Proven efficacy Help patients GO ON with less daily OFF time and more GOOD ON time1
Proven results
Significant reduction in daily OFF time accompanied by a similar significant increase in GOOD ON time* at 12 weeks1
LESS OFF TIME1
(primary endpoint)
-2.6 h/day
-0.9 h/day placebo(P=0.0114)
MORE GOOD ON TIME*1
(key secondary endpoint)
+2.8 h/day
+1.1 h/day placebo (P=0.0188)
Placebo was a saline solution infusion.
*ON time without troublesome dyskinesia.
MEAN CHANGE FROM BASELINE IN DAILY OFF TIME AND GOOD ON TIME†1,2
†OFF time (LS mean change ± SE): ONAPGO, -2.6 ± 0.5; placebo, -0.9 ± 0.4; GOOD ON time (mean ± SE): ONAPGO, +2.8 ± 0.5; placebo, +1.1 ± 0.5.1
PATIENT IMPACT (PGI-C)1,2
(key secondary endpoint)
79%
of patients treated with ONAPGO reported improvements in general health state at week 12
vs 24% of placebo-treated patients(P<0.0001)
MEDICATION REDUCTION2
vs 5% placebo at week 12 (other secondary endpoint)
‡Post-hoc analysis results should be interpreted with caution since findings are not pre-specified and may be exploratory in nature, without adjustment for multiple comparisons. Data are descriptive and conclusions cannot be drawn.
In ONAPGO clinical studies, patients were able to reduce or discontinue concomitant medications.§ Dose reductions were made in the following order2:
Dopamine Agonists (oral or transdermal)
MAO-B Inhibitors
COMT Inhibitors
Levodopa
§All patients treated with ONAPGO in the double-blind study were maintained on levodopa.1
STUDY DESIGN
The multicenter, parallel-group, double-blind, randomized, placebo-controlled study evaluated the efficacy and safety of ONAPGO subcutaneous infusion in 107 patients with PD who had motor fluctuations averaging ≥3 hours per day while receiving carbidopa/levodopa and other concomitant PD medications. The study included a double-blind, 12-week treatment period, inclusive of 1-4 weeks of dose titration with continued treatment with study medication at an individualized, stable dosage. The primary efficacy endpoint was change in total daily OFF time assessed from baseline to the end of the 12-week treatment period based on patient diaries. A key secondary endpoint was change in daily ON time without troublesome dyskinesia from baseline to the end of the 12-week treatment period and PGI-C. Other secondary endpoints were mean changes in oral levodopa dose and LED at week 12.
Abbreviations: COMT=catechol-O-methyltransferase; LD=levodopa; LS=least squares; MAO-B=monoamine oxidase B; PD=Parkinson's disease;
PGI-C=Patient Global Impression of Change; SE=standard error.
SAFETY1
ADVERSE REACTIONS REPORTED BY ≥5% OF PATIENTS RECEIVING ONAPGO AND HIGHER THAN PLACEBO IN STUDY 1 DURING THE 12-WEEK TREATMENT PERIOD1
| ADVERSE REACTIONS | ONAPGO‡ n=54 | Placebo n=53 |
| Infusion site nodule | 44% | 0% |
| Nausea | 22% | 9% |
| Somnolence | 22% | 4% |
| Infusion site erythema | 17% | 4% |
| Dyskinesia | 15% | 0% |
| Headache | 13% | 4% |
| Insomnia | 11% | 2% |
| Dizziness | 9% | 4% |
| Hypotension | 7% | 0% |
| Asthenia | 7% | 0% |
| Fatigue | 7% | 2% |
| Constipation | 7% | 6% |
| Vomiting | 7% | 4% |
‡Variable doses.
Infusion site nodule formation and erythema were generally mild to moderate5
Rate of hallucinations: 4% ONAPGO vs 4% placebo1
In the pivotal trial, 6 (11%) patients receiving ONAPGO vs 0 patients receiving placebo discontinued due to ARs:
- 1 patient discontinued for each of the following: nausea, orthostatic intolerance, visual hallucination, gait disturbance, infusion site nodule, and hypotension1
- No consistent pattern of ARs or dose relationship for study discontinuation found2
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