The Michael J. Fox Foundation for Parkinson's Research (MJFF) announces a milestone in the Foundation's impact on the Parkinson's disease (PD) therapeutic landscape. The U.S. Food and Drug Administration (FDA) approved Kynmobi from Sunovion Pharmaceuticals. This new therapy, which treats "off" time, when PD symptoms are not well controlled with oral medication, marks the second regulatory approval of a Parkinson's treatment funded by the Foundation.

"The remarkable momentum in Parkinson's research continues, and MJFF is proud to contribute to this success," said MJFF CEO Todd Sherer, PhD. "This approval brings an important new treatment option for people with Parkinson's who experience 'off.' We know from our research and discussions with the Parkinson's community that 'off' time can significantly disrupt daily life, which is why we funded early clinical development of Kynmobi."

The Foundation partially funded Phase I trials of Kynmobi — a thin-film formulation of apomorphine placed under the tongue — by biotechnology company Cynapsus Therapeutics in 2012 and 2014 with two grants totaling more than $1.4 million. This funding was made possible through a collaboration with MJFF's longtime supporter and partner the Edmond J. Safra Foundation. After multiple rounds of venture capital investment and a public offering, Sunovion acquired Cynapsus in 2016 and continued the development of Kynmobi.

The newly approved Kynmobi helps quickly alleviate "off" time when Parkinson's symptoms such as tremor or stiffness return between medication doses. These "off" periods can greatly impact quality of life, by limiting the ability to complete everyday tasks and adding uncertainty to a patient's day.

A 2014 MJFF survey of more than 3,000 people with Parkinson's disease found that more than 60 percent of respondents were in an "off" state for two or more hours per day and nearly 50 percent said their "off" time caused them to avoid or stop activities.

"We understand how profoundly disruptive these off periods are and are pleased to have developed a treatment that helps bring a person living with Parkinson's disease back on. We are grateful to The Michael J. Fox Foundation for its early support of Kynmobi and continued partnership in educating patients on the experience of 'off'," Sunovion Chief Executive Officer Antony Loebel, MD, said.