Apokyn Approved for Parkinson's Symptoms
The Food and Drug Administration (FDA) on Tuesday approved the marketing of apomorphine hydrochloride for the acute treatment of bouts of immobility suffered by some patients with Parkinson's disease.
Mylan Laboratories declared in a statement that the product, an orphan drug to be sold as Apokyn, will be available in July through a "limited specialty pharmacy network." FDA-approved labeling for apomorphine is not yet available.
According to FDA, apomorphine causes severe nausea and vomiting and must be taken with an antiemitic drug other than a serotonin type-3 receptor (5-HT3) antagonist. Concurrent use of apomorphine and a 5-HT3 antagonist can cause dangerously low blood pressure and fainting, according to the agency.
In clinical trials, side effects associated with apomorphine included involuntary movements, nausea and vomiting, somnolence, dizziness, and hallucinations.
Apomorphine is administered subcutaneously with a dosing pen, according to FDA. The agency stated that apomorphine can supplement oral therapies that are taken for the chronic control of immobility episodes.