New Insomnia Drug - Merck has announced positive results in a phase 3 trial of its insomnia drug. It's a key player in the companies up and coming products, especially considering the loss of patent protection on its top drugs for asthma and allergys.
The experimental drug known as suvorexant, uses a new mechanism created to help people sleep, but at the same time aiming to mitigate side effects associated with popular sleep aids. Analysts think that annual sales of the drug could top $500 million within several years.
The studies tested whether suvorexant extended total sleep time, & also looked for improvements in other measures of insomnia versus patients taking a placebo.
Merck confirmed that it's now completed late-stage, or Phase three patient studies of the drug, which ended with positive results.
The company didn't go in to details today, but designs to present the findings at medical meetings later this year. Merck will also file a brand spanking new drug application with the U.S. Food & Drug Administration this year. In fact Suvorexant is of the major U.S. filings Merck anticipates for 2012 & 2013.
It is a more avante garde approach than older insomnia drugs known as benziodiazepines, as well as newer drugs like Sanofi's (SNY, SAN.FR) Ambien, which targets so-called GABA receptors present in the brain.
These older drugs fundamentally depress the central-nervous system, but they can lead to dependence, or have withdrawal effects, such as drowsiness in the morning.
Suvorexant in lieu targets the brain's arousal symptom, temporarily switching it off, but hoping to keep away from depressing the central nervous system.
In earlier testing, the most common adverse events included positive infections, drowsiness after waking up & vivid dreams.
