The FDA approved levodopa inhalation powder (Inbrija) for on-demand use during "off" episodes in people with Parkinson's disease taking an oral carbidopa-levodopa regimen, Acorda Therapeutics announced.
These "off" periods are defined as the return of Parkinson's symptoms when dopamine levels are low between carbidopa-levodopa doses. For faster action, the levodopa powder bypasses liver metabolism as it moves from the lungs to the bloodstream.
The FDA nod came after the phase III SPAN-PD pivotal efficacy trial showed a significant improvement in motor function at 12 weeks -- as assessed by Unified Parkinson's Disease Rating Scale (UPDRS) Part III scores 30 minutes after dosing -- among patients who used 84 mg of inhaled levodopa compared with placebo (-9.83 vs -5.91, P=0.009). For some patients, onset of action was as early as 10 minutes. The most common adverse reactions were cough, upper respiratory tract infection, nausea, and discolored saliva or spit.
A phase III open-label study also assessed the safety and tolerability of inhaled levodopa (formerly CVT-301) over 12 months and showed that the average reduction in forced expiratory volume in 1 second (FEV1) from baseline was the same for the inhaled levodopa group as an observational control group. Patients with chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory diseases within the last 5 years were not included in this study.
An FDA decision about this levodopa inhalation powder was expected in October, but in September, the agency extended its time frame to review additional information about the drug's chemistry and manufacturing.
In an Acorda press release, Todd Sherer, PhD, CEO of the Michael J. Fox Foundation -- which funded early studies of inhaled levodopa -- said "patients told us that 'off' periods were one of their most serious issues. We knew we had to help address this unmet need, and this approval is a significant step forward for the community as it provides a new option to manage these gaps in symptom control."
Inhaled levodopa is not for patients who have used a nonselective monoamine oxidase inhibitor such as phenelzine (Nardil) or tranylcypromine (Parnate) in the last 2 weeks.
Full prescribing information is online at:
http://www.inbrija.com/prescribing-information.PDF
The drug should be available in the first quarter of 2019.
https://www.medpagetoday.com/neurology/parkinsonsdisease/77104
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