Inhaled Levodopa Impresses in Treating Parkinson’s OFF Periods in Phase 3 Study

Friday, February 10, 2017 | Movement Disorders , Phase 3/4 Trials


New phase 3 data suggests that the experimental inhaled levodopa, CVT-301 (Acorda Therapeutics), may offer significant improvement in motor function in individuals with Parkinson’s disease experiencing OFF periods. The SPAN-PD trial randomized 339 people with Parkinson's disease who experience motor fluctuations to receive one of two doses of CVT-301 or placebo. All participants were on a stable regimen of oral carbidopa and levodopa, and were also maintained on their other existing Parkinson's disease therapies. Results showed that the UPDRS III change for the higher dose of CVT-301 was -9.83 compared to -5.91 for placebo. Meanwhile, key secondary endpoints, measured at week 12, include the proportion of participants achieving an ON state within 60 minutes of treatment and maintained at 60 minutes, as well as change in UPDRS III score at 10 and 20 minutes following treatment.

Acorda Therapeutics is conducting two studies to assess the long-term safety profile of CVT-301, with up to 12-month data expected soon. The company also indicated that it plans to seek FDA approval of the therapy, which is an inhalable formulation of levodopa, by the end of the second quarter, with an application in Europe targeted by the end of the year.

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