PRODUCT AND PRODUCT CANDIDATES
SUMAVEL® DosePro™
(sumatriptan injection)
Needle-free DELIVERY SYSTEM
Our first commercial product, SUMAVEL DosePro™ (sumatriptan injection) Needle-free Delivery System, was launched in January 2010. SUMAVEL DosePro offers fast-acting, easy-to-use, needle-free subcutaneous administration of sumatriptan for the acute treatment of migraine and cluster headache in a pre-filled, single-use delivery system. SUMAVEL DosePro is the first drug product approved by the FDA that allows for the needle-free, subcutaneous delivery of medication. SUMAVEL DosePro may offer a faster-acting and more efficacious treatment alternative to oral and nasal triptans and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. As a result, we believe that SUMAVEL DosePro has the potential to be prescribed by a broad physician audience, especially for difficult to treat migraine episodes.
ZX002
Our lead product candidate, ZX002, is a novel, oral, single-entity controlled-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. ZX002 utilizes Elan Pharma International Limited’s proprietary Spheroidal Oral Drug Absorption System, or SODAS® Technology, which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate-release combination formulations. Most marketed hydrocodone products contain the analgesic combination ingredient acetaminophen, which if taken in high quantities over time can cause liver toxicity. ZX002, if approved, may represent the first available controlled-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. As a result, we believe ZX002 could generate sales from both patients who are using immediate-release opioid products on a chronic basis and patients already using extended-release opioids. We initiated the Phase 3 clinical development program for ZX002 in March 2010.
