Cynapsus Therapeutics Announces No Buccal Mucosal Irritation In FDA Registration Study Of APL-130277 For Parkinson’s Disease
5/14/2014 11:55:20 AM
Cynapsus Announces No Buccal Mucosal Irritation In FDA Registration Study Of APL-130277 For Parkinson’s Disease
TORONTO, CANADA – (Marketwired) – Cynapsus Therapeutics Inc. (CTH: TSX-V) (CYNAF: OTCQX), a specialty pharmaceutical company, today announced no irritation was observed when testing the APL-130277 sublingual apomorphine formulation in a buccal mucosal irritation model in hamsters, either macroscopically (clinician observation of oral cavity) or microscopically. The study was conducted in compliance with the Good Laboratory Practice for Nonclinical Laboratory Studies of the United States Food and Drug Administration (“FDA”), 21 CFR Part 58, and OECD Principles of Good Laboratory Practice (OECD, 1998).
APL-130277 is an easy-to-administer, fast-acting and proprietary reformulation of apomorphine for sublingual delivery. Injectable apomorphine is the only approved drug in the United States, Europe, Japan and other countries for the acute rescue of “off” motor symptoms of Parkinson’s disease. The APL-130277 thin film strip system technology is specifically designed to provide enhanced convenience and eliminate buccal mucosal irritation, among other attributes.
Mr. Anthony Giovinazzo, President and CEO of Cynapsus commented: “The data, coupled with our clinical results to date, continues to validate the design of our thin-film strip technology. Since we started the development of APL-130277, we have been aware of the possibility of buccal mucosa irritation with extended use, so we determined it was prudent to complete this irritation study sooner rather than later. This study is also a required registration study by the FDA. We are encouraged with the results, and look forward to demonstrating similar results in upcoming human clinical trials planned over the next 24 months. This study provides evidence that APL-130277 may provide therapeutic levels of apomorphine dosing with low or no irritation when used by Parkinson’s patients multiple times per day on a daily basis.”
The APL-130277 strips have also been administered in approximately 100 healthy human volunteers in single dose studies, with no evidence of irritation.
About The Buccal Mucosal Irritation Model
In the study, three times each day for 28 consecutive days, an equal number of placebo and apomorphine containing thin strips were placed in the cheek of the animals. The dose used in the study was significantly higher, on a relative weight adjusted basis, than what would normally be given to patients. Care was taken to apply the thin strips to the same region of each cheek pouch for every dose application.
There was no external evidence of irritation based on clinical evaluations of the cheek pouches during the study and at the end of the 28 days of dosing.
In microscopic analysis there was no observed evidence of irritation or inflammation.
Apomorphine, a potent dopamine agonist, is the only drug approved specifically for the treatment of acute motor fluctuations/hypomobility (freezing or “off” episodes) in patients with advanced Parkinson's disease. Presently, apomorphine is administered by intermittent subcutaneous injection usually via a pre-filled injection pen, or, in some cases outside the United States, by continuous infusion pump. Drawbacks associated with subcutaneous injection therapy for patients and caregivers include aversion to needles, the need for multiple injections, which can be painful and are often associated with irritation and inflammation at the injection site, and the requirement for a degree of manual dexterity that some Parkinson’s patients find difficult.
About Cynapsus Therapeutics
Cynapsus is a specialty pharmaceutical company developing a convenient and easy to use sublingual (oral) thin film strip for the acute rescue of “off” motor symptoms of Parkinson’s disease. Cynapsus’ drug candidate, APL-130277, is an easy-to-administer, fast-acting reformulation of apomorphine, which is the only approved drug (in the United States, Europe, Japan and other countries) to rescue patients from “off” episodes. Cynapsus is focused on maximizing the value of APL-130277 by completing pivotal studies in advance of a New Drug Application (“NDA”) expected to be submitted in 2016.
Over one million people in the U.S. and an estimated 4 to 6 million people globally suffer from Parkinson's disease. Parkinson’s disease is a chronic and progressive neurodegenerative disease that impacts motor activity, and its prevalence is increasing with the aging of the population. Based on a recent study and the results of the Corporation’s Global 500 Neurologists Survey, it is estimated that between 25 percent and 50 percent of patients experience “off” episodes in which they have impaired movement or speaking capabilities. Current medications only control the disease’s symptoms, and most drugs become less effective over time as the disease progresses.
More information about Cynapsus (TSX-V: CTH) (OTCQX: CYNAF) is available at www.cynapsus.ca and at the System for Electronic Document Analysis and Retrieval (SEDAR) at www.sedar.com.
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