San Diego’s Zogenix Moving Fast to Commercialize Drug-and-Device Combo

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drug-device combination. “The device really has global potential,” Hawley says. “No one else can do what we do”

The DosePro injector resembles a pen and each one comes filled with a fixed dose of sumatriptan. The device uses the sudden release of nitrogen gas to drive a piston at a fixed pressure. The piston, in turn, pushes the drug through a laser-drilled hole at the tip of a capsule, where a small amount of the drug forms a liquid jet. The drug is delivered just under the skin—as a liquid—in less than 1/10th of a second. The “hole” in the skin is about 0.3mm, similar or smaller to a hypodermic needle. Because there is no needle, nothing beneath the skin gets pierced—including blood vessels, according to Zogenix spokeswoman Catherine O’Connor.

Of course, O’Connor adds that “Needle-free” doesn’t necessarily mean “pain-free.” Patients in three Zogenix studies described the sensation of the needle-free injection as mild discomfort to mild pain. O’Connor says they rated the pain as a “2” on a 1-to-10 pain scale (with 0 being no pain).

DosePro’s big advantage, Hawley says, is that “it’s single-use, needle-free and fully disposable.” Zogenix’ studies also show that 98 percent of patients could get it right on their first try at home, and Hawley says, “for a drug-device combination, that’s unusual.”

DosePro Demo

DosePro Demo

The Zogenix technology is currently more expensive than rival needle-free, pin-based auto-injectors that patients can buy for $5 to $7 apiece to self-administer injections. But Hawley says it is usually necessary for patients to load the drug into those devices themselves. As for the cost, Hawley says, “The difference in cost, quite honestly, is that those auto-injectors are now made at scale; a lot of companies are using them. Our technology is new; we’re the only one who manufactures it. We think over time, with more volume, we can actually get fairly close to those auto-injector costs with much more convenience.”

What’s less clear, to me at least, is what advantages the DosePro device has over an existing pen-style, auto-injector, which comes with a pre-filled drug dose.

Hawley says the needle-free design addresses patients’ needle anxiety and eliminates needle disposal issues and the risk of needle stick injuries. Zogenix marketing materials suggest another important reason could be that the DosePro technology, as a … Next Page »

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