AbbVie's experimental drug to treat early Parkinson's disease met the main goal in a late-stage study, the drugmaker said.
The study tested the safety and efficacy of flexible doses of the drug, tavapadon, ranging from 5 milligrams (mg) to 15 mg, as a monotherapy.
AbbVie acquired tavapadon through its $8.7 billion purchase of Cerevel Therapeutics last year to offset declining sales of its arthritis treatment Humira, once the world's top-selling medicine.
In September, two fixed doses of tavapadon as a monotherapy had shown statistically significant improvement in patients in a late-stage study.
In both the studies, the experimental drug helped to significantly improve daily motor functions, including eating and walking, as well as in activities such as rising from a chair and maintaining a stable posture, the company said.
The majority of side effects reported, such as nausea, headache, and dry mouth, were mild to moderate in severity.
AbbVie plans to submit a marketing application to the U.S. Food & Drug Administration next year.
The study enrolled 304 adults between the ages of 40 and 80, who had the disease for less than three years.
Tavapadon is being studied as a once-daily treatment for Parkinson's disease. Earlier this year, tavapadon improved symptom control in patients when tested as an add-on therapy to levodopa, the standard of care for the disease, in a late-stage trial.
In October, the FDA had approved AbbVie's Vyalev, the first levodopa-based therapy administered as an under-the-skin in Content jection to treat symptoms associated with advanced forms of the disease in adults.
