The Food and Drug Administration (FDA) has approved Kynmobi™ (apomorphine hydrochloride; Sunovion) for the acute, intermittent treatment of off episodes in patients with Parkinson disease (PD).
Kynmobi is a sublingual film formulation of apomorphine, a non-ergoline dopamine agonist. Apomorphine is believed to treat off episodes associated with PD through stimulation of postsynaptic dopamine D2-type receptors within the caudate-putamen in the brain. The product was designed for use as a fast-acting, on-demand treatment for all types of motor off episodes.
The approval was based on data from a double-blind, placebo-controlled, parallel-group study that included patients with a mean PD duration of approximately 9 years who were Hoehn and Yahr Stage III or less in the on state, and who were receiving concomitant levodopa with a stable dose for at least 4 weeks before screening. At baseline, all patients had a similar number of daily off episodes.
Following a titration phase, patients were randomized to either Kynmobi (n=54) or placebo (n=55), which was used to treat up to 5 off episodes per day. The primary end point of the study was the mean change from predose to 30 minutes postdose in the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale, Part III (MDS-UPDRS III) at the 12-week visit of the maintenance phase.
Results showed that at Week 12, the Kynmobi treatment group showed a least-square mean improvement (ie, reduction in score) of -11.1 points (95% CI, -14.0, -8.2), vs -3.5 points for the placebo group (95% CI, -6.1, 0.9). The least-square mean treatment difference between Kynmobi and placebo was -7.6 (95% CI: -11.5, -3.7; P =.0002).
With regard to safety, the most common adverse reactions reported included nausea, oral/pharyngeal soft tissue swelling, oral/pharyngeal soft tissue pain and paraesthesia, dizziness, and somnolence. Because of the high incidence of nausea and vomiting, an antiemetic starting 3 days prior to the initial dose of Kynmobi is recommended. However, based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of this class of antiemetic agents (5HT3 antagonists), as well as alosetron, with apomorphine is contraindicated.
Kynmobi will be supplied as a sublingual film in 10mg, 15mg, 20mg, 25mg, and 30mg dosage strengths. Dose initiation should occur when the patient is in an off state and in a setting where a healthcare provider can monitor blood pressure and pulse.
The product is expected to be available in September 2020.
For more information visit kynmobi.com.