The pharmaceutical company Zogenix, Inc. (Nasdaq:ZGNX), who commercializes and develops drugs for the treatment of central nervous system disorders and pain, today announced positive top-line results from its pivotal Phase 3 efficacy study (Study 801) of Zohydro(TM) (hydrocodone bitartrate) extended-release capsules.
Zohydro is currently being assessed to treat moderate to severe chronic pain in patients requiring around-the-clock opioid therapy for extended periods of time. If the drug is approved, it could represent the first extended-release hydrocodone treatment on the market without acetaminophen, which is linked to an increased risk of liver toxicity when used in high doses over extended periods of time. Zogenix intends to submit a New Drug Application (NDA) to seek approval for Zohydro to the U.S. Food and Drug Administration (FDA) by early 2012 and, if successful, anticipates the product launch to be in 2013.
With more than 131 million prescriptions filled in 2010, Hydrocodone pain products represent the largest prescription drug category in the United States. Zohydro's ability to consistently deliver hydrocodone over an extended period of time without exposure to acetaminophen is believed to achieve a good position in the large market of pain relief drugs.
Zohydro successfully met the primary efficacy endpoint of the study in a trial displaying significant evidence (p=0.008) of improving chronic pain relief compared to placebo and also met the two key secondary endpoints, in particular the proportion of patients with at least 30% improvement in pain intensity and the improvement of overall satisfaction of medication.
Additional study endpoints confirmed Zohydro's effectiveness compared to placebo and affirmed, that Zohydro was safe and well tolerated. Patients treated with Zohydro reported >5% of adverse events, including constipation, nausea and urinary tract infection.
"We are very encouraged by the study results, which we believe are meaningful for patients suffering from moderate to severe chronic pain. Zohydro will offer hydrocodone for the first time in a convenient 12-hour dose while eliminating acetaminophen,"
said Stephen J. Farr, Ph.D., President and Chief Operating Officer of Zogenix. He continued,
"Zohydro may simplify physicians' ability to prescribe the appropriate hydrocodone dose for chronic pain while managing the inadvertent overuse of acetaminophen, which is a common ingredient in combination pain products and over-the-counter medications."
Study 801 is part of the ongoing Phase 3 program for Zohydro. In addition, Study 802, an open-label safety study is ongoing in patients with moderate to severe chronic pain. The studies will be completed in the third quarter of 2011 to support an NDA filing as one of the FDA's long-term safety data requirements.
Roger Hawley, Chief Executive Officer of Zogenix commented,
"These positive results represent an important step forward in the commercialization of our extended-release hydrocodone. Adding Zohydro as our second commercial product would be transformational for Zogenix's business, given the number of chronic pain patients and the growing physician demand for an acetaminophen-free hydrocodone product. If approved, as planned, we intend to expand our sales force in order to be in a position to educate prescribers about this important new option for chronic pain management and assume a greater promotional responsibility for SUMAVEL DosePro."
Later this year, a further discussion about the Zohydro phase 3 program will be presented at the Company's investor meeting in New York. Details about the Zogenix Investor Meeting will be released in a separate announcement.
About the Phase 3 Efficacy Study (801)
Study 801 was a multi-center randomized, double-blind, placebo-controlled study of over 300 opioid-experienced patients between the ages of 18-75 years, who had an established clinical diagnosis of moderate to severe chronic lower back pain and inadequate pain relief from their existing therapy.
The trial was conducted as an open-label conversion and titration phase of Zohydro followed by a 12-week placebo-controlled treatment phase comparing Zohydro 20-100 mg every 12 hours to placebo.
The primary objective of this trial was to assess Zohydro's relative efficacy as measured by the change from baseline to the end of treatment in pain intensity. The trial guidelines defined the primary endpoint as the mean change from baseline to the end of the 12 week treatment phase in the average 24-hour pain intensity ratings, based on the 0-10 Numerical Rating Scale (NRS) from daily electronic diaries comparing Zohydro and placebo.
About Zohydro
Zohydro is a novel, oral, single entity (without acetaminophen) extended-release capsule formulation of hydrocodone bitartrate. Acetaminophen can cause liver toxicity when used in high dosages over time. If approval is granted, Zohydro could be the first single-entity hydrocodone therapy available using Elan's patented Spheriodal Oral Drug Absorption System (SODAS(R)) drug delivery technology, which enhances the release profile of hydrocodone, providing consistent 12-hour pain relief relative to existing immediate release combination products. Phase 3 utilized Capsule strengths of 10, 20, 30, 40 and 50 mg capsules.
About Chronic Pain
According to The American Pain Society, an estimated 9% of the U.S. population suffered from moderate to severe non-cancer related chronic pain in 1999.
Treatment for chronic pain can be with immediate-release and extended-release opioids. The most commonly prescribed pharmaceuticals in the U.S. are marketed hydocodone products with a yearly sale of $3.2 billion at the end of December 2010 (Wolters Kluwer Pharma Solutions, Source Pharmaceutical Audit Suite Retail, January 2010 -- December 2010).
Every one of these hydrocodone products contains an analgesic combination ingredient, mainly acetaminophen, which is linked to an increased risk of liver toxicity when used in high dosages over time.
Writen by Petra Rattue