Sunovion Pharmaceuticals gets USFDA nod for KYNMOBI for Parkinson's disease off episodes
KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed;
Marlborough: Sunovion Pharmaceuticals Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved KYNMOBI™ (apomorphine HCI) sublingual film (APL-130277) for the acute, intermittent treatment of OFF episodes in patients with Parkinson's disease (PD).
OFF episodes are the re-emergence or worsening of PD symptoms otherwise controlled with oral levodopa/carbidopa. They may be characterized, in part, by tremor, stiffness, slowed movement or other symptoms. These disruptive episodes can occur in the morning upon waking and throughout the day.
KYNMOBI dissolves under the tongue to help people with PD improve their OFF symptoms as needed.
"Today's approval of KYNMOBI advances treatment options for people with Parkinson's disease who experience OFF episodes and the associated disruption of everyday activities," said Antony Loebel, M.D., President and Chief Executive Officer at Sunovion. "We are pleased to offer the Parkinson's disease community a novel treatment option that we believe offers a convenient way for patients to rapidly improve impaired movements and better control their motor symptoms when they need it."
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