 polysomnography study for the treatment of insomnia in people having mild-to-average Alzheimer’s disease and dementia. In the trial run, BELSOMRA achieved its primary and secondary efficacy endpoints.

Reportedly, in case of primary endpoint, 4-weeks of treatment with BELSOMRA improved average total sleep time by 28.2 minutes. This corresponded to a mean increase from baseline of 45.2 minutes with placebo and a mean increase from baseline of 73.4 minutes with BELSOMRA. Adverse events were reported in 16.1% of patients receiving placebo compared to 22.5% of those receiving BELSOMRA.

Seemingly, the presentation results are being presented at the 2019 Annual Meeting of American Academy of Neurology, held between May 4 to 10 in Philadelphia, PA.

According to associate vice president of Global Clinical Research, Neuroscience, Merck Research Laboratories, Dr. W. Joseph Herring, insomnia and other kind of sleep disturbances are very common in people with Alzheimer’s disease dementia.

Dr. Herring said evidence for the safety and efficacy of sleep medications in this population remains restricted. Merck aims to file these data with the USFDA, (United States Food and Drug Administration) for potentially including in the BELSOMRA prescribing info.

BELSOMRA C-IV 20 mg,15 mg,10 mg, 5 mg tablets are presently approved by the USFDA for the treatment of insomnia in people who are struggling with sleep maintenance and sleep onset, sources added. The Phase 3 trial comprised of a 3-week screening period along with a 2-week single blind placebo run and was also followed by a 4-week double blind randomized treatment phase.

 

Source Credit: https://www.streetinsider.com/Corporate+News/Mercks+%28MRK%29+BELSOMRA+C-IV+Meets+Primary+Efficacy+Endpoint+in+Phase+3+Trial+for+Treatment+of+Insomnia+in+People+with+Mild-to-Moderate+Alzheimer%E2%80%99s+Disease+Dementia/15461085.html

https://www.mrknewsroom.com/news-release/research-and-development-news/mercks-belsomra-suvorexant-c-iv-meets-primary-efficacy-en