EMBARGOED until DAY, June 22, 2018
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MIAMI – Sublingual apomorphine film (APL-130277) offers an effective and well-tolerated treatment for managing OFF episodes in Parkinson’s disease (PD), according to a study released today at the 2nd Pan American Parkinson’s Disease and Movement Disorders Congress.
Levodopa is an effective treatment for PD motor symptoms, but often requires dosing multiple times per day. However, patients frequently experience a fluctuating response, ON (levodopa-induced mobility) and OFF (no levodopa effect) periods because of unpredictable absorption of levodopa. An apomorphine film administered under the tongue, APL-130277 (APL), was developed and evaluated as an acute therapy to reverse OFF periods. The study enrolled patients experiencing a mean of 3.9 OFF periods per day, and 109 were randomized to receive APL or placebo up to five times per day for 12 weeks. Results were based on MDS-UPDRS III scores and patient-determined FULL ON response at 30 minutes post-dose after 12 weeks. After the 12 week maintenance phase, MDS-UPDRS III scores improved and there was a significant difference favoring APL over placebo in the percentage of patients who rated themselves as FULL ON at 30 minutes, as well as the percentage of patients ON within 30 minutes who remained on for at least 30 minutes. Additionally, home dosing diaries showed a larger percentage of APL patients turned ON within 30 minutes post-dose compared to placebo.
John Nutt, Professor of Neurology at Oregon Health & Science University states, “This abstract is important to highlight as a new therapy, because many PD patients are treated with levodopa, but experience OFF periods throughout the day. These OFF periods can be painful and frustrating for patients, who need to regain mobility before the next oral dose of levodopa takes effect. Apomorphine administered subcutaneously has previously been used to treat these OFF periods, but patients often are not receptive to needles. Something administered under the tongue is much more appealing and would be a valuable rescue therapy, as nothing at this point is marketed to treat OFF periods.”
B. Navia, S. Factor, R. Pahwa, R. Hauser, M. Worden, P. Bhargava, G. Vakili, D. Blum. (2018). 2nd Pan American Parkinson's Disease and Movement Disorders Congress. Late-Breaking Abstracts, Efficacy and Safety of Sublingual Apomorphine film (APL-130277) for the Treatment of OFF Episodes in Patients with Parkinson's Disease: Results from a Double-Blind, Placebo-Controlled Trial, p. 3. Reference Late-Breaking Abstracts
About the 2nd Pan American Parkinson’s Disease and Movement Disorders Congress:
Meeting attendees gather to learn about the latest research findings and relevant issues in the field of Movement Disorders specific to North, Central and South America. Over 600 physicians and medical professionals will be able to view over 250 scientific abstracts submitted by clinicians from the Pan American region and throughout the world.
About the International Parkinson and Movement Disorder Society:
The International Parkinson and Movement Disorder Society (MDS), an international society of over 7,000 clinicians, scientists, and other healthcare professionals, is dedicated to improving patient care through education and research. For more information about MDS, visit www.movementdisorders.org.