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Inbrija Approval History

Reviewed by J.Stewart BPharm. Last updated on Dec 30, 2018.

FDA Approved: Yes (First approved December 21, 2018)
Brand name: Inbrija
Generic name: levodopa
Dosage form: Inhalation Powder
Company: Acorda Therapeutics, Inc.
Treatment for: Parkinson's Disease

Inbrija (levodopa) is an oral inhalation formulation of the approved drug levodopa for the treatment of OFF episodes in people with Parkinson’s disease taking a carbidopa/levodopa regimen.

  • OFF periods in Parkinson’s disease result from low levels of dopamine between doses of carbidopa/levodopa, and they can be unpredictable and appear more frequently over time. The absorption of oral medication can be variable and contribute to the development of OFF periods. Inbrija enters the bloodstream directly via the lungs and does not depend on absorption in the digestive tract.
  • Inbrija is for oral inhalation only, and the Inbrija capsules must NOT be swallowed. The inhaler can be used up to five times daily, and is breath-actuated so does not need to be pressed or manipulated in coordination with inhalation. The inhaler makes a unique "whirl" (spin) sound so the user knows the inhaler is working and the medicine is being delivered.
  • Inbrija is contraindicated in patients currently taking, or who have recently taken a nonselective monoamine oxidase (MAO) inhibitor. The effectiveness of Inbrija may be reduced in patients taking dopamine D2 receptor antagonists (phenothiazines, butyrophenones, risperidone, metoclopramide), isoniazid, and iron salts or multivitamins containing iron salts.
  • Patients should tell their healthcare provider if they experience the following serious side effects: falling asleep during normal daily activities, withdrawal-emergent hyperpyrexia and confusion, low blood pressure, hallucinations and other psychosis, unusual uncontrollable urges, dyskinesia, and bronchospasm. Inbrija is not recommended in patients with asthma, COPD, or other chronic underlying lung disease.
  • The most common adverse reactions (incidence ≥ 5%) were cough, nausea, upper respiratory tract infection, and discolored sputum.

Development History and FDA Approval Process for Inbrija

DateArticle
Dec 21, 2018Approval FDA Approves Inbrija (levodopa inhalation powder) for Intermittent Treatment of OFF Episodes in People with Parkinson’s Disease
Sep 13, 2018Acorda Announces FDA Extends Inbrija NDA Review Period
Feb 20, 2018Acorda Announces FDA Acceptance of New Drug Application for Inbrija (levodopa inhalation powder)
Dec  7, 2017Acorda Resubmits New Drug Application for Inbrija (CVT-301, levodopa inhalation powder)
Aug 29, 2017Acorda Receives Refusal to File Letter from FDA for Inbrija (CVT-301, levodopa inhalation powder) New Drug Application
Jun 29, 2017Acorda Submits New Drug Application to U.S. Food and Drug Administration for Inbrija (CVT-301, Levodopa Inhalation Powder)
Jun  5, 2017CVT-301 Phase 3 Data Showed Significantly Improved Motor Function During OFF Periods in Parkinson’s Disease
Feb  9, 2017Acorda Announces Positive Phase 3 Clinical Trial Results for CVT-301
Oct 15, 2012Civitas Therapeutics to Present Positive Clinical Study Results for CVT-301 at Sixth Annual Parkinson's Disease Therapeutics Conference, Sponsored by The Michael J. Fox Foundation for Parkinson's Research
Jan 10, 2012Civitas Therapeutics Announces Positive Results from Clinical Study of CVT-301, an Inhaled L-dopa for Parkinson's Disease

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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