Zogenix Inc was formed as a Delaware Corporation on May 11, 2006. The Company is a pharmaceutical company that develops and commercializes therapies that address specific needs for people living with pain-related conditions and central nervous system disorders who needs treatment alternatives to help them return to normal daily functioning. The Company's first commercial product, Sumavel DosePro 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 U.S. Food and Drug Administration, or 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. The Company's main product candidate, Zohydro ER, is a 12-hour extended-release formulation of hydrocodone without acetaminophen for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternate treatment options are inadequate. The Company also develops Relday, a proprietary, long-acting injectable formulation of risperidone using Durect Corporation's SABER controlled-release formulation technology through a development and license agreement with Durect Corporation. The Company's competitors include: AstraZeneca plc, Endo Pharmaceuticals Holdings Inc., Johnson & Johnson, Merck & Co., and Pfizer, Inc. In the United States, pharmaceutical products are subject to extensive regulation by the FDA. Its trademarks include DosePro, Relday, Zogenix and Zohydro ER. The Company is subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act, or FFDCA, and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products.
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