The sublingual strip is intended to replace a painful subcutaneous injection that is currently the only available rescue therapy for these episodes. The Company recently reported positive results from a Phase I pharmacokinetic study.
Pivotal efficacy studies in apomorphine-naïve and apomorphine-experienced PD patients are expected to begin in the fourth quarter of 2014, followed by a safety study in 2015, leading to a potential regulatory filing in early 2016.
"The sublingual strip that Cynapsus is developing has the potential to substantially improve the treatment of ‘off’ episodes for Parkinson’s patients while also helping them avoid painful injections," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "Injection site reactions and the difficulty of self-administration have hampered subcutaneous apomorphine, and created an unmet medical need. The sublingual formulation has much greater potential to penetrate the market."
On January 13 Cynapsus reported positive results from a Phase I, CTH-103, comparing the pharmacokinetic profile of three doses of sublingual apomorphine to subcutaneous injections.
Results showed a stronger safety profile for APL-130277 as compared to subcutaneous injection, which should enable Cynapsus to pursue a differentiated label from injectable apomorphine with possibly better safety claims under 505(b)(2) regulatory approval.
In a 35 page Initiation Report by LifeSci Advisors, we explain the potential advantages of Cynapsus’ sublingual formulation of apomorphine over the subcutaneous injection and other products in development.
The report explores the scientific basis for using apomorphine to treat ‘off’ episodes in Parkinson’s disease patients. The addressable market is discussed, as well as the potential for APL-130277 to increase the number of patients using apomorphine to treat these episodes.
Dr. McDonald’s full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.