Adamas provides updated results from pivotal Parkinson's study

Californian biotech firm Adamas Pharmaceuticals (Nasdaq: ADMS) has presented updated efficacy and tolerability data from an ongoing Phase III study of ADS-5102 (amantadine) as a Parkinson’s disease treatment.

Results demonstrated that the drug candidate was well tolerated, and that the treatment effect on motor complications was maintained for up to 88 weeks.

"The expanded analysis out to 88 weeks provides continued support for the long-term safety and tolerability of ADS-5102, as evidenced by a minimal discontinuation rate, and the maintenance of a reduced and nearly constant level of dyskinesia and OFF for over 12 months,” said chief medical officer Rajiv Patni.

“If approved, ADS-5102 will be the first and only FDA-approved medicine indicated for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease, and we look forward to making this treatment available to patients in need."

The safety data are consistent with the previously reported safety profile of ADS-5102 and the known safety profile of amantadine, which includes precautions and warnings related to suicidality, hallucinations and dizziness.

ADS-5102 is a high-dose amantadine, taken once daily at bedtime, in development for the treatment of LID in people with Parkinson's disease.

A New Drug Application (NDA) supporting ADS-5102 for the treatment of levodopa-induced dyskinesia in people with Parkinson's disease is under review by the US Food and Drug Administration (FDA), with a decision expected by August 24, 2017.