Zohydro NDA Submission on Track
SAN DIEGO, Dec. 20, 2011 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain, today announced that it has concluded its pre-New Drug Application (NDA) meetings with the U.S. Food & Drug Administration (FDA) related to its lead investigational product candidate, Zohydro™ (hydrocodone bitartrate extended-release capsules). The purpose of the meetings was to discuss the non-clinical, clinical and Chemistry, Manufacturing and Controls (CMC) development of Zohydro, and to agree on the submission requirements for the NDA submission under 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. After a detailed review of the submission timeline, Zogenix plans to submit the NDA for Zohydro early in the second quarter of 2012.
Stephen Farr, PhD, president and chief operating officer of Zogenix, said, "The completion of our pre-NDA meetings with the FDA brings us one more important step closer to potentially gaining approval for Zohydro. We appreciate the informative interactions, timeliness, and clarity provided by the FDA, as well as the full support of Alkermes, our CMC partner, in the pre-NDA meeting process."
Zohydro is being evaluated for the management of moderate to severe chronic pain in patients requiring continuous around-the-clock opioid therapy for an extended period of time. 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.
Hydrocodone pain products represent the largest prescription drug category in the United States, with over 128 million prescriptions filled in 2010. The Company believes Zohydro's ability to provide consistent 12-hour pain relief, without exposure to acetaminophen, will position the product well in this large market.
Zohydro is a novel, oral, single entity (without acetaminophen) extended-release capsule formulation of hydrocodone bitartrate. When used in high dosages over time, acetaminophen can cause liver toxicity. If approved, Zohydro could be the first single-entity hydrocodone therapy available. Zohydro uses Alkermes' patented Spheriodal Oral Drug Absorption System (SODAS®) drug delivery technology which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate release combination products. Capsule strengths utilized in the Phase 3 studies included 10, 20, 30, 40 and 50 mg capsules.
About Chronic Pain
The American Pain Society estimated in 1999 that 9% of the U.S. adult population suffers from moderate to severe non-cancer related chronic pain. Chronic pain can be treated with both immediate-release and extended-release opioids. Marketed hydrocodone products are the most commonly prescribed pharmaceuticals in the U.S., generating $3.2 billion in sales during the 12 months ended December 2010 (Wolters Kluwer Pharma Solutions, Source Pharmaceutical Audit Suite Retail, January 2010 – December 2010). All of these hydrocodone products contain an analgesic combination ingredient, primarily acetaminophen. Acetaminophen may cause liver toxicity when used in high dosages over time.
Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company commercializing and developing products for the treatment of central nervous system disorders and pain. Zogenix's first commercial product, SUMAVEL® DosePro® (sumatriptan injection) Needle-free Delivery System, was launched in January 2010 for the acute treatment of migraine and cluster headache. Zogenix's lead investigational product candidate, Zohydro™ (hydrocodone bitartrate), is a novel, oral, single-entity (without acetaminophen) extended-release capsule formulation currently in Phase 3 clinical trials for the management of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zogenix's second investigational DosePro product candidate, Relday™, is a proprietary, long-acting injectable formulation of risperidone for the treatment of schizophrenia.
Forward Looking Statements
Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the company's current beliefs and expectations. These forward-looking statements include statements regarding: the potential for, and timing of, an NDA submission for Zohydro; the potential for Zohydro to be the first approved oral, single-entity extended-release formulation of hydrocodone; and the size of the opioid pain market and the potential of Zohydro to be well positioned in that market. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the top-line data Zogenix has reported for Zohydro is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial, and may also change in connection with the continued review of such data as part of Zogenix's planned submission and the FDA's review of the NDA for Zohydro; the progress, timing and results of the planned bioequivalence study for Zohydro; the potential that earlier clinical trials may not be predictive of future results; the potential for Zohydro to receive regulatory approval on a timely basis or at all; the potential for adverse safety findings relating to Zohydro to delay or prevent regulatory approval or commercialization; the impact of any inability to raise sufficient capital to fund ongoing operations; the ability of Zogenix and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its products and product candidates and the ability to operate its business without infringing the intellectual property rights of others; and other risks described in Zogenix's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
SODAS® is a trademark of Alkermes plc.
SUMAVEL®, DosePro®, ReldayTM and ZohydroTM are trademarks of Zogenix, Inc.
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646.536.7013 | email@example.comZogenix