Clinical trial design1

OPEN-LABEL TITRATION PHASE

DOUBLE-BLIND MAINTENANCE PHASE

The KYNMOBI clinical trial included a titration phase and a 12‐week, double‐blind maintenance phase. Patients were titrated to the dose that achieved a full ON response within 45 minutes. Then, patients were randomized 1:1 to either KYNMOBI at the tolerated dose that achieved full ON during the titration phase or matching placebo.

In the open-label titration phase, patients received increasing doses from 10 mg to 35 mg in 5-mg increments until they achieved a Full ON within 45 minutes

Patients completed home-dosing and response diaries 2 days prior to their Week 12 visit

Patients could self-administer study medication up to 5 times per day, 2 hours apart at home when needed

The KYNMOBI clinical trial included a titration phase and a 12‐week, double‐blind maintenance phase. Patients were titrated to the dose that achieved a Full ON response within 45 minutes. Then, patients were randomized 1:1 to either KYNMOBI at the tolerated dose that achieved full ON during the titration phase or matching placebo.

In the open-label titration phase, patients received increasing doses from 10 mg to 35 mg in 5-mg increments until they achieved a Full ON within 45 minutes

Patients completed home-dosing and response diaries 2 days prior to their Week 12 visit

Patients could self-administer study medication up to 5 times per day, 2 hours apart at home when needed

Mean change from predose to 30 minutes postdose in Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III (motor examination) score at Week 12.2

  • Had a response comparable to, or better than, their normal response to Parkinson's disease (PD) medications (eg, oral levodopa)
  • Felt a benefit in regard to mobility, stiffness, and slowness
  • Felt capable of performing normal daily activities

When Your Patients Experience Off Episodes, Help Them Get Back On2

Significant improvement in OFF symptoms was demonstrated at 30 minutes at Week 12 (P=0.0002) (primary endpoint)1,2

Efficacy Chart
Efficacy Chart

Within 30 minutes:

  • 2x as many patients receiving KYNMOBI rated themselves as having a Full ON compared with placebo (35% vs 16%; P=0.043) (key secondary endpoint)3
  • 79% of KYNMOBI-treated OFF episodes resulted in a self-rated Full ON compared to 31% with placebo, as demonstrated in home-dosing and response diary data over 2 days (secondary endpoint)3*

*This diary recorded the time of each dose and whether a Full ON was achieved at 30 minutes postdose. This secondary endpoint did not demonstrate statistical significance.3

LS=least squares; MDS-UPDRS=Movement Disorder Society-Unified Parkinson's Disease Rating Scale; SE=standard error.

Improvement In OFF Symptoms

Improvement in MDS-UPDRS Part III scores was reported as soon as 15 minutes after taking KYNMOBI and continued to be observed at 90 minutes1,2


References: 1.Data on file. Sunovion Pharmaceuticals Inc. 2. Kynmobi. Prescribing information. Sunovion Pharmaceuticals Inc; May 2020. 3. Olanow CW, Factor SA, Espay AJ, et al; for the CTH-300 Study Investigators. Apomorphine sublingual film for off episodes in Parkinson’s disease: a randomised, double-blind, placebo-controlled phase 3 study. Lancet Neurol. 2020;19[2]:135-144. 4. Goetz CG, Tilley BC, Shaftman SR, et al. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov Disord. 2008;23(15):2129-2170.

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