Q: I heard that a new under the tongue add-on treatment was approved for Parkinson’s disease (PD). What can you tell me about it?
A: The U.S. Food and Drug Administration (FDA) recently approved Kynmobi (apomorphine sublingual film) for the on-demand intermittent treatment of “OFF” episodes in patients with PD.
An “OFF” episode is a time when a patient’s medications are not working well, causing an increase in PD symptoms, such as tremor, muscle rigidity and stiffness, slowness of movement, or impaired balance and coordination.
Significant “OFF” episodes can be experienced by up to 60% of PD patients. According to the National Institutes of Health, PD is the second-most common neurodegenerative disorder in the U.S. after Alzheimer’s disease.
An estimated 50,000 Americans are diagnosed with PD each year and about 1 million Americans have the condition. This neurological disorder typically occurs in people older than age 60, although it can occur earlier.
It develops when cells in the brain, which produce a chemical called dopamine, become impaired or die. Dopamine helps transmit signals between the areas of the brain that produce smooth, purposeful movements.
Apomorphine (Apokyn) injection has been available for many years, but Kynmobi is the first and only sublingual (under the tongue dissolvable thin film formulation) apomorphine product to be approved. Apomorphine is known as a “dopamine agonist” which “mimics” the therapeutic action of dopamine in the brain.
The approval of Kynmobi was primarily based upon a clinical trial involving 109 patients who had PD for an average of nine years and were experiencing an average number of four “OFF” episodes daily while receiving levodopa treatment by itself or in conjunction with other commonly used PD medications.
Results from this study showed that patients receiving sublingual Kynmobi had significant improvements in movement (motor ) symptoms 30 minutes after dosing, compared to patients taking a sublingual placebo (“dummy”) film.
The most common sides effects of Kynmobi in this study were nausea, swelling and pain/tingling/sores in the mouth and tongue, dizziness and sleepiness. Other side effects and drug interactions can occur with Kynmobi and should be discussed with the prescriber and pharmacist.
Kynmobi can be taken up to five times daily as needed, with doses separated by at least two hours. Dose determination and initiation should be supervised by a health care provider. Treatment with an anti-nausea and vomiting agent like trimethobenzamide (Tigan) is also recommended, beginning three days prior to the first dose of Kynmobi.
Kynmobi is scheduled to be available in September 2020. More detailed information about this new product can be found at www.kynmobi.com.
Richard P. Hoffmann, Pharm.D, is a retired pharmacist and medical writer with over 40 years of experience. He currently serves as acting consumer representative on the FDA’s Advisory Committee for Peripheral and Central Nervous System Drugs, and is a patient representative for FDA Advisory Committees related to Parkinson’s disease. Dr. Hoffmann is also a research advocate for the Parkinson’s Foundation.