Adamas Pharmaceuticals is claiming success with a Phase II/III study of its extended-release version of amantadine for Parkinson's disease. Investigators say that the lead drug--ADS-5102, reformulated in a way designed to reduce the severity of side effects that plague patients--demonstrated a statistically significant improvement in levodopa-induced dyskinesia when compared with a placebo after 8 weeks of therapy.
The treatment is provided on a once-nightly basis so it can trigger only low plasma levels overnight and reduce the insomnia, sleep disturbances and vivid dreams occasionally associated with amantadine, a drug sold by Endo. And both the 340 mg and the 420 mg arms improved dyskinesia in Parkinson's patients, according to the biotech.
"For Parkinson's disease patients suffering from the dyskinesia side effects of levodopa treatment, reducing the time and severity of these effects has been a long-term goal in their treatment. ADS-5102 demonstrated a significant reduction in the duration and severity of troublesome dyskinesia among PD patients with levodopa-induced dyskinesia in this well-designed, controlled clinical study," said Rajesh Pahwa, a professor of neurology at the University of Kansas Medical Center and an investigator for the EASED study. "The clinical results seen in this study of ADS-5102 are extremely encouraging and have the potential to make a difference in patients' lives."
Adamas has maintained a relatively low profile in the biotech industry over the years, but registered headlines for the $160 million dollar deal--$65 million upfront--it struck last fall with Forest Labs to develop a fixed-dose combination of Namenda XR and donepezil HCl for Alzheimer's dementia. Adamas raised a $40 million round in 2009.
- here's the press release