Adamas says lead drug meets late-stage study goals

By Anjali Rao Koppala (Reuters) - Drugmaker Adamas Pharmaceuticals Inc's experimental treatment to reduce the side effect of a commonly prescribed Parkinson's drug met the main goal of a late-stage study, sending its shares up as much as 58.5 percent. Shares of the company jumped to $26.72 in Wednesday morning trade. The company was trading at similar levels in June when it reported additional findings from a mid-stage trial of the same drug, but pared most of its gains. The company said on Wednesday that its drug, amantadine HCl, significantly reduced dysfunctional movement, a side effect of levodopa, a drug used to treat Parkinson's patients. Adamas expects to file for marketing approval of the drug next year, the company's Chief Executive Gregory Went said on a call with analysts. The company is committed to market the drug themselves on approval, he said. About 50,000 Americans are affected by Parkinson's each year, according to the National Institutes of Health. The disease causes reduced levels of the hormone dopamine in the brain, which leads to poor mobility, slowness and stiffness. Nearly all patients diagnosed with Parkinson's are treated with levodopa. The effectiveness of oral levodopa, however, is limited by the short time it stays in the body. Excessive oral doses often lead to involuntary movements, or dyskinesia. Patients treated with the drug showed 23 percent reduction in dysfunctional movement at twelve weeks compared to placebo, the company said on Wednesday. The drug had received orphan drug status from U.S. Food and Drug Administration in April, which gives it several incentives including seven-year marketing exclusivity. However, amantadine HCl has been available in the market as an antiviral drug since 1968. Minnesota-based Upsher-Smith Laboratories has two oral versions of amantadine HCl approved in the market since 1987. Privately held Osmotica Pharmaceutical Corp is testing Osmolex ER, currently in a mid-stage trial, to treat the levodopa induced side effect. Emeryville, California-based Adamas said it is also conducting another late-stage study to evaluate effectiveness of 340 mg dose of amantadine HCl given once daily at bedtime. (Reporting by Vidya L Nathan and Anjali Rao Koppala in Bengaluru; Editing by Shounak Dasgupta)