Osmotica Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to Osmolex ER (amantadine extended release tablets) for the treatment of levodopa induced dyskinesia (“LID”) for patients with Parkinson’s disease.
Osmolex ER utilizes Osmotica’s proprietary Osmodex drug delivery technology. Osmotica is also investigating the use of Ontinua ER in a Phase 3 trial for the treatment of spasticity in patients with multiple sclerosis.
The company anticipates filing the New Drug Application (NDA) for Osmolex in 2016.
For more information visit Osmotica.com.