Takeda (NYSE:TAK) has won breakthrough therapy designation from FDA for TAK-994, an experimental oral orexin agonist. Now in a Phase 2 trial, TAK-994 is formulated to selectively target orexin 2 receptors. Orexin is a neuropeptide that supports normal wakefulness. Orexin deficiency is associated with narcolepsy.
Takeda is testing the potential of TAK-994 to treat excessive daytime sleepiness in people with narcolepsy type 1 (NT1), which involves a disturbance of sleep-wake cycles and the presence of cataplexy. Cataplex itself involves a sudden muscle weakness occurring when a person is awake.
Currently, the majority of therapies for NT1 are repurposed, including a range of stimulants and antidepressants. In addition, FDA has indicated sodium oxybate (Xyrem) for cataplexy in narcolepsy and excessive daytime sleepiness, which is effective but has a risk of respiratory depression and has significant potential for abuse.
Following the announcement, Takeda shares ticked up 2.39%, or $0.40, to $17.17, in mid-afternoon trading.
Filed Under: clinical trials, Drug Discovery, Neurological Disease