San Diego-based Zogenix (NASDAQ: ZGNX) has an update today on its development of an extended-release and acetaminophen-free formulation of the painkiller, hydrocodone bitartrate, which the company plans to market as Zohydro oral capsules.
After agreeing on submission requirements for its reformulated drug in a series of meetings with regulators at the FDA, Zogenix says it plans to submit its new drug application for Zohydro by mid-May. The company says it is seeking clearance under a section of the Food and Drug Act that allows a new drug candidate to rely on studies already published in the scientific literature or the FDA’s own finding of safety and effectiveness of a previously approved drug product.
In its statement today, Zogenix says Zohydro is being evaluated for the management of moderate-to-severe chronic pain in patients requiring around-the-clock opioid therapy for an extended period. If approved, Zohydro could be the first extended-release hydrocodone therapy available without acetaminophen, which is associated with an increased risk of liver toxicity when used in high doses over time.
The formulation relies on proprietary extended-release technology that was developed by Alkermes (NASDAQ: ALKS), the drugmaker based in Dublin, Ireland, that Zogenix chose as its chemistry and manufacturing controls (CMC) partner.
If the NDA is approved, Zogenix has said it could begin marketing the drug as early as 2013. The company estimates that more than 128 million prescriptions are written in the U.S. each year for hydrocodone drugs, a potential $7.5 billion market opportunity.
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