Zogenix Strategy Unfolds as it Unveils Plans for Next Drug-and-Device Combo

Xconomy San Diego — 

When I talked to Zogenix CEO Roger Hawley last summer about the San Diego company’s development of a needle-free drug delivery device, he said the startup’s plan hadn’t changed much since Zogenix (NASDAQ: ZGNX) was founded in 2006. The company began selling its first product, a needle-free device with a fast-acting painkiller for migraines, early last year, after winning FDA clearance for the device-and-drug combo in 2009.

Almost a year later, Hawley says the company’s story still hasn’t changed, even though Zogenix recently disclosed it has signed an agreement to collaborate with Cupertino, CA-based Durect (NASDAQ: DRRX) to develop Durect’s long-lasting reformulation of the anti-psychotic drug risperidone (Risperdal) for use with the Zogenix needle-free injector.

If approved, the companies say the controlled release formulation would be the first once-a-month antipsychotic drug available in a needle-free delivery system. Johnson & Johnson already markets a long-lasting, once every-other-week injectable form of risperidone, under the trade name Risperdal Consta.

If the new antipsychotic drugs sounds like a departure from Zogenix device-and-drug combo debut with the painkiller sumatriptan, Hawley says it’s nevertheless part of the plan. Zogenix always wanted to develop a series of drugs it could combine with its DosePro needle-free device, which is sold by prescription with a single dose and discarded after each use. The company also planned all along to target its drug development on the central nervous system (CNS). Hawley points out that a migraine is just as much a CNS disorder as schizophrenia. It’s just that a neurologist usually writes the prescription for a migraine while psychiatrists usually end up seeing patients with schizophrenia.

Risperidone is one of the most widely prescribed medications used to treat schizophrenia and biopolar I disorder in adults, according to Zogenix. Even though a long-acting version of risperidone already is on the market, Zogenix sees an opportunity because the existing long-acting version requires injecting 2 or more milliliters of the drug into the muscle twice a month —using a 21 gauge hypodermic needle (almost one-third inch in diameter).

Using a Zogenix needle-free device to inject the anti-psychotic drug once a month—and just beneath the skin—could give the psychiatric community a better way to keep schizophrenic patients in compliance with their regular dose regimens, Hawley says. Long-lasting injections are considered useful in … Next Page »

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