The US Food and Drug Administration (FDA) approval of Inbrija (levodopa) for the treatment of OFF episodes in people with Parkinson’s disease comes after “two decades of research and development”, according to Ron Cohen, Acorda president and CEO in a statement.
Christopher Kenney, senior vice president of medical affairs at Acorda, told us, that Inbrija is the only FDA approved inhaled formulation of levodopa. He continued, “The route of administration is critical to avoid problems with inconsistent absorption with oral medications. The levodopa is delivered through the lungs to the brain and converted to dopamine to supplement the loss of endogenous dopamine inherent in Parkinson’s disease.”
The approval also comes after clinical study programs established Inbrija’s safety profile and clinically meaningful improvements in motor function for individuals with Parkinson’s disease having OFF episodes.
Inbrija is approved for the on-demand use based on individual patient need. Inbrija is manufactured with the company’s proprietary ARCUS technology at its facility in Boston, it is expected to be available in the US in the first quarter of 2019.
The clinical study program included around 900 people with Parkinson’s on a standard medication regimen experiencing OFF periods.
OFF episodes in people with Parkinson’s disease are defined by the return of symptoms as a result of low levels of dopamine between doses of the standard oral baseline treatment.
Primary endpoints of the study showed patients had a statistically significant improvement in motor function. Additionally, the onset of action for Inbrija was seen in 10 minutes.
According to Kenney, this is approval is a milestone for approximately 350,000 people with Parkinson’s who are currently taking the standard medication and still experiencing OFF periods.
Todd Sherer, CEO of the Michael J. Fox Foundation, said in a statement that funding for early clinical development of Inbrija was provided by the foundation, as many patients expressed that OFF periods were one of the most serious issues they were facing.
Kenney also told us that the ARCUS technology Acorda uses for the development of Inbrija is currently being explored for the treatment of migraines.