Zogenix Sets Timetable for New Painkiller Drug

hydrocodone, hydrocodone bitartrate

San Diego-based Zogenix (NASDAQ: [[ticker: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: [[ticker: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.

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.