First-Of-Its-Kind Parkinson's Treatment OK'd
Apokyn Only Treatment for Sudden Attacks of Immobility
April 23, 2004 -- FDA has approved a first-of-its-kind treatment for Parkinson's disease. Apokyn helps relieve the sudden attacks of immobility that can leave Parkinson's patients unable to perform their regular daily activities.
These episodes can occur unexpectedly or as Parkinson's medication begins to wear off. When a person first starts to take their Parkinson's medications they are able to reduce symptoms throughout the day. However, a wearing off period develops when the medicine stops working, and their symptoms get worse. This is more commonly seen in people with advanced Parkinson's disease.
An estimated 1.5 million Americans have Parkinson's disease, which results in tremors, stiffness, slow movements, and difficulty moving. Within three to five years of treatment with standard Parkinson's drug treatments, many patients experience episodes of decreased mobility (such as the inability to rise from a chair, to speak, or to walk) and falling can occur during these periods.
Approximately 10% of advanced Parkinson's patients who don't respond to standard medications may benefit from Apokyn, according to the FDA.
The effectiveness of Apokyn, for the treatment of off episodes was established in three clinical trials. Apokyn is injected just under the skin. In these trials significant improvements in movement were seen in people with Parkinson's 20 minutes following injection of the medication compared with placebo injections. On average, patients participating in these trials had had Parkinson's disease for just more than 11 years and were being treated with L-dopa and at least one other medication, usually an oral dopamine agonist.
Apokyn can cause severe nausea and vomiting so it must be taken with another medication to prevent this reaction. However, it cannot be taken with one class of very effective antinausea drugs, such as Zofran, Kytrin, and Anzemet. The combination of Apokyn and these drugs can lead to very low blood pressure, fainting, and an increased risk of falling. Another drug, the irritable bowel syndrome drug Lotronex, should also not be taken with Apokyn as it can have the same severe blood pressure lowering effect.
Other drugs, taken orally, can be taken chronically to help prevent these periods of immobility in Parkinson's disease. However, Apokyn is the first drug to be used as treatment for when these off episodes occur.
The most common side effects seen were yawning, abnormal movements, nausea and vomiting, sedation or sleepiness, dizziness, runny nose, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.