Acorda Therapeutics, Inc. issued the following announcement on April 16.
Acorda Therapeutics, Inc. will present new data for INBRIJA during four oral platform presentations at the upcoming American Academy of Neurology Annual Meeting in Los Angeles, taking place April 21–27, 2018. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen.
“We are delighted to have the opportunity to present data from our Phase 3 clinical development program for INBRIJA, an investigational treatment for people with Parkinson’s living with OFF periods, or the re-emergence of Parkinson’s symptoms.
To date, INBRIJA has been studied in more than 800 people with Parkinson’s worldwide,” said Burkhard Blank, M.D., Acorda's Chief Medical Officer. “OFF periods are one of the most disruptive aspects of Parkinson’s and there is a tremendous unmet need for new treatment options to address them.”
The INBRIJA data will be presented on Tuesday, April 24, 2018, during Session S26: Movement Disorders - Parkinson’s Disease Clinical Trials from 3:30 PM – 5:30 PM PT. Details are as follows:
| PRESENTATION TIME | ABSTRACT # | TITLE | PRESENTER | |||||||||
| 4:06 PM PT | 3102 | Inhaled Levodopa Administered With Oral Carbidopa/Levodopa for Early Morning OFF Symptoms in Patients with Parkinson’s Disease: Exploratory Efficacy Analysis | Stuart H. Isaacson, MD | |||||||||
| 4:18 PM PT | 3008 | Inhaled Levodopa Administered With Oral Carbidopa/Levodopa for Early Morning OFF Symptoms in Patients with Parkinson’s Disease: Safety Assessment | Robert A. Hauser, MD | |||||||||
| 4:30 PM PT | 1484 | Long-Term Pulmonary Safety of Inhaled Levodopa in Parkinson’s Disease Subjects with Motor Fluctuations: a Phase 3 Open-Label Randomized Study | Charles Oh, MD | |||||||||
| 4:54 PM PT | 1454 | Long-term Efficacy of Inhaled Levodopa in Parkinson’s Disease Subjects with Motor Fluctuations: a Phase 3 Open-Label Randomized Study | | Charles OH, MD |
A New Drug Application for INBRIJA was accepted for review by U.S. Food and Drug Administration in February 2018, and FDA has set a target PDUFA date of October 5, 2018.
Acorda will also present data from the Phase 3 tozadenant clinical trial on Monday, April 23, 2018, during Session P2: Movement Disorders, Poster Presentation #045 between 11:30 AM and 7 PM PT.
Original source can be found here.
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