Navigation Links
Sumavel(TM) DosePro(TM) (sumatriptan injection) Approved by FDA for Acute Migraine and Cluster Headache: First Product Featuring Novel DosePro Needle-Free Delivery System
Date:7/16/2009

SAN DIEGO, July 16 /PRNewswire/ -- Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro (sumatriptan injection) needle-free delivery system to treat acute migraine, with or without aura, and cluster headache. Sumavel DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients.

"In my 28 years treating migraine patients, a consistent challenge has been delivering fast relief in a patient acceptable form," said Roger K. Cady, M.D., director of the Headache Care Center in Springfield, Mo. "Sumavel DosePro will be a welcome treatment option because it combines key benefits - the rapid efficacy of subcutaneous sumatriptan and a simple to use needle-free delivery system."

Triptans, the most commonly prescribed class of drugs for the treatment of migraine, are a $3.3 billion market in the U.S. (Source: Wolters Kluwer Health, Source(R) Pharmaceutical Audit Suite (PHAST). Based on AWP for U.S. retail prescriptions of drugs in the triptan market, May 2008 --April 2009.) According to the National Headache Foundation, acute migraines affect nearly 30 million Americans. Tablets are a treatment option for some migraine sufferers, but not all patients are satisfied with tablet therapy. Fast-acting, non-oral options are needed particularly for those who experience migraine episodes associated with sudden onset, waking, nausea or vomiting.

The FDA approval of Sumavel DosePro is based on extensive efficacy and safety data from original filings for needle-based sumatriptan injection (IMITREX((R))), in addition to clinical studies conducted by Zogenix on bioequivalence, usability and saf
'/>"/>

SOURCE Zogenix, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. Zogenix Reports FDA Provides New PDUFA Date for Sumavel(TM) DosePro(TM)
2. New 200 mg Vial for Eloxatin(R) (Oxaliplatin Injection) Offers Greater Convenience and Efficiency of Preparation
3. FDA Approves Astellas Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia
4. Shires ELAPRASE(R) (idursulfase) Approved in Japan for the Treatment of Hunter Syndrome
5. Anesiva Outlines Comprehensive Commercialization Plan for FDA Approved Product Zingo(TM)
6. Healthcare Announced That an Overwhelming Majority of its Shareholders Approved the NexGen Biofuels Transaction
7. Bystolic(TM), a Novel Beta Blocker, is Now Approved by the FDA for the Treatment of Hypertension
8. Avastin Approved in Europe for First-Line Treatment of Patients With Advanced Kidney Cancer
9. EVICEL(TM) Fibrin Sealant (Human) Approved for General Hemostasis in Surgery
10. Clexane(R)/Lovenox(R) Approved in Japan
11. Shires ELAPRASE(R) (idursulfase) Approved in Mexico for Treatment of Hunter Syndrome
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/17/2015)... 17, 2015  Guggenheim Securities, the investment banking and ... hiring of William Tanner as a Managing ... Tanner will start work at Guggenheim in May 2015 ... office. "Bill brings a wealth of biotech ... experienced and highly acclaimed healthcare team," said Matthew ...
(Date:4/17/2015)... WI (PRWEB) April 17, 2015 ... sales and marketing support for the powerful Orthogonal ... the Chemical Genomics Center at the Lankenau Institute ... LCGC’s mission is to measurably improve successful drug ... HTS, by offering rare, drug-like libraries available nowhere ...
(Date:4/16/2015)... 2015 Cytokinetics, Incorporated (Nasdaq: CYTK) announced ... results on Thursday, April 30, 2015 at 4:00 PM ... host a conference call at 4:30 PM Eastern Time ... outlook for the future. , The conference call will ... homepage and in the Investor Relations section of Cytokinetics’ ...
(Date:4/16/2015)... Regis Technologies looks forward to being part ... (AACR) annual meeting. Regis will exhibit at this year's ... 18, in Philadelphia and running through April 22, 2015. ... oldest and largest organization focused on cancer research. It ... with survivors to promote awareness and research funding. ...
Breaking Biology Technology:Guggenheim Securities Hires Biotech Analyst William Tanner in Expansion of Healthcare Coverage 2BellBrook Labs and Lankenau Institute Partner to Accelerate Drug Discovery using Orthogonal Pooled Screening 2Cytokinetics to Announce First Quarter Results on April 30, 2015 2Cytokinetics to Announce First Quarter Results on April 30, 2015 3Regis Technologies Joins American Association for Cancer Research Annual Meeting 2
... Biotherapeutics Holdings Inc. (Nasdaq: TLCR ) announced today ... Court Division, Wake County, North Carolina, rendered a verdict on ... favor of Plasma Centers of America, LLC, against its subsidiary, ... Talecris had a three-year Plasma Sale/Purchase Agreement with ...
... know right away that it,s hot. Ouch! But you can,t ... Rice University researchers say they have the next best ... molecule or flowing electrons by using Raman spectroscopy combined with ... of Douglas Natelson, a Rice professor of physics and astronomy, ...
... Dec. 13, 2010 BioTrends Research Group, Inc. ... oral disease-modifying agent (DMA) for the treatment of multiple sclerosis ... MS market. One month after the launch of Gilenya, trial ... year earlier, continues to be tempered due to the perception ...
Cached Biology Technology:Talecris Biotherapeutics Announces Jury Verdict in Contract Dispute 2Rice researchers take molecule's temperature 2Rice researchers take molecule's temperature 3With the Recent Launch of Novartis's Gilenya, Extavia is Pushed Into the Background of Multiple Sclerosis Treatment One Year After its Launch 2With the Recent Launch of Novartis's Gilenya, Extavia is Pushed Into the Background of Multiple Sclerosis Treatment One Year After its Launch 3
(Date:4/2/2015)... , April 2, 2015 ... Q1 2015 attributed to somewhat higher than 125 MSEK. ... the year-end report 2014 that revenues for Q1 2015 ... the company reported for Q4 2014. The operating result ... be negative. The complete interim report will as previously ...
(Date:4/1/2015)... BOSTON , April 1, 2015   Medisafe ... 1.5 million users across iOS and ... has begun integrating biofeedback into the platform to allow ... health outcomes. For the first time, patients will be ... missing a dose impacts important biometrics, such as glucose ...
(Date:3/30/2015)... and Markets ( http://www.researchandmarkets.com/research/lc9bnl/global_gesture ) has announced ... in Automotive Sector 2014-2018" report to their offering. ... market in Automotive Sector to grow at a CAGR ... recognition is the ability of a device to identify ... recognition technology can be 2D-based or 3D-based. It uses ...
Breaking Biology News(10 mins):Fingerprint Cards Revises Revenues for Q1 2015 2Medisafe Announces Launch of Biometric Integration, Enabling Patients to Stay Adherent to Their Meds and See Tangible Health Results 2Global Gesture Recognition Market in Automotive Sector Report 2015 - Growing Number of Partnerships 2
... by the North Central Cancer Treatment Group (NCCTG) reports that ... recurrent brain cancer slowed tumor growth in more than one-third ... research team also developed a screening technique to help predict ... researchers will present these findings at the 2005 American Society ...
... by camouflage in the same way that humans are deceived, ... idea that bold contrasting colours help to break-up the body's ... as the First World War. And in biology this idea ... insects such as moths conceal themselves from predators, shaping the ...
... Animal geneticist Harvey D. Blackburn is responsible for collecting ... mainly semen and embryos -- to make sure there's ... Much of his collection deals with important livestock such ... of the collections Blackburn, who is the coordinator of ...
Cached Biology News:'Smart drug' targets deadly brain cancer 2'Smart drug' targets deadly brain cancer 3Making Sure Sacred Sheep Don't Become Extinct 2
Includes a choice of any 3 EasySep mouse selection kits and EasySep magnet...
... 1.5mg of purified RNA samples., , This ... of aqueous RNA samples that have been ... phenol/chloroform, silica, oligo dT etc or other ... the necessary components for the stabilization of ...
Human SEAP ORF, provided in a pORF plasmid. pORF is an expression plasmid selectable with Ampicillin....
...
Biology Products: