A generic version of a cartridge treatment – used for periods when regular Parkinson’s medication doesn’t function properly – got approval last month.
The U.S. Food and Drug Administration first approved apomorphine hydrochloride injection, also known by the brand name Apokyn, in 2004 to treat “off” times for Parkinson’s patients. According to the Michael J. Fox Foundation for Parkinson’s Research, “off” times refers to the periods when a person’s medication is not functioning correctly and the individual is experiencing resurgent Parkinson’s symptoms.
An “off” time can be caused by a medication wearing off, so it’s sometimes experienced in the morning before medication is taken or right before another dose is scheduled. Multiple quick-acting treatments are available for these periods of time, including inhalers and strips that dissolve under the patient’s tongue. The FDA’s new approval is specifically for the cartridge of an “EpiPen”-like device that a patient or caregiver can inject.
The FDA stressed in its approval that only the drug is approved to be genericized; patients will still need the brand-name pen device.
“Prescribers and pharmacists should be aware that patients starting treatment with generic apomorphine hydrochloride injection will need to separately obtain the Apokyn Pen,” reads the FDA’s approval message. “The Apokyn Pen is supplied by the brand manufacturer, is distributed and packaged separately, and is generally only dispensed through specialty pharmacies.”
The branded pen has a 29-gauge needle, a very narrow needle similar in size to diabetic insulin needles, and a replaceable cartridge chamber. The 3 mL cartridges can be used multiple times. Generic approval, which can be granted by the FDA after 17 years of patented use, usually means drugs can be sold by other manufacturers at lower prices. Prices for the drug vary, but both Drugs.com and GoodRx list Apokyn for around $400 per milliliter. No price point for any generic version of the drug has been revealed yet, but the Federal Trade Commission says generic versions of drugs generally cost anywhere from 20 to 70% less than the brand-name version.
