Osmotica Pharmaceutical Corp., a pharmaceutical corporation based in Marietta, GA announced that the U.S. FDA granted Orphan Drug Designation to Osmolex ER for the treatment of levodopa induced dyskinesia (LID) for patients with Parkinson’s disease (PD).  Osmolex ER, a proprietary drug formulation of Amantadine HCl Extended Release Tablets utilizing Osmotica’s patented Osmodex technology platform, according to the company’s website. Levodopa is the most effective treatment for PD.  However, long-term use of levodopa especially in young-onset PD patients often leads to the development of LID, a difficult condition to treat due to lack of effective therapeutics.  Currently, the company is sponsoring two Phase III clinical trials evaluating the efficacy and safety of Osmolex ER in PD patients with LID.

 

References:

  1. http://www.businesswire.com/news/home/20150722005672/en#.VbD0luhVhBd
  2. https://clinicaltrials.gov/ct2/results/displayOpt?flds=a&flds=b&flds=f&flds=c&submit_fld_opt=on&term=Amantadine&cond=Levodopa+induced+dyskinesia&show_flds=Y