Apomorphine sublingual film (Kynmobi, Sunovion Pharmaceuticals) was efficacious and generally safe and well tolerated for the on-demand treatment of OFF episodes in Parkinson’s disease, long-term follow-up of a phase 3 study has shown.
Besides the usual adverse effects with apomorphine, the sublingual film was associated with more oral adverse effects than seen with the injectable drug. However, it may have some advantages over subcutaneous apomorphine injections in terms of administration during OFF episodes.
The study was presented at the Movement Disorder Society 23rd International Congress of Parkinson’s Disease and Movement Disorders (Virtual) 2020.
For example, the new formulation is more convenient than carrying an injection. It comes in a small, tear-open packet that contains a medication strip the patient places under their tongue.
“When a patient is in the OFF state, depending on how OFF they are, they could have a little difficulty opening the strip [packet], but anyone can open the strip for them,” lead author Rajesh Pahwa, MD, professor of neurology and chief of the Parkinson and Movement Disorder Division at the University of Kansas Medical Center in Kansas City, Kansas, told Medscape Medical News. “On the other hand with the subcutaneous, they have to give the injection themselves and a stranger or someone is not going to help them with that.”
The aims of this open-label, 48-week follow-up were to add new patients to assess safety and tolerability over the long term and to see if continued benefit from a previous 12-week double-blind study was still present at 1 year for patients in the earlier study.
This multicenter study (NCT02542696) included “rollover” patients (n = 78 for safety; n = 70 for efficacy) from the previous phase 2/3 double-blind trial, as well as new patients with no prior exposure to apomorphine sublingual film (n = 347 for safety; n = 275 for efficacy).
New patients experienced one or more OFF episodes/day with a daily OFF time of ≥ 2 hours/day while on stable doses of levodopa-carbidopa. All had clinically meaningful responses to levodopa-carbidopa and were judged by the investigator to be Stage 1-3 by modified Hoehn and Yahr scale rating during ON periods.
Rollover patients completed the prior study and had no major changes in their anti-Parkinson’s medications since then. Mouth cankers or sores were exclusion criteria for either group. New subjects could not have received subcutaneous apomorphine within 7 days of a screening visit.
The demographics and baseline characteristics of the new and rollover groups were similar (approximately 64 years, 65%-71% male; 96% white, 8.3 to 9.6 years since diagnosis, 3.9 to 4.1 OFF episodes/day, and total mean daily levodopa dose of 1120 to 1478 mg).
Assessing only the group of new patients, the investigators reported that 80% had a Hoehn and Yahr score of 2 or 2.5 when in the ON state and a Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Part III pre-dose score of 41.8.
At the beginning of this study, patients in an OFF period received titrated doses of 10