Navigation Links
AcelRx Pharmaceuticals Reports Second Quarter 2014 Financial Results
Date:8/11/2014

REDWOOD CITY, Calif., Aug. 11, 2014 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain, today reported financial results for the three and six months ended June 30, 2014.  On July 25, 2014, AcelRx announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company's new drug application (NDA) for Zalviso™, (sufentanil sublingual tablet system).  Since the receipt of the CRL, AcelRx has been working on a reply and intends to meet with the FDA to discuss the items contained in the CRL.  

"We were disappointed with the receipt of a Complete Response Letter for Zalviso and we look forward to meeting with the FDA to clarify the items included in the CRL and to discuss our planned response," stated Richard King, president and CEO of AcelRx. "We have spoken to the FDA and plan to meet with them by the end of September 2014.  We anticipate we can refile the Zalviso NDA before the end of 2014, pending the outcome of the meeting with the FDA.  We remain confident in the Zalviso development program and will work closely with the FDA to address the Agency's concerns as outlined in the CRL to ensure that healthcare professionals and patient communities will have access to Zalviso."

The CRL contains requests for additional information on the Zalviso System to ensure proper use of the device.  The requests include submission of data demonstrating a reduction in the incidence of optical system errors, changes to the Instructions for Use for the device to address inadvertent dosing, among other items, and submission of additional data to support the shelf life of the product.  We believe certain of these requests have be
'/>"/>

SOURCE AcelRx Pharmaceuticals, Inc.
Copyright©2014 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9 10 11

Related medicine technology :

1. AcelRx Pharmaceuticals to Participate in Three Upcoming Investor Events
2. AcelRx Pharmaceuticals to Hold Second Quarter Financial Results Conference Call and Webcast on Monday, August 11th, 2014.
3. AcelRx Pharmaceuticals Confirms July 27, 2014 PDUFA Date for Zalviso
4. AcelRx Secures $40 Million Credit Facility with Hercules Technology Growth Capital
5. AcelRx Pharmaceuticals Presents ARX-04 Dose-Finding Phase 2 Study Data at Anesthesia Medical Conference
6. AcelRx Pharmaceuticals Adds New Board Member
7. Annual General Meeting Schedules, New Drug Applications, Positive Study Results, Conference Participations, and Secondary Offerings - Research Report on Mindray, AcelRx, Merrimack, ZELTIQ, and Clovis
8. AcelRx Pharmaceuticals to Present at the 25th Annual Piper Jaffray Healthcare Conference
9. AcelRx Pharmaceuticals Reports Third Quarter 2013 Financial Results
10. AcelRx Pharmaceuticals to Hold Third Quarter 2013 Financial Results Conference Call and Webcast on November 5, 2013
11. David H. Chung Joins AcelRx Pharmaceuticals as Chief Commercial Officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/30/2015)... , June 30, 2015  Today, the National Mobility ... the 2015 National Mobility Awareness Month Local Heroes Contest ... Hero online entries that received 1.3 million votes. The ... , Toyota Mobility , and Valley Honda ... and Vantage Mobility International (VMI) and ...
(Date:6/30/2015)... 2015  Avanir Pharmaceuticals, Inc. today announced top-line ... treatment with NUEDEXTA ® was associated with ... affect (PBA) in patients with traumatic brain injury ... characterized by sudden and uncontrollable outbursts of laughing ... brain injury. PRISM II is a phase IV ...
(Date:6/30/2015)... June 30, 2015  EnteroMedics Inc. (NASDAQ: ETRM ... neuroblocking technology to treat obesity, metabolic diseases, and other ... public offering  of 40,229,886 units. Each unit consists of ... A warrant to purchase one share of common stock, ... one share of common stock, at a purchase price ...
Breaking Medicine Technology:NMEDA Announces National Contest Winners 2NMEDA Announces National Contest Winners 3Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 2Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 3Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 4Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 5Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 6Avanir Pharmaceuticals Announces Positive Top-line Results from Stroke and TBI Cohorts of PRISM II Study 7EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 2EnteroMedics Inc. Announces Pricing of $35.0 Million Public Offering of Common Stock and Warrants 3
... BROOMFIELD, Colo., April 12, 2011 Lanx ® , ... developing and commercializing innovative devices for spinal surgery, today ... (Concero) at the 2011 American Association of Neurological Surgeons ... Concero system is a minimally invasive fixation alternative to ...
... Living Cell Technologies Limited (ASX: LCT; OTCQX: LVCLY), ... implant therapy to treat diabetes, today announced that it ... through a placement of shares to Otsuka Pharmaceutical Factory, ... Otsuka group of companies. For the placement, Otsuka will ...
Cached Medicine Technology:Lanx®, Inc. Announces Launch of Concero™ Facet Screw System for Spinal Fusion 2LCT and Otsuka of Japan Share Common DIABECELL(R) Vision 2LCT and Otsuka of Japan Share Common DIABECELL(R) Vision 3LCT and Otsuka of Japan Share Common DIABECELL(R) Vision 4LCT and Otsuka of Japan Share Common DIABECELL(R) Vision 5
(Date:6/30/2015)... ... June 30, 2015 , ... Bill Howe Plumbing, ... in San Diego. Bill Howe offers all employees ample opportunity for education and ... most notably through the local Plumbing-Heating-Cooling-Contractors of San Diego (PHCC-SD). The San Diego ...
(Date:6/30/2015)... ... , ... Some may define success as the sum of small efforts repeated ... Athletic Trainers’ Association (NYSATA) and its members continue to be acknowledged and applauded by ... number of members also received honors at the national level. , For ...
(Date:6/30/2015)... ... June 30, 2015 , ... The American Psychiatric ... at Disney’s Coronado Springs Resort in Lake Buena Vista, Florida, and will offer ... premiere event for psychiatric-mental health nursing draws more than 1,500 health care professionals ...
(Date:6/30/2015)... ... June 30, 2015 , ... Medflow, the leader in the ... health records system from the company exclusively dedicated to helping eye care professionals ... intuitive state-of-the-art solution combining modern cloud technology with Medflow’s proven expertise in the ...
(Date:6/30/2015)... ... ... Purdy, the spokesperson for Dephinitive Systems LLC, announces today that the company will officially ... eXtra Operability (XO) which was chosen to reflect the company’s commitment to health care ... XO, based in Cleveland OH, is part of the Cadrillion Capital family of Healthcare ...
Breaking Medicine News(10 mins):Health News:Two Local San Diego Plumbers from Bill Howe Plumbing, Inc. Graduate from PHCC Academy 2Health News:Two Local San Diego Plumbers from Bill Howe Plumbing, Inc. Graduate from PHCC Academy 3Health News:NYSATA and Members Recognized with National Awards 2Health News:NYSATA and Members Recognized with National Awards 3Health News:American Psychiatric Nurses Association 29th Annual Conference: Continuing Education and Collaboration in Psychiatric-Mental Health and Nursing 2Health News:American Psychiatric Nurses Association 29th Annual Conference: Continuing Education and Collaboration in Psychiatric-Mental Health and Nursing 3Health News:Medflow Launches MEDFLOW 2.0 EHR – The Cloud-Based Ophthalmology EHR 2Health News:Dephinitive Systems Is Getting a New Name 2
... Still Feel Targeted By Tobacco Advertising and Find It,Easy ... across Kansas will,rally against tobacco on April 2 as ... annual Kick Butts Day, sponsored by the Campaign,for Tobacco-Free ... a list of local events, go to http://www.kickbuttsday.org/events ...
... Still Feel Targeted By Tobacco Advertising & Find It,Easy ... across Florida,will rally against tobacco on April 2 as ... annual Kick Butts Day, sponsored by the,Campaign for Tobacco-Free ... a list of local events, go to, http://www.kickbuttsday.org/events )., ...
... 27 Marshall Erdman &,Associates (Erdman) was ... Healthcare,s" 2008 Construction & Design Survey. The ... industry; it,examines year-over-year sales, contracted square footage ... and number of architects, engineers,and interior designers., ...
... knowledge and building important international relationships is top ... DendriMed Research Director Dr Raisa Monteiro, when she ... in May. , One of two Australian life ... candidates for the prestigious 2008 Advancing BioBusiness Award, ...
... alliances that,lead to increased sales and are mutually ... selection of compatible partners. Companies,that succeed in alliance ... articulating the rationale behind the effort, and then,choosing ... Practices, LLC,s white paper "Generating Value From Strategic,Alliances ...
... Practice Information Management Software Introduces Comprehensive Patient and Information Tracking ... ... Back-Up, DALLAS, March 27 Eklin Medical Systems, a ... Practice Management software for veterinary care,(VIA(R)), is showcasing VIA,s new Hospital ...
Cached Medicine News:Health News:Kansas Kids 'Kick Butts' on April 2 2Health News:Kansas Kids 'Kick Butts' on April 2 3Health News:Florida Kids 'Kick Butts' on April 2 2Health News:Florida Kids 'Kick Butts' on April 2 3Health News:Florida Kids 'Kick Butts' on April 2 4Health News:'Modern Healthcare' Names Marshall Erdman Nation's Top Design-Build Company 2Health News:DendriMed scientist seeks to fast-track success 2Health News:Eklin VIA(R) Showcases Hospitalization Functionality to Veterinary Care Market 2Health News:Eklin VIA(R) Showcases Hospitalization Functionality to Veterinary Care Market 3
The Excel Series from DGH-KOI is an excellent choice for the ophthalmic surgeon performing cataract and other general ophthalmic procedures. With a broad range of blade options and our special Excel ...
New! Visually superior, micrometer handle, single foot plate, blade extends to 3.0 mm....
The new TRC-NW200 Non-Mydriatic Retinal Camera combines Topcons years of experience in retinal imaging with the latest advances in digital and electronic technology....
... ClosureWire Vascular Closure System (VCS) utilizes ... Compression., ,The Boomerang ClosureWire technique creates ... of the arteriotomy and just outside ... targeted internal compression of both the ...
Medicine Products: