Navigation Links
KemPharm Completes Successful End-of-Phase 2 Meeting with FDA
Date:11/1/2013

NORTH LIBERTY, Iowa, Nov. 1, 2013 /PRNewswire/ -- KemPharm, Inc., a clinical stage biopharmaceutical company focused on the discovery and development of new, safer therapies to treat pain, announced today the successful completion of an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) for its lead pain candidate, KP201 (benzhydrocodone hydrochloride and acetaminophen).  Based on the results of the meeting, KemPharm believes the completed and ongoing clinical, non-clinical and CMC development programs will allow for the submission of a New Drug Application (NDA) for KP201 in the third quarter of 2014.

During the meeting, representatives from the FDA reviewed KemPharm's current portfolio of data for KP201, including the recently completed bioequivalence and "steady-state" pivotal clinical studies.  It was determined that the final data package, as proposed by KemPharm, would support a potential 505(b)(2) filing pathway without any additional efficacy, toxicology or safety data being required.

Travis C. Mickle, Ph.D., President and CEO of KemPharm, commented, "The positive feedback we received from the Agency re-affirms prior discussions related to our clinical and non-clinical program for KP201 and our plan to pursue an NDA via the 505(b)(2) pathway. Based on their advice, we are extremely confident in our plan to submit an NDA by the third quarter of 2014 and seek potential approval of the first novel pain therapy of the morphine class to be developed in a number of years with an officially recognized new chemical structure."

KP201 is in development for the treatment of acute moderate to moderately severe pain. Composed of hydrocodone chemically bound to a ligand, KP201 offers unique physicochemical and pharmacological attributes that may deliver additional patient benefits, including reduced potential for abuse and reduction or elimination of opioid-induce
'/>"/>

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

Page: 1 2 3

Related biology technology :

1. KemPharm, Inc. Appoints Gordon K. "Rusty" Johnson as Chief Operating Officer and Chief Financial Officer
2. KemPharms KP201 Featured at the International Conference on Opioids
3. Micropharma completes development of first microbiome clinical lab test using digital PCR technology
4. Syneron Medical Completes and Summarizes the Multi-site Clinical Study Agreed Upon with FDA for the UltraShape Contour I
5. AIS (American Internet Services) Completes Audit for Title 21 CFR Part 11 Compliance
6. Relmada Therapeutics Inc. Completes $8.0 Million Capital Raise In Series A Financing
7. VIVEX BIOMEDICAL Successfully Completes $7.6 Million Round of Financing
8. Boston Scientific Completes $1.05 Billion Senior Notes Offering
9. SureClinical Completes FDA 21 CFR Part 11 Compliance Audit of SureTrial® eTMF Cloud Edition
10. Eurofins MWG Operon Quality Assurance Group Completes ISO Certifications for Their New Overnight Sequencing Lab
11. Oligomerix, Inc. Completes Series B Financing
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/3/2015)... ... July 03, 2015 , ... ... in applications such as animal waste reduction, bioremediation, wastewater treatment, aquaculture and ... settings, announced today that it will be showcasing, ManureMagic™, its industry-leading product ...
(Date:7/3/2015)... 3, 2015 Forskare ... 2015 på  http://www.openinnovationinscience.at till det återkommande ... som hålls i Wien ... med internationella forskare och vetenskapsmän som genomfördes ... två största utmaningar bristen på incitament för ...
(Date:7/2/2015)... ... July 03, 2015 , ... Cuvettes have been used in countless labs for decades. ... find the cuvette they needed. As expected, this was a daunting and tiring process ... part because they were not able to navigate the complex catalog structure. , Now thanks ...
(Date:7/2/2015)... ... July 02, 2015 , ... Sleepless nights will become obsolete as Luzi ... its Indiegogo campaign on June 23. Sound sleepers and the sleep deprived both will ... to use, while the integration of the Bluetooth speaker, alarm clock and ability to ...
Breaking Biology Technology:DryLet to Highlight Benefits of Patented ManureMagic™ at North American Manure Expo in Chambersburg, PA July 14-15, 2015 2Lansering av världens första program för öppen innovation för att utbilda forskare 2Lansering av världens första program för öppen innovation för att utbilda forskare 3New Cuvette E-Commerce Website Launched by FireflySci 2Luzi Smart Lamp Recently Launched Indiegogo Campaign 2Luzi Smart Lamp Recently Launched Indiegogo Campaign 3
... CMC Biologics, a leading biopharmaceutical contract manufacturing ... US 2,171,034 B1 covering a method for improving ... bioreactors. The invention is designed to optimize production ... process, wherein the bioreactor (fermenter) has an ultrafiltration ...
... 5, 2012  ZyGEM Corp. Ltd., a developer and ... DNA and other nucleic acids, and the US ... today announced the signing of a Cooperative Research ... simplified sample processing solutions for biothreat agents.  The ...
... smaller and smaller, flirting with new devices at the ... of our technology is reaching an end. Without an ... will stop. One promising alternative is graphene the ... a semiconductor, but it can be altered to display ...
Cached Biology Technology:CMC Biologics Strengthens its Innovative Biomanufacturing Technology Portfolio in Continuous Perfusion Systems 2ZyGEM and USAMRIID Sign CRADA for Development of Simplified Sample Processing Solutions for Biothreat Agents 2ZyGEM and USAMRIID Sign CRADA for Development of Simplified Sample Processing Solutions for Biothreat Agents 3'Nanowiggles:' Scientists discover graphene nanomaterials with tunable functionality in electronics 2'Nanowiggles:' Scientists discover graphene nanomaterials with tunable functionality in electronics 3
(Date:6/17/2015)... June 17, 2015  Crossmatch™, a leading provider ... its U.are.U ® 4500 fingerprint readers have ... Eateries, Inc., a San Jose, CA ... increase security, improve accountability and reduce fraud at ... non-repudiable identity confirmation for employee sign in and ...
(Date:6/15/2015)... According to a new market research report ... Hybrid), Technologies (Recognition, IVR, OCR, Pattern & Image Recognition) ... Natural Language Processing Market is expected to grow to ... forecast period 2015-2020. Browse 65 market ...   through 155 P ages and in-depth TOC ...
(Date:6/10/2015)... According to a new ... (Ultrasound, TOF, Structured Light, Stereo Vision), Type(Image, Position, ... by Geography - Trends & Forecast to 2014 ... expected to reach $3,319.71 Million by 2020, growing ... 2020. Browse 71 market data tables ...
Breaking Biology News(10 mins):Togo's Eateries Improve Security and Accountability with Crossmatch Fingerprint Readers 2Togo's Eateries Improve Security and Accountability with Crossmatch Fingerprint Readers 3Natural Language Processing Market Worth $13.4 Billion by 2020 2Natural Language Processing Market Worth $13.4 Billion by 2020 3Natural Language Processing Market Worth $13.4 Billion by 2020 4Natural Language Processing Market Worth $13.4 Billion by 2020 53D Sensor Market Worth $3,319.71 Million by 2020 23D Sensor Market Worth $3,319.71 Million by 2020 33D Sensor Market Worth $3,319.71 Million by 2020 4
... may not be the answer to mitigating climate change by ... to an international team of plant biologists. The researchers found ... fungi (AMF) -- a type of fungus that is often ... then leads to higher decomposition rates of organic materials, said ...
... the methane on Earth comes from the ocean,s oxygen-rich waters, ... this potent greenhouse gas. Now researchers report that they have ... the most abundant microbes on the planet. The findings ... who made the discovery did not set out to explain ...
... part of the marine ecosystem, fostering biodiversity and protecting ... with pollution and harmful fishing practices, are one of ... One of the solutions to the crisis ... Tel Aviv University,s Department of Molecular Microbiology and Biotechnology, ...
Cached Biology News:Plants' fungi allies may not help store climate change's extra carbon 2Study identifies prime source of ocean methane 2Study identifies prime source of ocean methane 3Viruses could be the key to healthy corals 2
With L-glutamine and potassium bicarbonate. Sterile, Insect cell culture tested...
Mol wt: average mol wt12,360.96 Da by calculation...
Originally developed for the culture of Drosophila; suitable for culture of other dipteran cell lines. Powder, Insect cell culture tested...
... The LIC Duet™ GST•Tag™ Ek Adaptor encodes ... ribosome binding site (rbs), ATG translation initation ... The GST•Tag sequence has been reported to ... the solubility of its fusion partners. The ...
Biology Products: