Company: SUPN
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0001356576-25-000017
Chunk: 154

Company: SUPERNUS PHARMACEUTICALS, INC.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 154
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, stiffness, loss of balance, and lack of coordination. PD is the second most common progressive neurodegenerative disorder, affecting 1-2% of individuals 65 years and older. Patients with PD can also be affected with psychological symptoms such as anxiety, depression, aggression, and problems with cognition and memory. As the disease progresses, some patients may lose the ability to independently perform the tasks of daily living. 

The most commonly prescribed medicine for PD is levodopa. PD patients are frequently prescribed levodopa to help replace dopamine, which is reduced in the brain. However, motor disabilities as a result of levodopa wearing off remain a significant problem for over half of PD patients. Patients in an "OFF" state, including those whose last dose of oral levodopa has worn off and whose next oral dose has not yet begun to take effect, can suffer from reduced coordination or mobility for several hours per day. Carbidopa may be used along with levodopa to improve its efficacy and reduce the amount of levodopa needed to control PD symptoms. There are a number of alternative adjunctive treatment options (FDA-approved and in clinical development) for Parkinson's patients, including various levodopa preparations, dopamine agonists, MAO-B inhibitors, and others. 

APOKYN is given as needed as an adjunct to levodopa/carbidopa therapy in PD patients who experience "OFF" episodes. In well-controlled clinical studies, APOKYN injections were effective in treating "OFF" periods, as measured by the motor function subset of the Unified Parkinson's Disease Rating Scale (UPDRS). APOKYN, delivered via an injection pen, is for patients for whom oral levodopa will not sufficiently control "OFF" periods. Patients taking APOKYN saw 95% of "OFF" episodes reversed, with improvement beginning as quickly as 10 minutes post-dosing in clinical studies. With the alternative of immobility and limited function, we believe the rapid and reliable reduction of "OFF" episode symptoms is of utmost importance to patients. APOKYN competes with pro re nata therapies such as Inbrija, and other adjunctive therapies, including NOURIANZ. APOKYN also competes with other products for the treatment of PD, both branded such as VYALEV, and generic, including levodopa products.

For patients who experience significant "OFF" time each day, the Company has developed ONAPGO, formerly known as SPN-