OR WAIT null SECS
Two prefilled-syringe projects emphasize user friendliness
It is no longer sufficient to have a valued specialty pharmaceutical available in prefilled-syringe form; now, manufacturers and syringe developers are competing to provide the best convenience and safety factors with their delivery systems.
Cases in point are Teva Pharmaceuticals, which recently concluded a year of testing (with syringe provider Becton Dickinson) to redesign an existing syringe for Copaxone (glatiramer acetate injection), a treatment for multiple sclerosis (MS). Another action comes from West (Lionville, PA), which has joined up with a design firm, Insight Product Development LLC (Chicago) to offer Confidose, a disposable auto-injector system for self-injection therapy that was announced last fall. It’s in the final stages of development and not yet on the market, but West is showing it to clients.
Confidose incorporates an affixed needle prefilled syringe format that can be used with either a glass or crystalline plastic syringe. When the user presses a button, a needle extends to deliver a dose of medication and then retracts. After use, the needle is shielded within the system to prevent needle-stick injury and to make the system safe for disposal. Confidose is assembled by the pharmaceutical manufacturer with individual doses of medication in prefilled syringes.
West brings components expertise to the deal, thanks to its experience in manufacturing such drug-administration safety devices as stoppers and seals for vials and plungers, as well as prefillable syringe components, says Chris Evans, manager for innovation concepts. He says West has made a corporate decision to be more than a maker of component rubber compound products. “We wanted to become a developer of design platforms, and of the intellectual property to be used.”
Clinicians, patients, and doctors sometimes have difficulty articulating what they like or dislike in a medical device, or describing the features they want, says Evans. “You have to extract it from them.” That’s what Insight brings to the deal—years of medical device user research. It combines that knowledge with product development methods that integrate compliance and FDA requirements, he says. “Insight provides West customers with access to more than 20 years of experience in product development, conceptual design, and research methods capabilities.”
Thinner steel, higher tolerability
Teva has redesigned its syringe to use a thinner steel (29 gauge versus 27 gauge) to make the self-injection process less irritating. Testing showed that about two-thirds of patients experienced less pain, and nearly half had a better experience dealing with injection-site reactions (a lump or rash is one of the side effects of the drug administration).
John Hassler, VP for marketing for Teva Neuroscience, says that the company has conducted a steady process of improving the drug administration process since it was introduced. “We began with a product that needed to be kept frozen, and now we have one that only needs refrigeration,” he says. “With a long-term treatment like Copaxone, anything you can do to improve convenience and tolerability means better patient acceptance and ultimately better health outcomes,” he says.
Coincidentally, FDA has recently approved Copaxone for an expanded indication, “clinically isolated syndrome (CIS) suggestive of MS.” Roughly speaking, patients can have single neurological events suggestive of MS before the disease progresses to “clinically definite MS” (CDMS). The treatment slows the progression of the disease. The expanded indication has also been approved in Europe.
The expanded use follows a three-year, Phase III study conducted at 80 centers around the world, according to Teva. Called the PreCISe study, the research included MRI examinations to determine the development of lesions indicative of the disease. PC