Positive Top-Line Results for Inhalable Version of Parkinson's Drug in SPAN-PD Trial

Deborah Brauser

February 09, 2017

Top-line results are positive for the experimental Parkinson's disease (PD) treatment CVT-301 in the phase 3 SPAN-PD trial, according to an announcement today from Acorda Therapeutics. The company hopes to seek approval from the US Food and Drug Administration (FDA) soon, the statement adds.

CVT-301 is an inhalable version of the oral drug levodopa, commonly used to treat PD symptoms. The new formulation has been investigated as a treatment for the re-emergence of Parkinson's symptoms in so-called "off periods" in patients already taking an oral carbidopa-levodopa regimen, noted the company.

SPAN-PD included more than 300 participants with motor fluctuations. Its primary endpoint, significant improvement in motor impairment vs placebo at week 12, was met by those who received 84 mg of the study treatment.

"Managing symptoms of OFF periods continues to be a significant unmet need," lead investigator Peter A. LeWitt, MD, director of the PD and Movement Disorders Program at Henry Ford Hospital, West Bloomfield, Michigan, said in the release.

"Delivering levodopa by the pulmonary route offers an important treatment option," said Dr LeWitt.

In safety analysis, there were "no notable pulmonary safety signals," reported the company. It added that two other studies are assessing long-term safety of the treatment — and their 12-month data are expected to be released in the first quarter of this year.

On the basis of those findings and on the SPAN-PD results, Acorda plans to file a New Drug Application in the United States in the second quarter of 2017 and a Marketing Authorization Application in Europe by the end of the year.

Dry Powder Formulation Results

The new treatment "delivers a precise dose of a dry powder formulation" of levodopa through the lungs. This means a dose is delivered faster than the oral version, which goes through the digestive system first, notes the manufacturer.

The SPAN-PD trial had three randomized treatment groups: 60-mg (n = 113) and 84-mg (n = 114) doses of CVT-301 and placebo (n = 112). The Unified PD Rating Scale-Part 3 (UPDRS III) was used to measure motor impairment.

The change at week 12 in UPDRS III score was –9.83 for the subgroup receiving the 84-mg dose vs –5.91 for the placebo group (P = .009).

And no "notable" pulmonary safety signals were found in spirometry and diffusing capacity of the lung for carbon monoxide tests.

Serious adverse events were reported in 5.3% of the 60-mg group, 2.7% of the placebo group, and 1.8% of the 84-mg group. Although there was one death in the lower-dose group, it was a suicide that was judged not to be treatment related.

The most common nonserious adverse event was cough, reported by 15% of each of the study-drug groups vs 2% of the placebo group.

However, this was "typically mild and reported once per participant during the course of treatment," said the company. Still, 3 of the patients receiving the study drug dropped out because of cough.

Table. Other Adverse Events Reported by More Than 5% of a Study Group

Adverse Event CVT-301 60 mg CVT-301 84 mg Placebo
Upper respiratory tract infection (%) 1.8 6.1 2.7
Throat irritation (%) 7.1 0.9 0
Nausea (%) 0 5.3 2.7
Discolored sputum (%) 0 5.3 0

 

"We are greatly encouraged by the efficacy and safety results of this trial, which validate the positive phase 2b results," Burkhard Blank, MD, chief medical officer at Acorda, said in the release.

Medscape Medical News reported on positive phase 2 results presented at the 2015 International Congress of Parkinson's Disease and Movement Disorders.

Full findings from the phase 3 SPAN-PD trial, including key secondary endpoints as well as efficacy results for the lower dose, are expected to be presented at a future medical conference.

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