Advertisement Adamas' ADS-5102 gets FDA orphan drug status for LID associated with Parkinson's disease - Pharmaceutical Business review
Pharmaceutical Business review is using cookies

ContinueLearn More
Close

Adamas’ ADS-5102 gets FDA orphan drug status for LID associated with Parkinson’s disease

The US Food and Drug Administration (FDA) has granted orphan drug status for Adamas Pharmaceuticals' product candidate ADS-5102 to treat levodopa-induced dyskinesia (LID) associated with Parkinson's disease (PD).

Currently, the company has multiple Phase III trials underway evaluating ADS-5102 for this indication, which currently has no FDA-approved treatment options.

ADS-5102 (amantadine HCl) is a high dose, extended-release version of amantadine that is administered once daily at bedtime.

Initially, the company is developing ADS-5102 for the treatment of LID, a complication that frequently occurs in patients after long-term treatment with levodopa, the most widely used drug for PD.

Adamas Pharmaceuticals chairman and CEO Gregory Went said: "People with Parkinson’s disease contend with the disability associated with levodopa-induced dyskinesia multiple times a day as the disease progresses and their motor symptoms fluctuate.

"Adamas is committed to bringing new treatments to patients suffering with movement disorders related to neurological disorders. With positive data from our Phase II/III study, a pivotal Phase III program well underway, and 10 issued US patents, we are pleased with our ongoing momentum."

Currently, there are no approved drugs for the treatment of LID in the US or Europe.