FDA Approves Inbrija™ (levodopa inhalation powder)
December 22, 2018
Acorda Therapeutics announced the FDA approval of INBRIJA™ (levodopa inhalation powder) for the treatment of OFF periods in people with Parkinson’s disease (PD) taking carbidopa/levodopa. INBRIJA™ is expected to be available by prescription in the first quarter of 2019, to be distributed through a network of specialty pharmacies. Approval of any medication comes after a long process in which the drug is first developed and then tested in clinical trials. The results of the clinical trials, along with all other information about the potential new drug are reviewed extensively by the FDA before approval.
INBRIJA™ is meant to be used by a person with PD as needed if he/she is affected by an OFF period. OFF periods refer to times during the day in which a person with PD experiences a return of his/her PD symptoms. These periods may come on slowly between regularly scheduled carbidopa/levodopa doses or abruptly at unpredictable times. For more information on OFF periods in PD, please see this recent APDA webinar.
INBRIJA™ is administered via an inhalation pump. The inhaler releases INBRIJA™ into the lungs without needing to be pressed or manipulated in coordination with inhalation.
The approval of INBRIJATM is very exciting as it gives PD patients a novel approach to the treatment of OFF periods. The following is Acorda’s press release announcing the approval.