Navigation Links
Zogenix Reports FDA Provides New PDUFA Date for Sumavel(TM) DosePro(TM)
Date:2/18/2009

SAN DIEGO, Feb. 18 /PRNewswire/ -- Zogenix, Inc. ("Zogenix"), a private, specialty pharmaceutical company, announced that the U.S. Food & Drug Administration (FDA) has provided a target date of July 15, 2009 for completion of its review of the NDA for Sumavel DosePro (sumatriptan injection) needle-free delivery system. Zogenix is seeking marketing approval of Sumavel DosePro for the acute treatment of migraine attacks with or without aura, and the acute treatment of cluster headache episodes.

In October, the company received a Complete Response letter from the FDA citing the need for a single additional in vitro test to be conducted. Zogenix recently submitted this information to the FDA. The FDA has accepted this resubmission as a complete response, providing the new Prescription Drug User Fee Act (PDUFA) review date of July 15, 2009.

Sumavel DosePro uses the novel, proprietary DosePro drug delivery system to subcutaneously administer sumatriptan, a medication that has been used to treat migraines effectively and safely for over fifteen years, but without many of the issues associated with needle delivery. Sumavel DosePro has the potential of offering migraine relief beginning in as little as ten minutes, in a system sufferers can self administer in three easy steps. Given the unique attributes of Sumavel DosePro, Zogenix believes it has the potential to be used as a replacement for needle-based injectable forms of sumatriptan, as well as to replace tablet and nasal spray triptans for challenging migraine episodes.

Migraine affects approximately 30 million people in the United States. Patients suffer with extreme pain, nausea, vomiting, and sensitivity to light and sound, making it difficult to undertake work or other activities. Because of this, speed of relief is a key attribute identified by migraine patients when choosing a medication.

"We look forward to working with the FDA to help make this important alternative treatment available to patients who suffer from migraines," said Roger L. Hawley, Chief Executive Officer of Zogenix. "We are building commercial inventory and our launch plans are in place. It is our intention to launch the product following FDA approval in the second half of 2009."

About Zogenix

Zogenix, Inc., with offices in Emeryville and San Diego, Calif., is a private, specialty pharmaceutical company with two proprietary product candidates in late-stage development for the treatment of central nervous system disorders and pain. The company's lead product candidate, Sumavel DosePro, enables needle-free subcutaneous delivery of sumatriptan for the treatment of acute migraine and cluster headache. Zogenix submitted a New Drug Application with the U.S. Food and Drug Administration for Sumavel DosePro in December 2007. The company also plans to license the patented DosePro needle- free drug delivery system to other companies. The company's second product candidate, ZX002, is a novel, oral controlled release formulation of hydrocodone for the treatment of chronic pain. This product candidate has completed Phase 2 clinical trials and is ready to begin Phase 3. For additional information, visit http://www.zogenix.com.

Zogenix(TM), Sumavel(TM), and DosePro(TM) are trademarks of Zogenix, Inc.


'/>"/>
SOURCE Zogenix, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Senesco Technologies Reports Second Quarter Fiscal 2009 Financial Results
2. Gentiva Reports Fourth Quarter and Fiscal 2008 Results
3. Idenix Pharmaceuticals Reports Fourth Quarter and Year End Financial Results
4. Genesis Pharmaceuticals Reports Results for the Second Quarter of its Fiscal Year 2009
5. Pharmacyclics Reports Second Quarter Fiscal 2009 Financial Results
6. YM BIOSCIENCES REPORTS SECOND QUARTER 2009 OPERATIONAL AND FINANCIAL RESULTS
7. Shengtai Pharmaceutical, Inc. Reports Second Quarter Fiscal 2009 Financial Results
8. Neurobiological Technologies Reports Second Quarter Fiscal 2009 Financial Results
9. Corgenix Reports Second Quarter Fiscal 2009 Financial Results
10. Sigma-Aldrich (Nasdaq: SIAL) Reports Fourth Quarter Diluted EPS of $0.68. Ends 2008 With Record Sales and Earnings and Raises Quarterly Cash Dividend by 11.5%. Provides Outlook for 2009.
11. Vanda Pharmaceuticals Reports Fourth Quarter and Full Year 2008 Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/15/2017)... ... May 15, 2017 , ... Catalent ... for drugs, biologics and consumer health products, today announced that it has signed ... diseases, to support preclinical and clinical development of TA-46, a novel protein addressing ...
(Date:5/15/2017)... Calif. (PRWEB) , ... May 15, 2017 , ... ... May 1 brand refresh, the clinical skincare brand has today launched its first-ever ... mantra is now being shared across digital and social media channels, emphasizing Algenist’s ...
(Date:5/12/2017)... , May 12, 2017 GreenMark Biomedical ... present at the 36th annual Michigan Growth Capital Symposium ... a Delaware corporation with facilities ... to investors in attendance, including more than 100 top ... benefits to society through biobased targeting technologies. ...
(Date:5/11/2017)... --  BioLife Solutions , Inc. (NASDAQ: BLFS ), ... cell and tissue hypothermic storage and cryopreservation ... highlights and financial results for the first quarter of 2017. ... new high of $2.4 million in the first quarter of ... 2016. Revenue growth was driven by sales of CryoStor ...
Breaking Biology Technology:
(Date:4/11/2017)... , April 11, 2017 No ... but researchers at the New York University Tandon ... of Engineering have found that partial similarities between ... systems used in mobile phones and other electronic ... The vulnerability lies in the fact ...
(Date:4/5/2017)... 2017 KEY FINDINGS The global ... a CAGR of 25.76% during the forecast period of ... factor for the growth of the stem cell market. ... MARKET INSIGHTS The global stem cell market is ... geography. The stem cell market of the product is ...
(Date:3/30/2017)... YORK , March 30, 2017 Trends, ... type (physiological and behavioral), by technology (fingerprint, AFIS, iris ... voice recognition, and others), by end use industry (government ... and immigration, financial and banking, and others), and by ... Europe , Asia Pacific , ...
Breaking Biology News(10 mins):