Sunovion Seeks FDA Approval of Below-the-Tongue Apomorphine for Parkinson’s Off Periods

Sunovion Pharmaceuticals has asked the U.S. Food and Drug Administration to begin a regulatory review of its below-the-tongue formulation of apomorphine for Parkinson’s off periods.

The request is in the form of a New Drug Application for the formulation as a treatment for the periods when standard Parkinson’s drugs have worn off. Off periods are characterized by the return of both movement and non-movement symptoms. About half of patients taking the standard therapy levodopa have off episodes, which become more frequent and severe as the disease worsens.

Off periods can occur at any time, although they frequently happen right after a patient  awakens in the morning.

Sunovion refers to its therapy as apomorphine sublingual film (APL-130277). It is intended to kick in quickly, to reduce off periods. The company designed it to be taken up to five times a day.

Off periods, “which may be characterized by symptoms such as tremor, stiffness or slow movement, may disrupt the ability to perform everyday activities and may be burdensome for patients, families and caregivers,” Antony Loebel, the executive vice president and chief medical officer of Sunovion, said in a press release.

“We are pleased to have submitted the NDA [New Drug Application] for apomorphine sublingual film for the treatment of OFF episodes and look forward to working with the FDA during the review period,” said Loebel, who is also head of Global Clinical Development at Sunovion and its parent company, Sumitomo Dainippon Pharma.

Sunovion based the application largely on the results of a 12-week Phase 3 clinical trial (NCT02469090) that tested the therapy’s effectiveness and safety in Parkinson’s patients whose levodopa had worn off.

Researchers assessed the treatment’s effectiveness by looking at patients’ improvement in movement 30 minutes after dosing. The study also evaluated the percentage of patients who said they achieved a full response to the treatment within 30 minutes.

A key finding was that the therapy worked better than a placebo until 90 minutes after dosing. Patients also tolerated it well.

Sunovion will present the Phase 3 results at a future scientific conference.

The FDA had previously granted the treatment Fast Track Designation to accelerate its regulatory review.

The hallmark of Parkinson’s is loss of dopamine-producing nerve cells in the substantia nigra, an area of the brain that controls movement and coordination. Apomorphine has the same effect as dopamine, a neurotransmitter that facilitates communication between nerve cells.

Other formulations of apomorphine are the only approved treatments for Parkinson’s off episodes. It is available in the U.S. as an injection under the brand name Apokyn (US WorldMeds). However, this formulation can cause pain and injection-site reactions.