The Food and Drug Administration has approved a new drug to treat Parkinson’s patients who develop periods of immobility.
The problem, called hypomobility or “off-periods,” affects about 10 percent of people with Parkinson’s disease, the agency said Wednesday.
The drug, apomorphine, to be sold under the name Apokyn, was given priority as an orphan drug. It is the first drug to treat these episodes, which affect about 112,000 people, the agency said.
The FDA said that within 3 years to 5 years of treatment with standard Parkinson’s drugs, about 10 percent of patients develop these episodes, when they are unable to rise from a chair, to speak or to walk. The episodes can occur toward the end of a dosing interval with standard medications or at unpredictable times.
Apokyn, which is injected, can cause severe nausea and must be taken with an anti-nausea drug. Certain anti-nausea drugs, such as ondansetron, must be avoided because the combination can lead to very low blood pressure and loss of consciousness.
Apokyn is manufactured for Bertek Pharmaceuticals of Research Triangle Park, N.C., by Draxis Pharma Inc. of Canada.
ncG1vNJzZmivp6x7r67Cp5ywq16YvK57x56YpayYZLWmrcutn2amlazAcLLDmmSaqKCnvLex0malnq9dpa6zt8inqqimo2Kxs8HGZp2lppFmsHqAk21vaWg%3D