FDA ( U.S. Food and Drug Administration ) has approved Inbrija ( Levodopa inhalation powder ) for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with Carbidopa / Levodopa.
OFF episodes, also known as OFF periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral Carbidopa / Levodopa, the standard oral baseline Parkinson’s treatment.
In the clinical study program, Inbrija has established its safety profile and has demonstrated clinically meaningful improvements in motor function, as measured by the UPDRS Part III.
FDA approval of Inbrija was based on a clinical program that included approximately 900 people with Parkinson’s on a Carbidopa / Levodopa regimen experiencing OFF periods.
Inbrija is not to be used by patients who take or have taken a nonselective monoamine oxidase inhibitor such as Phenelzine or Tranylcypromine within the last two weeks.
The phase 3 pivotal efficacy trial, SPANSM-PD, was a 12-week, randomized, placebo controlled, double blind study evaluating the effectiveness of Inbrija in patients with mild to moderate Parkinson’s experiencing OFF periods.
The SPAN-PD trial met its primary endpoint, with patients showing a statistically significant improvement in motor function at the week 12 visit, as measured by a reduction in Unified Parkinson’s Disease Rating Scale ( UPDRS ) Part III score for Inbrija 84 mg ( n=114 ) compared to placebo ( n=112 ) at 30 minutes post-dose ( -9.83 points and -5.91 points respectively; p=0.009 ). Onset of action was seen as early as 10 minutes.
The most common adverse reactions with Inbrija ( at least 5% and greater than placebo ) in the pivotal trial were cough ( 15% vs. 2% ), upper respiratory tract infection ( 6% vs. 3% ), nausea ( 5% vs. 3% ) and sputum discolored ( 5% vs. 0% ).
Inbrija was also studied in a phase 3 long-term, active-controlled, randomized, open-label study ( N=398 ) assessing safety and tolerability over one year.
This study showed the average reduction in FEV1 ( forced expiratory volume in 1 second ) from baseline was the same ( -0.1 L ) for the Inbrija and observational cohorts.
Patients with chronic obstructive pulmonary disease ( COPD ), asthma, or other chronic respiratory disease within the last five years were excluded from this study. ( Xagena )
Source: Acorda Therapeutics, 2018