The New Drug Application (NDA) for SPN-830 (apomorphine infusion pump; Supernus Pharmaceuticals) has been submitted to the Food and Drug Administration (FDA) for the continuous treatment of on-off episodes in adults with Parkinson disease (PD) whose motor control is unsatisfactory with oral levodopa and at least 1 other noninvasive PD therapy.
Apomorphine, a non-ergoline dopamine agonist, is believed to treat off episodes associated with PD through stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain. SPN-830 provides a continuous subcutaneous infusion of apomorphine through an infusion pump. The NDA for SPN-830 is supported by data from an extensive development program that includes the phase 3 TOLEDO study and a supportive open-label study.
TOLEDO was a multicenter, double-blind, placebo-controlled trial that assessed the efficacy and safety of SPN-830 in 106 adults with PD whose motor fluctuations were not adequately controlled on optimized treatment. Patients were randomized to receive SPN-830 or placebo during waking hours for 12 weeks. The primary end point was the change from baseline to week 12 in mean daily off time over 24 hours based on patient diaries.
Results from TOLEDO demonstrated that SPN-830 was associated with a statistically significant reduction in mean daily off time of 2.47 hours compared with 0.58 hours for placebo (difference -1.89 hours per day; 95% CI: -3.16, -0.62; P =.0025).
In the open-label study, the safety, efficacy and tolerability of SPN-830 was investigated in 94 PD patients. Findings showed mean daily off time decreased from baseline to week 12 by 3 hours (P <.0001).
As for safety, the most common treatment-related adverse events were infusion site reactions, nausea, and dyskinesia; most of the adverse events were mild or moderate in severity.
“Current alternatives to acute treatment often require continuous infusion of levodopa through a gastric tube or surgical intervention such as deep brain stimulation,” said Jack Khattar, President and CEO of Supernus. “SPN-830, if approved by the FDA, would offer patients a less invasive and a convenient option in the form of a continuous subcutaneous infusion of apomorphine.”
For more information visit supernus.com.
- Supernus submits NDA for SPN-830 for continuous treatment of ON-OFF episodes in adults with Parkinson’s disease who have failed two treatments. https://www.globenewswire.com/news-release/2020/09/14/2092953/0/en/Supernus-Submits-NDA-for-SPN-830-for-Continuous-Treatment-of-ON-OFF-Episodes-in-Adults-with-Parkinson-s-Disease-Who-Have-Failed-Two-Treatments.html. Accessed September 15, 2020.
- Katzenschlager R, Poewe W, Rascol O, et al. Apomorphine subcutaneous infusion in patients with Parkinson’s disease with persistent motor fluctuations (TOLEDO): a multicentre, double-blind, randomised, placebo-controlled trial. The Lancet. Published online September 1, 2018. doi: 10.1016/S1474-4422(18)30239-4.