Navigation Links
KemPharm Supports Recent FDA Recommendations for Hydrocodone-Containing Compounds and Abuse-Deterrent Opioids
Date:2/14/2013

positive change.  This is KemPharm's rationale for developing KP201.
Benzhydrocodone, which is chemically different from hydrocodone, has demonstrated the potential to reduce drug abuse and diversion as well as prevent opioid-induced constipation (OIC), while maintaining the same pain relieving effects of current market leading drugs."

KP201 is in development for the treatment of acute moderate to moderately severe pain with a new drug application (NDA) expected to be filed in Q2 2014.  Recently assigned the nonproprietary name, "benzhydrocodone," by the United States Adopted Name (USAN) Council, KP201 represents the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure. 

About KP201
KemPharm's most advanced opioid-based drug candidate, KP201, is composed of hydrocodone chemically bound to a ligand.  The Company previously reported positive Phase 1 clinical data, which confirmed that KP201 is metabolized in man as predicted, releasing hydrocodone into the bloodstream at amounts equivalent to the reference listed drug, Norco®.  This data supports a 505(b)(2) regulatory pathway for KP201 in combination with acetaminophen. 

KP201 has unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induced constipation (OIC).  Importantly, intact KP201 was not detected in systemic circulation, suggesting that minimal additional studies could be justified to determine the impact of KP201 exposure in the body. 

KemPharm has worked diligently with its manufacturing partner, Johnson Matthey , to successfully and efficiently scale up KP201 active pharmaceutical ingredient (API) in anticipation of a commercial launch.  KP201 is on track for an NDA submissi
'/>"/>

SOURCE KemPharm, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. National Patient Advocate Foundation Supports 340B Drug Discount Program Review Identifying Risks to Underinsured Patients
2. Varian Medical Systems Supports Program to Tap Brain Power of Research and Development Community in Russia
3. Ameritox Leadership Supports Lawmakers, Pain Practitioners and Patients Confronting Crisis in Pain Medication Abuse
4. US Patent Granted to RBC Life Sciences for Supplement that Supports Cognitive Function
5. Amgen Backs States Efforts To Enact Biosimilar Legislation That Allows For Substitution And Supports Patient Safety
6. Novo Nordisk Supports Four San Francisco-based Organizations In Fight Against Diabetes
7. JAMA Study Demonstrates Efficacy of Life Technologies Lung Cancer Test in Detecting Early Metastases, Supports Screening for Lung Cancer
8. H. D. Smith Supports Local Hospitals, Nursing Homes, Clinics And Independent Retail Pharmacies Throughout Hurricane Sandy
9. Reproductive Medicine Associates of New York supports the ASRM endorsement of Oocyte Cryopreservation
10. Amgen Supports Assistance for Patients Affected by Hurricane Sandy
11. With Special Edition "Think Pink" Hearing Aids, The Atlanta Hearing Doctor Supports Breast Cancer Research and Better Hearing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/1/2015)... LAVAL, Quebec , April 1, 2015 ... Salix "), a wholly owned subsidiary of Valeant Pharmaceuticals ... that it today provided a Notice of Fundamental Changes, ... Notice, Notice of Execution of Supplemental Indenture and Offer ... its 1.5% Convertible Senior Notes due 2019 (the " ...
(Date:4/1/2015)... BEDFORD, Mass. , April 1, 2015  Hologic, ... has notified holders of the 2.00% Convertible Exchange Senior ... 23, 2010, and Wilmington Trust Company, the trustee, paying ... are eligible to convert the notes.  This conversion right ... governing the notes dated as of December 10, 2007, ...
(Date:4/1/2015)...  The first national study to look at ... attention-deficit/hyperactivity disorder (ADHD) among children ages 4-17 shows ... ADHD were receiving behavioral therapy in 2009-2010 . ... (CDC) study, "Treatment of Attention-Deficit/Hyperactivity Disorder among Children ... The Journal of Pediatrics provides a ...
Breaking Medicine Technology:Salix Provides Notice of Fundamental Changes, Make-Whole Fundamental Changes and Merger Event Relating to Its 1.5% Convertible Senior Notes Due 2019 2Salix Provides Notice of Fundamental Changes, Make-Whole Fundamental Changes and Merger Event Relating to Its 1.5% Convertible Senior Notes Due 2019 3Salix Provides Notice of Fundamental Changes, Make-Whole Fundamental Changes and Merger Event Relating to Its 1.5% Convertible Senior Notes Due 2019 4Salix Provides Notice of Fundamental Changes, Make-Whole Fundamental Changes and Merger Event Relating to Its 1.5% Convertible Senior Notes Due 2019 5Salix Provides Notice of Fundamental Changes, Make-Whole Fundamental Changes and Merger Event Relating to Its 1.5% Convertible Senior Notes Due 2019 6Salix Provides Notice of Fundamental Changes, Make-Whole Fundamental Changes and Merger Event Relating to Its 1.5% Convertible Senior Notes Due 2019 7Hologic Delivers Notice that Holders of 2.00% Convertible Exchange Senior Notes Due 2037 are Eligible to Convert 2CDC publishes first national study on use of behavioral therapy, medication and dietary supplements for ADHD in children 2CDC publishes first national study on use of behavioral therapy, medication and dietary supplements for ADHD in children 3CDC publishes first national study on use of behavioral therapy, medication and dietary supplements for ADHD in children 4
... www.ecardio.com ) announces three executive appointments in an effort to ... patients they serve. "The continued growth that eCardio ... an opportunity to expand the roles of three members of ... Executive Officer. Robert Jordan, Executive Vice President, will ...
... 2011 Inovio Pharmaceuticals, Inc. (NYSE Amex: ... and preventive vaccines against cancers and infectious diseases, announced ... and electroporation delivery technology at the 14th Annual Meeting ... to be held May 18-21 in Seattle, Washington at ...
Cached Medicine Technology:Inovio Pharmaceuticals to Present at American Society of Gene & Cell Therapy Annual Meeting May 18 - 21, 2011 2Inovio Pharmaceuticals to Present at American Society of Gene & Cell Therapy Annual Meeting May 18 - 21, 2011 3Inovio Pharmaceuticals to Present at American Society of Gene & Cell Therapy Annual Meeting May 18 - 21, 2011 4
(Date:4/1/2015)... This year for Oral Cancer Awareness Month, Herald Square ... Open House to offer complimentary oral cancer screenings on Wednesday, ... appointment is required and can be secured by calling their ... addition, Herald Square Dental and The Denture Center are performing ... at the reduced cost of $39 (regularly $78). Half of ...
(Date:4/1/2015)... NTOCC today launches the Knowledge & ... that seek to improve care transitions and positively impact ... to bring light to tools or resources that align ... the healthcare industry through the promotion of public policy, ... Following that vision, the Knowledge & Resource Center serves ...
(Date:4/1/2015)... The panel session will look at the ... build a program that can grow in a privacy-friendly ... down the line. This topic has taken on even ... OBD-II port dongles aren’t as secure as the automobile ... reported that Progressive’s Snapshot dongles contained very significant security ...
(Date:4/1/2015)... 2015 After a particularly harsh winter, many ... can lead to costly damage, so Amica Insurance ... sharing the following suggestions from AAA: , , ... be inflated to the manufacturer’s recommended levels. , ... vibration and uneven tire wear can be signs of bad ...
(Date:4/1/2015)... 01, 2015 Baby Bellies & Beyond ... latest information on the top products and services to ... Guinness World Records title for "Mommy Moments” - the ... 1st annual Baby Bellies & Beyond Expo Orlando on ... Guinness World Record will commence at 11:00am with actual ...
Breaking Medicine News(10 mins):Health News:Herald Square Dental Celebrates Oral Cancer Awareness Month 2Health News:National Transitions of Care Coalition Launches Knowledge & Resource Center 2Health News:National Transitions of Care Coalition Launches Knowledge & Resource Center 3Health News:TU-Automotive: Office of The Privacy Commissioner of Canada To Set Out Privacy Considerations Surrounding UBI Products 2Health News:TU-Automotive: Office of The Privacy Commissioner of Canada To Set Out Privacy Considerations Surrounding UBI Products 3Health News:Prepare for potholes with 7 tips from Amica Insurance 2Health News:Baby Bellies & Beyond Attempts To Break Guinness World Records For “Mommy Moments” Largest Gathering Of Pregnant Women April 19 Outside Florida Hotel & Conference Center 2Health News:Baby Bellies & Beyond Attempts To Break Guinness World Records For “Mommy Moments” Largest Gathering Of Pregnant Women April 19 Outside Florida Hotel & Conference Center 3
... students gathered for a live chat with Indian American astronaut ... she spoke from her zero-gravity// home among the stars, her ... they had only read about in books before. ... speak with three astronauts at the same platform - Sunita ...
... turn the state free of kalaazar, a fly-borne fatal parasitic ... government has formed a special task force, to be headed ... disease. ,Kalaazar has spread to 31 of the ... people, government sources said. ,‘We have set 2010 ...
... a probe into news reports that hospital equipment worth Rs.50 ... in the Kochi port for three years. ,Sreemathi ... M. Anirudhan, a US-settled businessman who won an award at ... New Delhi. , ,Anirudhan disclosed that he had sent ...
... doctor working in Britain's National Health Service (NHS) was arrested ... a 75-year-old patient//. ,Vijay Anand Harikrishnan, 27, was ... died in Sunderland Royal Hospital in September. Morris was left ... last year., ,But he made a remarkable recovery and ...
... be published in the January issue of the international ... in Philadelphia// report on a seemingly healthy 55-year-old man ... chest pain. Unexplained chest pain after a heart ... think. ,Once he was admitted to the ...
... beans may prove to be successful in fighting the ... cancer researcher Matthew Burow. ,Burow tested the ... breast cancer tumors that are stimulated by the hormone ... the tumors by interfering with the tumor’s ability to ...
Cached Medicine News:Health News:Indian Students Thrilled to Talk to Sunita Williams 2Health News:Jefferson Physicians Report on Potentially Fatal Complication of Heart Attack 2
Heavy. 7.5 mm curved tip....
Delicate Desmarres lid retractors, round serrated handle, very thin blades, polished finish, size 1....
Size 4 - 2.25 mm...
... The Catalyst system introduces a ... precision to microsurgical instrumentation. It ... digital design with advanced microcomputer ... simple to operate with a ...
Medicine Products: