AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson’s Disease

— The pivotal Phase 3, randomized, double-blind, double-dummy, active-controlled study of continuous, subcutaneous infusion of ABBV-951 (foslevodopa/foscarbidopa) in patients with advanced Parkinson’s disease met its primary endpoint in a 12-week study
— Patients who received 24 hours/daily ABBV-951 showed statistically significant increases in hours of “On” time without troublesome dyskinesia, compared to oral levodopa/carbidopa. A significant reduction in hours of “Off” time was also observed
— Systemic adverse events were generally consistent with the well-established safety profile of levodopa/carbidopa medications and infusion site adverse events were mostly non-serious and mild or moderate in severity
— Data from this head-to-head superiority study will be a key component of global regulatory submissions

AbbVie Announces ABBV-951 (Foslevodopa/ Foscarbidopa) Showed Enhancement in Controlling Motor Oscillations Compared to Oral Levodopa/ Carbidopa Drug in Vital Phase 3 Trial in Cases with Advanced Parkinson’s Disease
— The vital Phase 3, randomized, double-eyeless, double- dummy, active-controlled study of n 0.0083).1 Advancements in”On” time were observed as early as the first week and persisted throughout the 12 weeks.1 It was also observed that an enhancement from birth in hours of average diurnal regularized”Off” time followed a analogous pattern in reductions versus oral LD/ CD after the first week and persisting through week12.1 Decreases in”Off” time after 12 weeks were2.75 hours for ABBV-951 versus0.96 hours for oral LD/ CD (p = 0.0054).1

“Parkinson’s complaint is a progressive, unrecoverable neurological complaint with enervating symptoms that can make diurnal life challenging,” said Michael Severino,M.D., vice president and chairman, AbbVie.”We are committed to addressing the continued requirements of cases and are encouraged by these results that punctuate a implicit indispensable treatment option for those affected by advanced Parkinson’s complaint.”
” Cases need further remedial options to control their symptoms and worrisome dyskinesia for this enervating complaint,” said Jason Aldred,M.D. FAAN of Selkirk Neurology, clinical associate professor at the University of Washington, clinical adjunct professor at Washington State University ElsonS. Floyd College of Medicine, and a top investigator of the study.”These data are promising and demonstrate positive results on a crucial endpoint used to assess efficacity of treatments for cases with advanced Parkinson’s.”

Full results from the Phase 3 study will be presented at a unborn medical meeting or submitted for publication in a peer- reviewed journal. ABBV-951 is an investigational remedy and it isn’t approved for use. The safety and efficacity of ABBV-951 haven’t been estimated by nonsupervisory authorities.
About the Phase 3 M15-736 Study2
The Phase 3 randomized, double-eyeless, double- dummy, active-controlled study compared the efficacity, safety and tolerability of ABBV-951 (foslevodopa/ foscarbidopa) to oral LD/ CD in advanced PD cases. Parkinson’s complaint cases were handed with a home journal (the PD Diary) to assess their motor status. The primary endpoint of” good” time ( defined as”On” time without dyskinesia plus”On” time withnon-troublesome dyskinesia), in discrepancy to” bad” time (“Off” time plus”On” time with worrisome dyskinesia) is collected and equaled over three successive days and regularized to a typical 16-hour waking period. Birth values are defined as the normal of regularized” good” time collected over the three PD Diary days before randomization. Roughly 130 adult actors with advanced PD were enrolled in the study across 80 spots worldwide. The study was comprised of two arms. In one arm, actors entered the ABBV-951 result as a nonstop infusion under the skin plus oral placebo capsules for levodopa/ carbidopa. In the alternate arm, actors entered placebo result for ABBV-951 as a nonstop subcutaneous infusion plus oral capsules containing levodopa/ carbidopa reprised tablets. The treatment duration was 12 weeks. Further information on the study can be plant onwww.clinicaltrials.gov (NCT04380142).

About ABBV-951
ABBV-951 (foslevodopa/ foscarbidopa) is a result of levodopa and carbidopa prodrugs for nonstop subcutaneous infusion that’s being delved for the treatment of advanced Parkinson’s complaint in cases whose motor symptoms aren’t controlled by oral specifics.

About Parkinson’s Disease
Further than 10 million people worldwide are living with Parkinson’s complaint, a progressive and habitual neurological complaint characterized by earthquake, muscle severity, slowness of movement, and difficulty with balance.4 The motor symptoms of Parkinson’s complaint affect from the loss of dopamine- producing brain cells and begin when roughly 60-80 percent of these cells are lost.4 Symptoms continue to worsen sluggishly over the course of time.5 While there’s no given cure for the complaint, there are treatments available to help reduce symptoms.6

As Parkinson’s complaint progresses, cases can witness oscillations from an”On” state (when symptoms are generally well controlled) to an”Off” state, during which earthquake and stiffness reappear and cases have further difficulty in moving.7 Cases can also witness dyskinesia ( involuntary movements) which can significantly hamper diurnal conditioning.7 Disease progression and shifting levodopa situations are responsible for the onset of motor complications, including oscillations and dyskinesia, with 50 percent of cases reporting them two to five times after inauguration of treatment and roughly 80-100 percent of cases presenting with them after ten times.8

About AbbVie
AbbVie’s charge is to discover and deliver innovative drugs that break serious health issues moment and address the medical challenges of hereafter. We strive to have a remarkable impact on people’s lives across several crucial remedial areas immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.

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