Navigation Links
Innocoll Announces Successful End-of-Phase 2 Meeting with FDA for XaraColl® and Agreement of the Phase 3 Program
Date:2/17/2012

ASHBURN, Va., Feb. 17, 2012 /PRNewswire/ -- Innocoll, Inc. announced that it has held an End-of-Phase 2 meeting with the FDA to present the results of the Phase 2 clinical studies completed for XaraColl® and to discuss the proposed safety and efficacy studies to be conducted in Phase 3. XaraColl® is being developed for postoperative analgesia and Innocoll plans to undertake its Phase 3 program in patients undergoing hernia repair. FDA agreed to the Phase 3 clinical studies that Innocoll proposed and confirmed that, if successful, those studies should be sufficient to support a future NDA submission.   

Commenting on the announcement, Dr. Michael Myers, Innocoll's President and CEO said, "We are pleased to announce yet another significant milestone for Innocoll.  With the recent EU approval of  CollaGUARD® Adhesion Barrier and with Cogenzia®, for diabetic foot infections, also ready to start Phase 3, Innocoll's portfolio of late stage assets is stronger than ever."  

About XaraColl®

XaraColl® is a biodegradable and fully resorbable collagen/bupivacaine matrix formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx®. This technology achieves a high concentration of drug at the target tissue, while maintaining low systemic levels.  XaraColl® is intended to provide pain control directly at the surgical site and thus reduce the level of additional analgesia required following surgery.  The product is available in several different strengths, and is designed such that multiple units can be used per patient, for optimum dosing flexibility and efficacy.  XaraColl® is easy to use and can be cut or rolled depending on the surgical setting and can be used laparoscopically. 

About Innocoll, Inc.

Innocoll is a privately held, biopharmaceutical company focused on biodegradable surgical implants and topically applied healthcare products. The company develops and manufactures a range of pharmaceutical products and medical devices using its proprietary collagen-based technologies, CollaRx®, CollaFilm®, DermaSil™, CollaPress™ and Liquicoll®. Approved products based on the Company's technologies include: Collatamp® G, Septocoll®, CollaGUARD®, Collieva®, CollaCare®, Collexa®, Zorpreva™, and LidoColl®.

Other products in clinical and regulatory development include: CollaRx® Gentamicin Surgical Implant in phase 3 for prevention of surgical wound infections and Cogenzia® in phase 3 for the adjuvant treatment of infected diabetic foot ulcers.  For more information, please visit www.innocollinc.com.


'/>"/>
SOURCE Innocoll, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Innocoll Announces Appointment of Anthony H. Wild Ph.D. to Chairman of the Board
2. Innocoll Announces Provisional Findings From Its Three Phase 2 Clinical Trials Investigating CollaRx(R) GENTAMICIN TOPICAL for the Treatment and Prevention of Diabetic Foot Infections
3. Innocoll, Inc. Files 510 (k) Application for CollaRx Lidocaine Sponge
4. Baxter Announces Licensing Agreement for Innocolls Gentamicin Surgical Implant in the United States
5. Neuralstem Announces Closing of $5.2-Million Registered Direct Offering
6. Regeneron Announces Presentation at the Leerink Swann 2012 Global Healthcare Conference
7. Silence Therapeutics Announces Board Changes and Appointment of New Chief Executive Officer
8. Genomic Health Announces Year-End 2011 Financial Results, Provides 2012 Financial Outlook
9. Auxilium Announces Appointments to Enhance Leadership Team
10. Spherix Announces Registered Direct Offering of $1.15 Million
11. Sangamo BioSciences Announces Fourth Quarter and Full Year 2011 Conference Call and Webcast
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... 2016 , ... FireflySci has been manufacturing quartz and glass ... the globe. Their cute firefly logo has been spreading to more and more ... calibration standards that never require recalibration. These revolutionary standards have changed many ...
(Date:5/25/2016)... ... May 25, 2016 , ... The American Medical Informatics Association ... the National Coordinator for Health IT (ONC) outlining a measurement approach to interoperability ... available when and where it was needed. The organization of health informatics professionals ...
(Date:5/24/2016)... ... May 24, 2016 , ... Cell therapies for a ... accelerated by research at Worcester Polytechnic Institute (WPI) that yielded a newly patented ... regeneration. , The novel method, developed by WPI faculty members Raymond Page, PhD, ...
(Date:5/23/2016)... Willoughby, Ohio (PRWEB) , ... May 23, 2016 ... ... Six Trends That Will Drive Precision Farming in 2017 and Beyond. The paper ... and practitioners in the precision ag industry. , “We’ve witnessed a lot of ...
Breaking Biology Technology:
(Date:4/26/2016)... Research and Markets has announced ... 2016-2020"  report to their offering.  , ,     (Logo: ... analysts forecast the global multimodal biometrics market to ... period 2016-2020.  Multimodal biometrics is being ... the healthcare, BFSI, transportation, automotive, and government for ...
(Date:4/15/2016)... 15, 2016 Research and ... Biometrics Market 2016-2020,"  report to their offering.  , ... , ,The global gait biometrics market is expected ... the period 2016-2020. Gait analysis generates ... be used to compute factors that are not ...
(Date:3/31/2016)... RATON, Florida , March 31, 2016 ... LEGX ) ("LegacyXChange" or the "Company") ... for potential users of its soon to be launched ... video ( https://www.youtube.com/channel/UCyTLBzmZogV1y2D6bDkBX5g ) will also provide ... the use of DNA technology to an industry that ...
Breaking Biology News(10 mins):