SAN DIEGO, Feb. 11, 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 it has made significant progress in preparing for the market launch of Zohydro TM ER (hydrocodone bitartrate) extended-release capsules, approved by the U.S. Food and Drug Administration in October 2013. Zohydro ER, the first and only extended release hydrocodone without acetaminophen, is indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. For patients managing chronic pain with an immediate release hydrocodone combination product, an extended release formulation without the risks associated with acetaminophen may be beneficial. Zohydro ER may also be an alternative for people living with chronic pain who have developed opioid tolerance or are experiencing side effects with other long-acting opioids.
In preparation for commercial launch, the company has completed a significant organizational expansion, increasing its employee footprint to approximately 250. Zogenix has recruited professionals with extensive experience in the pain management marketplace to contribute to a full range of commercial operations including sales and marketing, managed markets and trade team. Zogenix has also assembled an impressive medical affairs leadership team as announced in December 2013. All 150 territory representative positions have been filled and comprehensive training began February 3 rd, and will continue throughout the month. Manufacturing of Zohydro ER has also been completed and the product is ready for shipment to wholesalers. The company believes that adequate inventory is in place to meet anticipated launch demand for the product.
These preparations place Zohydro ER's commercial launch on track for early March.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.