In a phase 3 study (NCT02605434), participants taking the “accordion pill,” (AP-CD/LD; Intec Pharma Ltd, Jerusalem, Israel), which releases carbidopa/levodopa gradually, had improvement in Parkinson’s disease (PD) symptoms. However, no significant difference in the duration of OFF time was seen compared to people receiving standard treatment with immediate release carbiodopa/levodopa.
The accordion pill formulation combines and loads drugs and active ingredients onto biodegradable films, folds the films, and places them inside a capsule for gradual release. It was hoped that more gradual release of carbidopa/levodopa might reduce the troublesome OFF periods that leave people with dyskinesia and other symptoms as they wait for a dose taken to effectively reach the central nervous system.
In this 13-week double-blind randomized study, 320 adults with PD were randomly assigned to receive AP-CD/LD or standard treatment. This assignment was made after a period during which each individual had dosage of each agent titrated to an effective dose. The primary efficacy endpoint was the change in the percent of daily OFF time during waking hours, based on Hauser home diaries.
“We are disappointed that the study didn’t meet its target endpoints with statistical significance,” said Jeffrey A. Meckler, vice chairman and chief executive officer, Intec Pharma. “While the data suggests that AP-CD/LD did achieve an acceptable safety profile and did treat PD symptoms, it did not achieve a statistically significant superiority to standard immediate release levodopa therapy. We are pleased with the good safety profile of the AP-CD/LD, as it demonstrates, for the first time, the long-term safety of the accordion pill, which is important for future potential applications and partnerships.”
Fabian H. Rossi, MD; Welwin Liu, MD; Lourdes Benes Lima, MD; Alvaro G. Estevez, PhD; Umesh Sharma, MD; Sujatha Vuyyuru, MD; Maria Clara Franco, PhD; and Nina Tsakadze, MD, PhD
Melissa Reider-Demer, DNP, MN, CNP; and Vishal Shah, MD
Elina Nikkola, PhD; and Vishal Shah, MD