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:9/30/2014)... (PRWEB) September 30, 2014 The custom ... ISPE Boston Product Show 2014. The Boston Area Chapter ... the 23rd annual, day-long event for Wed., Oct. 1 ... promises to be the largest in ISPE Boston’s long ... upward of 3,000 attendees expected. , HOLLOWAY AMERICA ...
(Date:9/30/2014)... 30, 2014 UFP Technologies, a ... packaging has recently introduced a custom insulated shipping ... . The new insulated shipper solves the issue ... process. UFP Technologies’ BioShell is a universal storage ... storage, handling and shipping. The insulated shipper keeps ...
(Date:9/29/2014)... Medical imaging is at the forefront of diagnostics ... imaging), CT (computerized tomography), scanning, and NMR (nuclear ... decades. However, persisting problems of image resolution and ... nature of living tissue. A solution is hyperpolarization, ... can increase imaging quality by following the distribution ...
(Date:9/29/2014)... diseases and biodiversity loss requires evolutionary thinking, argues ... Express that was co-authored by Bruce Tabashnik ... and Life Sciences. , For the first time, ... progress in addressing a broad set of challenges ... that consider evolutionary histories and the likelihood of ...
Breaking Biology Technology:HOLLOWAY AMERICA to Exhibit at ISPE Boston Product Show 2014 2HOLLOWAY AMERICA to Exhibit at ISPE Boston Product Show 2014 3UFP Technologies Introduces Insulated Shipping Container For Bulk Drug Transportation 2UFP Technologies Introduces Insulated Shipping Container For Bulk Drug Transportation 3A safer approach for diagnostic medical imaging 2A safer approach for diagnostic medical imaging 3Evolutionary biology: It's not just for textbooks anymore 2Evolutionary biology: It's not just for textbooks anymore 3
... May 4, 2011 Bacterin International Holdings, Inc. ("Bacterin") (NYSE ... graft material, today announced that its chairman and CEO, Guy ... Annual Equity Conference at the Hard Rock Hotel in Hollywood, ... At the time of the presentation, a live ...
... Neb., May 4, 2011 Transgenomic, Inc. (OTC/BB: ... Brugada Syndrome (BrS) test panel at the 2011 Heart Rhythm ... of 9 genes and broadens the test indication to include ... "The addition of two newly identified J-wave syndrome genes, ...
... May 4, 2011 NxStage Medical, Inc. (Nasdaq: ... products, today reported financial results for the first quarter ... above the top end of its guidance range. ... quarter of 2011 increased 25 percent to a record ...
Cached Biology Technology:Bacterin International to Present at Noble Financial Capital Markets' Seventh Annual Equity Conference on May 16, 2011 2Transgenomic, Inc. Enhances FAMILION® Genetic Test Offerings 2Transgenomic, Inc. Enhances FAMILION® Genetic Test Offerings 3Transgenomic, Inc. Enhances FAMILION® Genetic Test Offerings 4NxStage® Reports Record Revenue for the First Quarter of Fiscal 2011 2NxStage® Reports Record Revenue for the First Quarter of Fiscal 2011 3NxStage® Reports Record Revenue for the First Quarter of Fiscal 2011 4NxStage® Reports Record Revenue for the First Quarter of Fiscal 2011 5NxStage® Reports Record Revenue for the First Quarter of Fiscal 2011 6NxStage® Reports Record Revenue for the First Quarter of Fiscal 2011 7
(Date:9/30/2014)... . , Animals ... such as exposure to predators. Researchers from the Max ... study on different populations of great tits that risk-taking ... High metabolic rates and low temperatures were associated with ... more likely to approach potential predators. , The readiness ...
(Date:9/30/2014)... who suffer from asthma may think there,s not a ... properly taking medications and avoiding allergic triggers. , ... of Allergy, Asthma and Immunology , the scientific publication ... (ACAAI), asthma sufferers can learn lessons about managing their ... the Annals article improved her asthma once she and ...
(Date:9/29/2014)... confirms that the exposure to tar tended to be ... cigarettes. Similarly, exposure to nicotine tended to be ... of cigarette in several countries around the world. Previous ... chemicals in the smoke of these cigarettes are lower ... of chemicals in the smoke are not necessarily linked ...
Breaking Biology News(10 mins):Risky metabolism 2Asthma symptoms kicking up? Check your exposure to air pollution 2Slim cigarette smokers not exposed to more harmful chemicals 2
... sinister about epilepsy: the disease affects the very core ... lead to seizures throughout the body or in parts of ... possible. The causes are still only partially understood but ... or metabolic diseases have been implicated. Epilepsy is not ...
... February 1, 2013 Poor impulse control contributes ... rewarding substances, like food, alcohol, and other drugs. ... FDA-approved medications for alcoholism, like naltrexone (Revia) and ... by curbing cravings and creating unpleasant reactions to ...
... levels of greenhouse gases, particularly carbon dioxide (CO2), ... fuels, deforestation, cultivation of grasslands, drainage of the ... shifts in climate patterns have led scientists to ... and to develop methods to evaluate how changes ...
Cached Biology News:Cats and humans suffer from similar forms of epilepsy 2If you are impulsive, take modafinil and count to 10 2New protocol recommendations for measuring soil organic carbon sequestration 2New protocol recommendations for measuring soil organic carbon sequestration 3New protocol recommendations for measuring soil organic carbon sequestration 4
Recorder REC-111 single-channel, 1. Category: Chromatography Systems & Accessories, Systems....
For the quantitative determination of cyclic AMP (cAMP) concentrations in cell culture supernates, serum, plasma, saliva, urine and cell lysates....
... Wide Range CRYETTE WR Cryoscope for molecular weight determinations for petroleum-based applications. Multiple solvents ... cyclohexanol, sulfolane. ... ... ...
... For the ultimate in utility and ... to meet the needs of the researcher. ... interior dimensions or as sheet material that ... enclosures. These isolators are autoclavable and non-cytotoxic ...
Biology Products: