The US subsidiary of the Japanese pharmaceutical company, Eisai Co., Ltd., announced the approval of the US Food and Drug Administration (FDA) for its insomnia treatment for adults.
The approved drug is called Dayvigo and could be distributed in doses of 5 mg and 10 mg based on the studies that tested the drug on patients with insomnia. The newly approved drug was classified as a new class of medication that targets the orexin system. Now, Dayvigo has joined the likes of Belsomora (made by Merck & Co.), which was approved back in 2014.
According to Eisai, Dayvigo has an effect on the neurotransmitter of the brain, suppressing the wake drive. Hence, this drug does the opposite of existing insomnia medications which increase one’s sleep drive, targeting the brain’s sleep centers.
However, the USFDA classified Dayvigo as a controlled substance since it has the potential to be abused, and eventually, cause addiction. Eisai then submitted this recommendation to the US Drug Enforcement Administration (DEA). It usually takes 90 days for the DEA to schedule Dayvigo; after that, Eisai plans to launch the drug, probably somewhere around April 2020.
Based on the late-stage trials, patients who were on Dayvigo didn’t experience changes in their postural stability, memory, and balance during their activities the next day. Despite this, Eisai warned that people must exercise caution when taking the 10 mg dose of Dayvigo; difficulties when driving might occur the next day after taking the medication.
In addition, the drug is not suitable for patients with narcolepsy as it could impair daytime wakefulness and lead to complex sleep behaviors.
The company is currently testing Dayvigo on other sleep disorders such as Alzheimer’s disease and working on getting the drug approved in Canada and Japan. Eisai also revealed that Dayvigo was an important addition to their neurology portfolio. As the first FDA-approved drug that reported safety data within 12 months, Dayvigo just proved the company’s leadership in neuroscience.
Eisai aims to sell the drug independently in the US and beyond and has already reached out to possible health insurers. The company would provide copay cards — known as savings programs offered by drugmakers — to help patients in reducing out-of-the-pocket costs and afford expensive medications.