Navigation Links
King and Pain Therapeutics Announce REMOXY(R) NDA Update
Date:7/7/2009

BRISTOL, Tenn. and SAN MATEO, Calif., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY(R) NDA and to address all FDA comments in the Complete Response Letter.

King now anticipates the resubmission of the NDA could occur mid-year 2010. The Company believes the rate-limiting step is the generation of six-month stability data, and no new clinical trials are required. King remains committed to the development and commercialization of REMOXY(R), and looks forward to working closely with the FDA toward approval of the product.

About REMOXY(R)

REMOXY, an investigational drug, is a unique, long-acting oxycodone formulation for moderate-to-severe chronic pain designed to reduce potential risks of unintended use. In mid-2008, an NDA for REMOXY was accepted by the FDA and was granted Priority Review. In December 2008, Pain Therapeutics received a Complete Response Letter from the FDA. Subsequent to the receipt of the Complete Response Letter, King assumed full control of all activities related to the development of REMOXY(R).

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangement
'/>"/>

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

0

GOOD

Page: 1 2 3

Related biology technology :

1. Cell Therapeutics Added to Russell 3000(R), Russell 2000(R) and Russell Global(R) Indexes
2. Yaupon Therapeutics Completes Patient Enrollment for Pivotal Phase 2 Study of Clearazide for Treatment of Cutaneous T-cell Lymphoma
3. Horizon Therapeutics Names Dr. Jeffrey W. Sherman Executive Vice President and Chief Medical Officer
4. PTC Therapeutics Receives $2.6 Million in Government Grants
5. Cell Therapeutics on Preliminary List of Additions to Russell 3000(R) Index and Russell Global(R) Index
6. Nektar Therapeutics Promotes Lorianne Masuoka, M.D. to Chief Medical Officer
7. CSL Limited and Talecris Biotherapeutics Agree to Terminate Merger Agreement
8. Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions
9. Orexigen(R) Therapeutics Presents Additional NB-302 Contrave(R) Data at American Diabetes Association (ADA) 69th Scientific Sessions
10. Tobira Therapeutics Inc. Announces Key Addition to Scientific Advisory Board
11. PeriCor Therapeutics Reports Positive Preclinical Results of GP531 at the European Heart Failure Congress in Nice

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/1/2009)... 1 Harvest Technologies Corp. ( ww...he company sponsored 60-patient clinical trial con...i, India using the company,s BMAC System to treat ...chemia (CLI). Sri Ramachandra Medical Center is a ...on based in Chennai, India and one of the largest ...
(Date:12/1/2009).... 1 Expanding its European reach f...Sarasota has appointed Lake Chemicals and Minerals...ed near Birmingham, England. ,, Osprey breeds ...gricultural, waste water, and environmental market...drain fields, and clean up industrial and marine s...
(Date:12/1/2009)... Inc. today announced a collaborative research agr...ed at evaluating EpiVax’s proprietary Tregit...rimental immune responses to certain drugs. In the...Vax Tregitope technology will be evaluated for its...utics. , (Vocus) December...
(Date:12/1/2009)...EACH, California and AMSTERDAM, December 1 /PRNews...er diagnostics, announced today that,Palmetto GBA,...stablished,coding guidelines for the company,s Mam...breast cancer recurrence test, which has been reim...cross the United States can now submit claims for ...
Breaking Biology Technology:Harvest Technologies Announces Trial Results in its India Study Using BMAC to Treat Patients With Non-Reconstructable Critical Limb Ischemia 2Harvest Technologies Announces Trial Results in its India Study Using BMAC to Treat Patients With Non-Reconstructable Critical Limb Ischemia 3EpiVax, Inc. forms Collaborative Research Agreement with Roche to Develop Tregitope Technology 2EpiVax, Inc. forms Collaborative Research Agreement with Roche to Develop Tregitope Technology 3Medicare Administrator Establishes Reimbursement Coding Policy for Agendia's Breast Cancer Recurrence Test MammaPrint(R) 2
...ams give sponsors easy-to-use tools to store, mine...rollment success, NEWTON, Mass., June 23 Today, ...ogy leader, announced the release of a new,product...cure, Web-based,infrastructures that support in-ho...onsors. The goal is to standardize work flow and m...
...ased Biorepositories Event for the Pharmaceutical ... INDIANAPOLIS, June 23 BioStorage Technologies, I...erials storage, sample,management and cold chain l... of Institute for International Research,s (IIR) i... event for the pharmaceutical and,biotech industri...
...enhance industry leader,s dermatological portfolio...es Inc.,the world,s largest independent pharmaceut...nounced it has signed a definitive merger agreemen...ire Barrier Therapeutics,Inc. ("Barrier Therapeuti...ion, a tender offer followed by a merger of Barrie...
Other Biology Technology:TCN e-Systems Offers Trial Sponsors Solutions for Creating In-House Center of Excellence in Patient Recruitment 2TCN e-Systems Offers Trial Sponsors Solutions for Creating In-House Center of Excellence in Patient Recruitment 3TCN e-Systems Offers Trial Sponsors Solutions for Creating In-House Center of Excellence in Patient Recruitment 4BioStorage Technologies Announces Platinum Sponsorship of Biorepositories 2008 2Barrier Therapeutics to Merge Into Stiefel Laboratories 2Barrier Therapeutics to Merge Into Stiefel Laboratories 3Barrier Therapeutics to Merge Into Stiefel Laboratories 4Barrier Therapeutics to Merge Into Stiefel Laboratories 5
(Date:12/2/2009)...OKEN - A team comprised of undergraduate students ...op honors in a national poster contest hosted by t...ering (ISPE). , The annual contest highlights th...last month at the ISPE Annual Meeting in San Diego...n of a Posterior Criciate Ligament Tensioning Devi...
(Date:12/2/2009)... Manpei Suzuki Diabetes Foundation is pleased to a...: Donald F. Steiner, MD, A. N. Pritzker Distinguis...icine and Biochemistry and Molecular Biology, The ...ugurated in 2008 to commemorate the 15th anniversa...ing those who have enlightened researchers in the ...
(Date:12/2/2009)... , REDWOOD SHORES, Calif. and PALM HA...nication Intelligence Corporation ("CIC") (OTC Bul...ic signature solutions for business process automa... leader** in biometric signature verification and ...rnational Electronic Document Management (EDM) sof...
Breaking Biology News(10 mins):CIC Teams with Docubase Systems to Deliver eSignature Enabled Document Management Solutions 2CIC Teams with Docubase Systems to Deliver eSignature Enabled Document Management Solutions 3CIC Teams with Docubase Systems to Deliver eSignature Enabled Document Management Solutions 4Blue Cross Blue Shield of Michigan Concludes Autism Lawsuit with Settlement Focused on Families Who Received Early Intervention Services Not Attorney 49528 1Blue Cross Blue Shield of Michigan Concludes Autism Lawsuit with Settlement Focused on Families Who Received Early Intervention Services Not Attorney 49528 2Lure of Bottled Water May Not Be Health Driven 49525 1Vets Who Repress Traumatic Memories May Not Be Worse Off 49520 1Vets Who Repress Traumatic Memories May Not Be Worse Off 49520 2Vets Who Repress Traumatic Memories May Not Be Worse Off 49520 3Vets Who Repress Traumatic Memories May Not Be Worse Off 49520 4
...ients miserable and debilitated with chronic itchi...ed by the disease face possible paralysis or damag...ustrates doctors because there,s no effective trea...ied more than a decade ago. Currently little can b... than cystic fibrosis, hereditary muscular dystrop...
...al genome sequence was published. Now, nearly 200 ...ne hits the scientific press most weeks. This burg...ecting,?however. Having all these genome sequences...cause human disease, how to control their spread, ... comparing genome sequences, scientists can learn ...
...ed that its researchers have confirmed the presenc...icroorganisms ("microbial consortium") in substrat...te oilfield located in North Eastern Utah. This si...obioreactorsTM" that Luca Technologies has identif...on in the Powder River Basin coalfields of Wyoming...
Other Biology News:Potential treatments for neurofibromatosis 2Potential treatments for neurofibromatosis 3Multiple Campylobacter Genomes Sequenced 2LUCA technologies confirms real-time methane generation 2LUCA technologies confirms real-time methane generation 3
SmartScan Solo from ABgene
Fluoroskan Ascent FL, 100-240 V, one dispenser from Thermo Scientific
...s a hydrolytic enzyme that catalyzes the conversio...otriose and,dextrins. The level of a-amylase in va...ortance,1-3 while plant and microbial,a-amylases a...mylase Assay Kit (E-11954) provides the,speed, hig...
...safety cabinets Heraeus HERAsafe KS convince with ...orientated design. ,The new frameless slanted win...e new front window design makes it easy to work in... height of more than 250 mm ensures ease of handli...
Biology Products: