In a Detour From Device Strategy, Zogenix Edges Closer to New Drug Application

Xconomy San Diego — 

San Diego-based Zogenix, a specialty pharma that has been selling its first product (a fast-acting migraine drug in a single-dose injector) for 22 months, is getting ready to diversify its portfolio.

As we reported in August, Zogenix successfully completed its late-stage safety and efficacy trials for an extended-release formulation of the painkilling drug hydrocodone bitartrate (Zohydro). Earlier this month, Zogenix executives told me they are doing the final analyses of their clinical findings for the drug, which is intended to provide lasting relief for people with chronic pain. Zogenix says it plans to submit a new drug application (NDA) in early 2012.

If Zogenix wins FDA approval, the company says it could begin marketing for its second product in 2013, calling it the first extended-release painkiller in the hydrocodone class—a drug category that includes acetaminophen/hydrocodone (Vicodin) and acetaminophen/oxycodone (Percocet). Zogenix says its pain-killer also would be the first “single-entity” hydrocodone (i.e. acetaminophen-free), which became a relevant selling point earlier this year, when the FDA announced a limit on how much acetaminophen could be used in combination drugs and required liver toxicity warnings.

With its clinical trials basically completed, Zogenix CEO Roger Hawley says the company plans to meet with FDA regulators in coming weeks in preparation for its NDA submission sometime after January 1. (The company also plans to release its third-quarter earnings on Nov. 10.)

Zogenix has based its core, long-term strategy on its needle-free DosePro technology, which uses pressurized nitrogen gas to drive a liquid jet of a prescribed drug under the skin in less than 1/10th of a second. The FDA cleared the company to sell its first drug-and-device product, the DosePro with a fixed dose of the painkiller sumatriptan, in 2009. Zogenix plans to build its business on a series of similar drug-and-device combinations focused on diseases and disorders of the central nervous system, and could even license its DosePro technology.

The bad news is that each drug-and-device combo will require a separate FDA review. The good news, however, is that each combo is considered unique—and therefore eligible for patent protection. Even if patent protection for a particular drug has expired, Zogenix says it … Next Page »

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