- A Parkinson's disease drug from Sunovion Pharmaceuticals Inc. hit the primary and key secondary endpoints of a Phase 3 study, lining it up nicely for an approval filing in the next few months.
- Data from the study showed Parkinson's patients who experienced "off" episodes had a significant reduction in motor fluctuations when treated with Sunovion's APL-130277, an under-the-tongue formulation of the dopamine agonist apomorphine, compared to placebo.
- Sunovion plans on submitting its drug to the Food and Drug Administration this spring. The company continues to analyze the latest results, and will present additional data at an upcoming scientific congress, according to a Monday statement.
Parkinson's disease treatments are on track to become a $5.7 billion opportunity for drugmakers by 2022, according to a recent report from research firm MarketsandMarkets. In light of the potential returns, many a biopharma have shelled out considerable money to develop such treatments.
Takeda Pharmaceutical Co. Ltd. in August agreed to pay as much as $400 million to get in on co-developing and commercializing AstraZeneca plc's early-stage alpha-synuclein antibody. Several months earlier, Neurocrine Biosciences Inc. handed over $30 million upfront to Portugal-based Bial for North American rights to Ongentys (opicapone), a drug already approved in Europe as an adjunct therapy for a specific subset of adults with Parkinson's.
In spite of the research, there remains a high level of unmet medical need among Parkinson's patients.
Between seven million and 10 million people around the world are living with the disease, yet many still rely on decades-old treatments like levodopa, which can lead to dyskinesia and "off" periods — instances where Parkison's symptoms are more pronounced, even though patients are taking their medication — after years of use.
"For people with Parkinson’s disease and their families, off episodes can have a significant emotional and practical impact, and there are currently few treatment options for these events," Antony Loebel, Sunovion's chief medical officer, said in the Jan. 29 statement.
As for Sunovion, the new Phase 3 data reinforce the notion its candidate could bring some diversification to the Parkinson's treatment landscape.
The trial enrolled 109 patients with Parkinson's who had experienced "off" episodes. Using Part III of the Movement Disorder Society Unified Parkinson's Disease Rating Scale, a measurement system for the motor symptoms associated with Parkinson's, investigators found those patients taking APL-130277 showed a 7.6 reduction in their average scores 30 minutes after administration, compared to placebo.
Sunovion reported that patients generally tolerated its drug well, with the most common treatment-emergent adverse events being nausea, drowsiness, dizziness, yawning and headache.
"Apomorphine is currently only available as an injection. If an alternative method to deliver the medicine were approved, such as apomorphine sublingual film, it would be an important new option for healthcare providers and people with Parkinson’s disease," said Stewart Factor, Director of the Movement Disorders Program at Emory University School of Medicine and the primary investigator on the Phase 3 study, in the statement.