SAN DIEGO, Nov. 1, 2013 (GLOBE NEWSWIRE) -- Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, today announced that it has entered into a Development and Option Agreement ("D&O Agreement") with Altus Formulation Inc. ("Altus"), a private Montreal-based drug formulation and development company, to develop abuse deterrent formulations of Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, using Altus's proprietary Intellitab™ drug delivery platform. Concurrent with entry into this agreement, Altus and Zogenix have initiated development of alternative abuse deterrent formulations of Zohydro ER.

Under the D&O Agreement, Altus has granted Zogenix an option (subject to the terms and conditions of the D&O Agreement) to enter into an exclusive license on mutually agreed terms to develop and commercialize abuse deterrent formulations of Zohydro ER in the United States. In connection with the transaction, Zogenix will pay Altus a technology access fee in the amount of $750,000. Zogenix will fund all development activities, and Altus may earn up to an additional $3.5 million in development and regulatory milestones through submission of a New Drug Application (NDA) under the D&O Agreement. Following exercise of the option, Altus will be eligible to receive additional undisclosed regulatory and sales milestone payments and a royalty based on net sales of the licensed product.

Dr. Stephen Farr, president, Zogenix, said, "We are excited to be working with our colleagues at Altus towards development of an abuse deterrent formulation of Zohydro ER consistent with the Food & Drug Administration's draft guidance for industry on the evaluation and labeling of abuse deterrent opioids. The technology developed by Altus can be customized to match the current pharmacokinetic profile of Zohydro ER, which we believe, in turn, will allow us to bridge to the safety and efficacy established in the recently approved New Drug Application." 

Dr. Damon Smith, CEO of Altus Formulation, said, "We are delighted that Zogenix has chosen to work with Altus and Intellitab technology on the development of an abuse deterrent formulation of Zohydro ER."

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 (