Acorda Therapeutics will soon release novel data on its Phase 3 SPAN-PD trial (Study 004, NCT02240030) investigating the experimental drug Inbrija (CVT-301) as a potential therapy for patients with Parkinson’s disease.
Acorda presents its poster, “Inhaled levodopa (CVT-301, 84-mg dose) significantly improves motor function during OFF periods in Parkinson’s disease subjects: A Phase 3 Study (SPAN-PD),” June 5 at the International Congress of Parkinson’s Disease and Movement Disorders in Vancouver.
Inbrija is an inhaled formulation of levodopa (L-dopa) under development to treat “off” episodes, or re-emergence of Parkinson’s motor symptoms, in patients taking oral carbidopa/levodopa. It delivers a precise amount of the medication into the lungs and reaches the brain shortly after.
The SPAN-PD trial enrolled 351 Parkinson’s patients experiencing “off” episodes to evaluate the safety and effectiveness of inhaled Inbrija compared to a placebo. Researchers assessed the drug’s effectiveness by changes in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III motor score, a measure of motor impairment, at 30 minutes following treatment with 84 mg of Inbrija at 12 weeks.
Results showed that patients on Inbrija reported a change of -9.83 compared to -5.91 for placebo, which indicated improvement of motor function.
Two other Phase 3 studies investigated the long-term safety of Inbrija: CVT-301-005 (NCT02352363) and CVT-301-004E (NCT02242487). The CVT-301-005 study enrolled 271 Parkinson’s patients with no history of asthma or other chronic lung disease, to assess pulmonary function after one year of treatment.
The CVT-301-004E study included 149 patients who were given 84 mg of CVT-301 and 146 patients who were treated with 60 mg. Safety findings were similar to those reported in the CVT-301-005 study. These patients were given Inbrija (84 mg) up to five times a day and standard of care. Results were compared to those of 127 patients who received only standard of care (control group). No difference has been found between the two groups, showing that treatment with Inbrija does not change pulmonary function in Parkinson’s patients.
Common side effects included mild to non-severe cough, nasopharyngitis (cold), dyskinesia (involuntary movements) and falls.
Acorda, based in Ardsley, New York, plans to ask the U.S. Food and Drug Administration for a New Drug Application. It’ll also file a Marketing Authorization Application (MAA) to the European Medicines Agency this year to treat Parkinson’s patients with Inbrija, and plans to support its applications by the positive results obtained in the Phase 3 studies.
“We are excited to be preparing an NDA in the U.S. and an MAA in the EU, which we plan to submit by the end of the second quarter and end of the year, respectively,” Dr. Burkhard Blank, Acorda’s chief medical officer, said in a press release. “Data from our clinical program have shown that Inbrija has the potential to be an important new treatment option for people with Parkinson’s who experience off periods, which can be extremely disruptive in their lives.”