Patients with a movement disorder known as tardive dyskinesia saw a reduction in spasms after taking Neurocrine Biosciences’ experimental drug NBI-98854 for six weeks compared to patients taking a placebo. The drug company says it hopes the promising data will win Food and Drug Administration (FDA) approval to move forward with a late-stage study during the first half of the year.
Tardive dyskinesia is a difficult to treat and often incurable neurological disorder that causes involuntary movements such as grimacing, tongue movements, lip smacking and puckering, pursing of the lips, and excessive eye blinking. The condition most often occurs as a side effect of long-term or high-dose usage of antipsychotic drugs as well as the acid reflux medication Reglan.
NBI-98854 is a small molecule VMAT2 inhibitor designed to provide low, sustained, plasma and brain concentrations of the active drug to minimize side effects associated with excessive monoamine depletion.
For the study, physicians rated their patients’ tardive dyskinesia symptoms after taking the drug or a placebo. They found that 67 percent of patients were “much improved” or “very much improved” after six weeks compared to just 16 percent in the placebo group.
Neurocrine Biosciences Inc. has no drugs currently in the market however it does have some in the pipeline including its most promising candidate, the drug elagolix, a treatment for endometriosis and uterine fibroids. That drug is currently being tested in late-stage trials by AbbVie Inc.