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Sunovion announced that Health Canada has accepted the New Drug Submission (NDS) for apomorphine sublingual film (APL-130277) to treat motor fluctuations (OFF episodes), experienced by people living with Parkinson’s disease (PD), including those who experience early morning OFF episodes.

OFF episodes can cause severe disruption for someone living with PD, often causing a major disturbance in a person’s ability to maintain everyday activities. While OFF episodes are experienced by 40 to 60 percent of all people living with PD, there are limited on-demand treatment options available.1

“Few options are available for the treatment of motor fluctuations which are commonly experienced by patients with Parkinson’s disease,” said Antony Loebel, M.D., executive vice president and CMO at Sunovion, head of global clinical development for Sumitomo Dainippon Pharma Group. “We look forward to working with Health Canada to bring apomorphine sublingual film to patients with OFF episodes and Parkinson’s disease in Canada.”

Apomorphine sublingual film is being developed as a fast-acting medicine for the on-demand treatment of all types of OFF episodes, including morning OFF, unpredictable OFF, and end-of-dose wearing OFF.

About Apomorphine Sublingual Film (APL-130277)

Apomorphine sublingual film (APL-130277), a novel formulation of apomorphine, a non-ergot dopamine agonist, is being developed as a fast-acting sublingual film for the on-demand management of OFF episodes associated with Parkinson’s disease (PD). Apomorphine is the only agent approved for the acute, intermittent treatment of hypomobility, “OFF” episodes (“end-of-dose wearing OFF” and unpredictable “ON/OFF” episodes) associated with advanced PD, and in Canada and the U.S. it is currently approved as a subcutaneous injection. Apomorphine sublingual film is intended to rapidly convert people living with PD from an OFF to an ON state and has been studied for the treatment of OFF episodes up to five times per day.

Sunovion announced the U.S. Food and Drug Administration accepted its New Drug Application submission for apomorphine sublingual film on June 12, 2018. Apomorphine sublingual film has not been approved by Health Canada. In October 2016, Sunovion acquired Cynapsus Therapeutics Inc. (Canadian Specialty Central Nervous System Biotechnology Company), along with its product candidate APL-130277. The Michael J. Fox Foundation for Parkinson’s Research funded in part two Phase I trials of APL-130277–a comparative biostudy in healthy volunteersand a dosing study in people with Parkinson's disease.

References

1 Schrag, A. “Dyskinesias and motor fluctuations in Parkinson's disease: A community-based study.” Brain. November 2000, Vol. 123, Issue 11. p. 2297-2305. Available online: https://academic.oup.com/brain/article/123/11/2297/256050. Accessed March 2018.

(Source: Sunovion Pharmaceuticals Inc.)

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