AbbVie, an American Biopharmaceutical company, has submitted an application to the U.S. Food and Drug Authority (FDA) for a treatment developed for Parkinson’s disease.
The treatment, identified as ABBV-951 is a subcutaneous drug (to be administered under the skin with a needle) and has shown potential to improve the motor functions of Parkinson’s disease patients. The treatment has to be delivered on an ongoing 24 hours basis.
The application to the FDA was made after AbbVie (foscarbidopa/foslevodopa) received positive results from its clinical trial. In the Phase III trial, the drug was able to provide statistically significant results against a placebo with a sample size of 130 adults.
The trial was randomized, controlled and spanned over 12 weeks across 80 sites in both the U.S. and Australia. The participants either received ABBV-951 solution continuously subcutaneously, continuous subcutaneous placebo, or oral placebo tablets.
In comparison to the oral placebo (carbidopa/levodopa), ABBVie’s developed treatment showed statistically significant betterment of motor fluctuations- or dyskinesia in patients.
The company explained its goal to engage fully in meeting the need for Parkinson’s disease treatments as the patients of the disease need treatments urgently due to the immobilizing nature of the disease.
“Advanced Parkinson’s disease causes unrelenting challenges and uncertainty for patients and caregivers worldwide,” ABBVie Senior Vice President of research and development further added “We are committed to addressing the unmet needs of those affected by the disease and recognize the urgency for a new treatment that can enable better symptom control through the continuous 24-hour administration of medication.”
ABBV-951 is a solution of the combination of two drugs foscarbidopa and foslevodopa and needs to be administered to patients around the clock for the observed improvement in motor functions.
After comparison with the immediate release of carbidopa/levodopa oral tablet, the results show ABBV-951’s potential as a treatment for dyskinesia.
The trial also evaluated the safety of the developed treatment. It was found that the drug solution had no serious adverse effects and any reported were mild to moderate in severity. The treatment sample that received the placebo solution of carbidopa/levodopa reported one death.
The findings from this 130-person clinical trial were further supported by another clinical trial which is multicenter, open-label, and single-arm aimed to gauge the safety of the treatment over a longer period, as well as its efficacy.
An AbbVie representative sympathized with Parkinson’s patients, describing the challenges both the patients of the disease face but also the families of the patients. Due to the disease’s progressive and devastating nature, it becomes quite difficult for both caregivers and patients.
The biopharmaceutical company AbbVie has plans to pursue regulatory approvals and clearances for world markets this year.
Another development of the company is related to the autoimmune and inflammatory disease side, with AbbVie landing an exclusive worldwide licensing deal for CUG252, Cugene’s developed treatment.