Sponsored by Sunovion Pharmaceuticals Inc.
The chronic and progressive nature of Parkinson’s disease (PD) can be challenging as we work to manage the condition and identify an appropriate balance of treatments for patients.
Carbidopa/levodopa has long been the gold standard for the treatment of PD. Carbidopa/levodopa is usually the first prescription we, as healthcare providers, recommend when a patient is diagnosed with PD and requires symptomatic benefit. Additional therapies, including but not limited to, MAO-B or COMT inhibitors and dopamine agonists may be added to a patient’s treatment plan as needed to help manage progressive PD symptoms.
Unfortunately, as the condition progresses, an individual’s response to carbidopa/levodopa may become erratic and less consistent, leading to the re-emergence or worsening of PD symptoms otherwise controlled with carbidopa/levodopa—also known as OFF episodes.
Over time, the therapeutic window narrows and an individual’s response to carbidopa/levodopa becomes progressively less consistent. After five years of treatment with levodopa, as many as 50% of people with PD experience OFF episodes; this percentage increases to 70% of people after nine years of taking oral carbidopa/levodopa.1,2
Characterized in part by motor symptoms like tremor, rigidity, bradykinesia, or other symptoms, OFF episodes can present in the morning upon awakening, and may happen multiple times throughout the day.3
These OFF episodes can be disruptive for patients and their care partners. During an OFF episode, doing activities like getting out of bed or up from a chair, walking unassisted, buttoning a shirt, or eating may be nearly impossible for a patient to accomplish on their own. Despite the addition of daily adjunctive treatments to help address OFF episodes, people can still spend hours each day navigating these challenges while trying to maintain their routines.
With an evolving treatment landscape, there are on-demand options to treat OFF episodes as they occur, including a novel sublingual therapy. KYNMOBI® (apomorphine HCl) sublingual film is approved by the U.S. Food and Drug Administration (FDA) for the acute, intermittent treatment of OFF episodes associated with PD. This film formulation of apomorphine dissolves under the tongue to treat OFF episodes on-demand. The discreet delivery method allows for the absorption of apomorphine through the oral mucosa.
In clinical trials, treatment with KYNMOBI resulted in statistically significant improvement in motor symptoms associated with OFF episodes at 30 minutes after dosing, compared to placebo. Improved scores in motor symptoms were seen as early as 15 minutes post-administration and persisted up to 90 minutes. A recently shared pooled analysis of the pivotal and ongoing long-term safety study (open-label dose titration phases) of KYNMOBI compared motor improvement after treatment with KYNMOBI vs. levodopa and the mean motor response with KYNMOBI was shown to be approximately two times higher at 15 minutes post-dose and remained higher at 30 minutes post-dose.4
For these reasons, I consider KYNMOBI an important therapeutic option. My patients appreciate having an on-demand solution to treat OFF episodes as they occur that they can easily carry with them. It affords them greater control of their PD symptoms throughout the day and helps them to navigate their lives more easily between carbidopa/levodopa doses.
Patients and care partners might notice that, over time, the response to oral carbidopa/levodopa has become less consistent. Some people may not recognize the patterns in these changes or know how to articulate the experience, and others may also adapt their activities and routines to accommodate their OFF episodes.
As healthcare providers, we can help patients and their care partners identify the patterns in OFF episodes and work with them to proactively address the challenges they face as their disease progresses.
Probing deeper about bothersome symptoms and encouraging people to monitor the times of day they experience more PD symptoms as well as tracking challenges in navigating activities are important areas of discussion for our patients and their care partners.
To learn more about PD OFF episodes and the potential for treatment with KYNMOBI, visit KYNMOBIHCP.com. Please see below for Important Safety Information.
IMPORTANT SAFETY INFORMATION AND INDICATION FOR KYNMOBI (apomorphine hydrochloride) SUBLINGUAL FILM
Contraindications: KYNMOBI is contraindicated in patients:
Warnings and Precautions:
Most Common Adverse Reactions: Most common adverse reactions (incidence at least 10% in patients treated with KYNMOBI and with an incidence greater than placebo) were nausea, oral/pharyngeal soft tissue swelling, oral/pharyngeal soft tissue pain and paraesthesia, dizziness, and somnolence.
KYNMOBI (apomorphine hydrochloride) sublingual film is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.