The FDA on Thursday approved a Sunovion Pharmaceuticals treatment for Parkinson’s disease, giving patients a new way to take an old drug.
The Sunovion product, Kynmobi, is a formulation of apomorphine hydrochloride, a drug that treats “off” episodes experienced by Parkinson’s patients. These are times when the standard of care drug, levodopa, wears off and tremors, stiffness, and other symptoms return. Apomorphine can be administered in several different ways. The Sunovion product is the first sublingual formulation of apomorphine approved by the FDA.
The FDA decision for Kynmobi comes 16 months after the FDA rejected Sunovion’s initial application. The Marlborough, MA-based company resubmitted the file last November with more details about the product’s packaging and additional analyses of clinical data.
Approval was based on the results of a a Phase 3, placebo-controlled study that enrolled 109 patients. The main goal was to show a change according a rating scale used to assess movement in Parkinson’s patients. According to results published in The Lancet, patients who received the Sunovion drug showed an average reduction of 7.6 points on the scale compared to the average reduction reported for patients given a placebo. The drug also took effect quickly, with initial improvements observed 15 minutes after the oral film was placed under patients’ tongues.
The Sunovion film was well tolerated by patients. The most frequent side effects reported in the study were nausea, reactions in the throat, drowsiness, and dizziness. The throat reactions prompted nine, or about 17 percent, of the 54 patients assigned to receive the drug—and one taking a placebo—to drop out of the study. The drug label warns that patients should not use Kynmobi if they are taking a class of drugs called 5HT3 antagonists to treat nausea. These drugs, in combination with apomorphine, can lead to low blood pressure and loss of consciousness.
Kynmobi is expected to compete against other products that also treat off episodes in Parkinson’s. Acorda Pharmaceuticals (NASDAQ: ACOR) markets Inbrija, an inhaled version of levodopa. US WorldMeds sells Apokyn, an injection pen that administers apomorphine. The company also sells a safinamide (Xadago) tablet to treat off episodes. Last month, Supernus Pharmaceuticals (NASDAQ: SUPN) announced it was acquiring the entire US WorldMeds central nervous system drug portfolio to add Parkinson’s disease products to its lineup.
Sunovion says it expects Kynmobi will be available in pharmacies in September.
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