Following the recent news that Sunovion Pharmaceuticals has received Food and Drug Administration (FDA) approval for Kynmobi (apomorphine), a novel sublingual film for the acute treatment of OFF episodes in patients with Parkinson’s disease (PD);

Sarah Elsayed, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view on the opportunities and challenges in the market:

“Effective treatment for dyskinesia and OFF episodes remains an ongoing challenge in PD as, according to KOLs interviewed by GlobalData, over 60% of PD patients will eventually have OFF periods. These episodes are experienced by PD patients when levodopa, the standard of care (SOC) therapy, wears off resulting in worsening of PD symptoms such as rigidity and tremors.

“Kynmobi’s competitive advantage lies mainly on its novel formulation that allows patients to self-administer the drug on demand in a favorable route of administration (ROA) that readily dissolves under the tongue, improving initial symptoms as early as 15 minutes after administration. Currently the only apomorphine formulations used to manage patients with OFF episodes are either injection pens or infusion such as US WorldMeds’ Apokyn, however they require instruction on usage and variable dosing. Nevertheless, advancement in drug formulations is one of the most rapidly changing areas in PD and an example of that is Acorda with its inhaler Inbrija (levodopa). Sunovion’s Kynmobi tackles a key unmet need in the PD landscape due to its easy-to-use medication and its potential administration for a wider range of PD patients. The drug is expected to become a strong rival to Inbrija, which was approved in late 2018 in US.

“However, as a levodopa-based medication, Inbrija will likely offer superior control of motor symptoms when compared to apomorphine. This typically comes with a cost, as Inbrija’s common side effects include levodopa-induced dyskinesia and bronchospasm. On the other hand, apomorphine causes nausea and low blood pressure. Given that, the key differentiator among neurologists will be which drug has better tolerability in PD patients also which drug is more favorable to self-use during the OFF episode. GlobalData forecasts that Inbrija will generate $289m in the US by 2026 while Kynmobi will generate $219m over the same period.

“The simplicity and ease of use of Kynmobi will contribute to its uptake by prescribing physicians and also by patients, who may be averse to the self-injections required for the use of old formulations of apomorphine. GlobalData anticipates that Kynmobi will replace Apokyn pen as the rescue medication of choice for OFF episodes because of its improved formulation and it will show a moderate uptake upon launch.”