Data From Zohydro(TM) ER (hydrocodone bitartrate) Phase 3 Clinical Trial Published in Pain Medicine Demonstrates Its Benefit as a Therapeutic Option for the Management of Pain Severe Enough to Require Daily, Around-the-Clock, Long-Term Opioid Treatment and for Which Alternative Treatment Options Are Inadequate

        Print
| Source: Zogenix

SAN DIEGO, Feb. 13, 2014 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of pain-related conditions and central nervous system disorders, today announced the publication of results from the Phase 3 clinical study of ZohydroTM ER (hydrocodone bitartrate) extended-release capsules, which were originally reported in 2011 and were used as the basis for the Zohydro ER new drug application ("NDA"), which was approved by the U.S. Food and Drug Administration (FDA) in October 2013. The results of Study 801 from the Phase 3 clinical study demonstrate that extended-release hydrocodone was well tolerated and effective for the treatment of moderate-to-severe chronic low back pain and was published online in the February issue of the peer-reviewed journal Pain Medicine. Pain Medicine is the official publication of the American Academy of Pain Medicine (AAPM).

The study is titled "Single-Entity Hydrocodone Extended-Release Capsules in Opioid-Tolerant Subjects With Moderate-to-Severe Chronic Low Back Pain: A Randomized Double-Blind, Placebo-Controlled Study." It is currently available to subscribers on the journal's website, and will be published in print at a later date.

"As the first and only extended-release hydrocodone without acetaminophen, we expect Zohydro ER to fill a critical need for people suffering from chronic pain who are currently experiencing pain relief with around-the-clock immediate-release hydrocodone-acetaminophen combination products but are at risk for liver toxicity. Acetaminophen overdose is a leading cause of acute liver failure in the United States with almost two-thirds of those cases related to the use of these products," said Bradley Galer, MD, executive vice president and chief medical officer of Zogenix. Dr. Galer continued, "In addition, the comprehensive suite of appropriate use initiatives for Zohydro ER that Zogenix has initiated, which augment the Risk Evaluation Mitigation Strategies (REMS) for Extended-Release/Long Acting (ER/LA) Opioids required by the FDA, is designed to support the proper prescribing and use of our product."

Overall, Zohydro ER was studied in over 1,100 patients with moderate to severe chronic pain who participated in Study 801, the pivotal Phase 3 efficacy study and Study 802, an open-label Phase 3 long-term safety study. The 801 efficacy study in subjects with chronic low back pain met the primary endpoint in demonstrating that treatment with Zohydro ER resulted in significantly improved pain relief compared to placebo. The key secondary endpoints were also achieved: a significantly higher number of subjects experienced at least 30% improvement in pain intensity from screening to end of study (67.5%, Zohydro ER versus 31.1%, placebo). The safety profile of Zohydro ER in both Phase 3 studies was generally well tolerated and the adverse reactions in ≥ 2% of patients in placebo-controlled trials include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, edema peripheral, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain and tremor. Zohydro ER will be available in six dosage strengths ranging from 10 mg to 50 mg with dosing every 12 hours.

Zohydro ER uses Alkermes Pharma Ireland Limited's patented Spheroidal Oral Drug Absorption System (SODAS®) drug delivery technology, which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.

About Zohydro ER

INDICATION

Zohydro™ ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

LIMITATIONS OF USE

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Zohydro ER is not indicated for use as an as‑needed (prn) analgesic.

Please see the Zohydro ER full prescribing information for the complete boxed warning and safety information.

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL EXPOSURE; NEONATAL OPIOID WITHDRAWAL SYNDROME and INTERACTION WITH ALCOHOL

  • Zohydro ER exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor regularly for development of these behaviors or conditions.
  • Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow Zohydro ER whole to avoid exposure to a potentially fatal dose of hydrocodone.
  • Accidental consumption of Zohydro ER, especially in children, can result in fatal overdose of hydrocodone.
  • For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome. Prolonged use during pregnancy can result in life-threatening neonatal opioid withdrawal syndrome.
  • Instruct patients not to consume alcohol or any products containing alcohol while taking Zohydro ER because co-ingestion can result in fatal plasma hydrocodone levels.

IMPORTANT SAFETY INFORMATION

Zohydro ER is contraindicated in patients with: significant respiratory depression; acute or severe bronchial asthma or hypercarbia; known or suspected paralytic ileus; and hypersensitivity to hydrocodone bitartrate or any other ingredients in Zohydro ER.

Zohydro ER contains hydrocodone, a Schedule II controlled substance. As an opioid, Zohydro ER exposes users to the risks of addiction, abuse, and misuse. As modified-release products, such as Zohydro ER, deliver the opioid over an extended period of time, there is a greater risk for overdose and death due to the larger amount of hydrocodone present.

Potential serious adverse events caused by opioids include respiratory depression, potential for misuse and abuse, CNS depressant effects, prolonged gastric obstruction, and severe hypotension. The most common adverse reactions associated with Zohydro ER ( ≥ 2%) include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain and tremor.

Zohydro ER uses Alkermes Pharma Ireland Limited's patented Spheroidal Oral Drug Absorption System (SODAS®) drug delivery technology, which serves to enhance the release profile of hydrocodone to provide extended-release pain relief relative to existing immediate-release combination products.

For more information about Zohydro ER, please visit: www.ZohydroEr.com or the Zohydro ER REMS website at www.ZohydroERREMS.com.

About Zogenix

Zogenix, Inc. (Nasdaq:ZGNX), with offices in San Diego and Emeryville, California, is a pharmaceutical company committed to developing and commercializing therapies that address specific clinical needs for people living with pain-related conditions and central nervous system disorders who need innovative treatment alternatives to help them return to normal daily functioning. The Company has commercialized two products using technology to enhance the patient experience and has a development pipeline that includes a once-monthly subcutaneous injection for schizophrenia. More information about Zogenix is available at www.zogenix.com

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 timing of the launch of Zohydro ER, the potential of Zohydro ER to compete with immediate-release hydrocodone-acetaminophen combination products, and the adequacy of the appropriate use initiatives for Zohydro . 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 press release due to the risk and uncertainties inherent in Zogenix's business, including, without limitation: the timing and success of the commercial launch of Zohydro ER; competition from other pharmaceutical or biotechnology companies; Zogenix's ability to obtain additional financing as needed to support its operations; the scope and validity of patent protection for Zohydro ER and Zogenix's ability to commercialize Zohydro ER without infringing the patent rights of others; unexpected adverse side effects or inadequate therapeutic efficacy of Zohydro ER that could limit commercialization, or that could result in recalls or product liability claims; other difficulties or delays relating to the development, testing, manufacturing and marketing of and obtaining regulatory approval for Zogenix's products; and other risks detailed in Zogenix's prior press releases as well as in public periodic 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 press 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.

ZohydroTM ER is a trademark and SUMAVEL® and DosePro® are registered trademarks of Zogenix, Inc.

SODAS® is a trademark of Alkermes Pharma Ireland Limited

FPR

Investors
Zack Kubow | The Ruth Group
646.536.7020 | 

Media
Julie Normart | WCG
415.946.1087 |