FDA approves Apokyn for acute treatment of immobility episodes in Parkinson's patients
ROCKVILLE, MD., April 21, 2004 -- The FDA has approved Apokyn (apomorphine) as an injectable drug for treating Parkinson's patients during episodes of "hypomobility" -- so-called "off periods" in which the patient becomes immobile or unable to perform activities of daily living.
Apokyn was given priority review because injectable apomorphine is the first therapy approved to treat these episodes acutely (during the episode). Apokyn was also designated as an orphan product.
An estimated 1.5 million Americans have Parkinson's disease, which results in tremors, rigidity, postural instability, slowness, and difficulty moving. Within 3 to 5 years of treatment with standard Parkinson's drug treatments, about ten percent of patients experience episodes of hypomobility (e.g., inability to rise from a chair, to speak, or to walk). The episodes can occur toward the end of a dosing interval with standard background medications (so-called "end-of-dose wearing off") or at unpredictable times (spontaneous "on/off").
Apokyn was designated an orphan drug in l991 to treat the ten percent, or about 112,000 Parkinson's patients who progress to stage four and experience the severe on/off motor fluctuations unresponsive to other therapies. Orphan drugs are drugs that treat a rare disease or condition which affects fewer than 200,000 patients in the U.S. After receiving FDA approval, orphan drugs are eligible for seven years of exclusive marketing.
The effectiveness of Apokyn in the acute symptomatic treatment of both types of recurring episodes of hypomobility or "off" episodes associated with advanced Parkinson's disease was established in three randomized, controlled trials. On average, patients participating in these trials had had Parkinson's disease for 11.3 years and were being treated with L-dopa and at least one other agent, usually an oral dopamine agonist.
Apokyn must be taken with an antiemetic drug because, when taken alone, it causes severe nausea and vomiting. It must not be taken with one class of very effective anti-nausea drugs, the 5HT3 antagonists (ondansetron and similar drugs), because the combination of Apokyn (apomorphine) and these drugs can lead to very low blood pressure and loss of consciousness.
Apokyn is intended for subcutaneous injection only. Other oral drugs, taken chronically, are also used to help decrease the amount of time Parkinson's patients spend in the "off" state.
Patients and caregivers should carefully read the Patient Package Insert and Directions for Use on the ampule and dosing pen. Patients should also be instructed to use the drug only as prescribed.
Apokyn's labeling also includes specific warnings about low blood pressure, fainting, hallucinations, and excessive sleepiness.
The most common adverse events seen in controlled trials were yawning, dyskinesias (abnormal movements), nausea and vomiting, sedation or sleepiness, dizziness, runny nose, hallucinations, edema, chest pain, increased sweating, flushing, and pallor.
Apokyn is a new molecular entity -- a medication containing an active substance that has never before been approved for marketing in any form in the United States. It is manufactured for Bertek Pharmaceuticals by Draxis Pharma Inc., Canada.
Posted: April 2004