- If Neurocrine Bioscience's investigational drug is approved, it will be the first FDA-approved treatment for tardive dyskinesia (TD), an involuntary movement disorder.
- TD is a condition that generally affects patients who are being treated with antipsychotics. It occurs as a stigmatizing side effect in 10% of treated patients.
- Neurocrine plans to submit its application to the FDA in 2016 and hopes to launch in 2017. Revenue estimates are $1.15 billion per year.
For the roughly 600,000 people in the U.S. who develop TD as a side effect of antipsychotic treatment, the stigma can be very difficult. Although the pathophysiology of TD is not completely understood, those who are older, female, or African American are more at-risk for developing TD, which is widely recognized as an unmet medical need.
Neurocrine is still preparing its submission dossier. In addition to strong efficacy data, the company is adding on one-year safety data, as well as more phase 3 data to round out its application.
Even though the company is still months away from filing, some analysts are already calling Neurocrine's TD drug a potential blockbuster based on an anticipated price of $45,000 per year.