Acorda says it is preparing NDA and MAA for Inbrija inhaled L-dopa, will present new data from Phase 3 trial

Acorda Therapeutics will present new data from a Phase 3 trial of its CVT-301 inhaled L-dopa, which it is now calling Inbrija, at the International Congress of Parkinson’s Disease and Movement Disorders (MDS).

The company has previously said that data from the Phase 3 SPAN-PD trial show that CVT-301 significantly improves motor function in Parkinson’s Disease patients experiencing OFF periods.

CVT-301 was initially developed by Civitas Therapeutics which was acquired by Acorda in 2014.

Acorda Chief Medical Officer Burkhard Blank commented, “We are excited to be preparing an NDA in the US and an MAA in the EU, which we plan to submit by the end of the second quarter and end of the year, respectively. We will present additional findings from the Phase 3 Inbrija study at the MDS Congress, including key secondary measures. Data from our clinical program have shown that Inbrija has the potential to be an important new treatment option for people with Parkinson’s who experience OFF periods, which can be extremely disruptive in their lives.”

Read the Acorda Therapeutics press release.

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