Navigation Links
Adynxx Completes Patient Enrollment in Phase 2 Clinical Study of Lead Therapeutic for Prevention of Pain, AYX1
Date:9/5/2013

SAN FRANCISCO, Sept. 5, 2013 /PRNewswire/ -- Adynxx, a clinical-stage pharmaceutical company developing a transformative, first-in-class platform of therapeutics to address pain at its molecular roots, announced today the completion of enrollment in a Phase 2 clinical study of its lead product candidate, AYX1, for reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery.  The U.S. Food and Drug Administration (FDA) granted Fast Track designation to AYX1 Injection for the prevention of chronic pain in July 2013.

The 102-subject, seven-center, randomized, placebo-controlled study is currently evaluating the safety and efficacy of a single intrathecal administration of AYX1 given prior to unilateral total knee arthroplasty (TKA) to reduce acute pain and to prevent the transition to persistent pain. The study is following subjects for 42 days, with a primary endpoint of pain with walking. Secondary and exploratory endpoints include pain at rest, pain with knee range of motion, rate and extent of functional recovery, opioid consumption and safety assessments. Further details of the study can be found at www.clinicaltrials.gov using the identifier NCT01731730.

"We believe AYX1 has the potential to revolutionize the treatment of post-surgical pain, and we are pleased to have efficiently and successfully completed enrollment in this Phase 2 study," said Donald Manning, M.D., Ph.D., chief medical officer of Adynxx. "With enrollment complete, we look forward to receiving and evaluating the study data in the next quarter and continuing to advance through development."

Dennis Podlesak, chairman of the Adynxx board of directors, added, "As evidenced by the recent Fast Track designation of AYX1, this treatment could potentially provide physicians with a transformative new option for pain management. The rapid progress made by the Adynxx team brings AYX1 one step closer to meeting the needs of millions of patients who every year suffer from pain after surgery."

About Adynxx

Adynxx, located in San Francisco, California, is a clinical-stage pharmaceutical company developing a transformative technology platform addressing pain at its molecular roots - preventing the development of pain following surgery or trauma and resolving established chronic pain syndromes.  Adynxx's unique approach is to transform pain management by approaching pain as a disease rather than a symptom.

Adynxx's lead compound, AYX1, is an investigational drug designed to reduce acute post-surgical pain and prevent the transition to persistent or chronic pain with a single administration at the time of surgery. 

Funded by Domain Associates, Adynxx has successfully completed a Phase 1 clinical study of AYX1 and completed enrollment in a Phase 2 study of AYX1 in Q3 2013.  Additional compounds targeting a range of intractable neuropathic and inflammatory pain syndromes are in the pre-clinical discovery stage.

Media Contact:

David Schull or Ian Stone
Russo Partners
(858) 717-2310
(619) 308-6541
david.schull@russopartnersllc.com
ian.stone@russopartnersllc.com


'/>"/>
SOURCE Adynxx
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Adynxx Enrolls First Patient in Phase 2 Proof-of-Concept Study for AYX1, Lead Compound for the Prevention of Post-Surgical Pain
2. Lead Therapeutic Candidate for Treatment of Pain from Adynxx, AYX1, Well-Tolerated in Phase 1 Clinical Study
3. Adynxx Completes Enrollment in Phase 1 Clinical Study of Lead Therapeutic for Treatment of Pain, AYX1
4. Otonomy Completes $45.9 Million Series C Equity Financing
5. BioReliance Opens New U.S. Clearance Services Laboratories; Completes Global Facility Upgrade Plan
6. SERVE-HF; the Worlds Largest Study of Sleep-Disordered Breathing in Heart Failure Completes Recruitment
7. OPKO Completes Acquisition Of PROLOR Biotech
8. Sleep Nation, Inc. Completes 43 Acquisitions
9. Arena Pharmaceuticals Completes Phase 1b Clinical Trial Evaluating APD811 for Pulmonary Arterial Hypertension
10. InspireMD Completes First Phase of Manufacturing Upgrade and Partners with HealthLink for Global Logistics and Distribution Services
11. Immune Pharmaceuticals Completes Merger with EpiCept Corporation
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... -- Research and Markets has announced ... Applications, Technologies, Forecasts" report to their offering. ... Smart Skin, Structural Health Monitoring, Composite Smart Structures, ... involves electronic and/or electrical components and circuits that ... such as vehicle bodies or conformally placed upon ...
(Date:6/24/2016)... Research and Markets has announced the ... Tests" report to their offering. ... The World Market for Companion Diagnostics covers the ... analysis in the report includes the following: ... Kits) by Region (N. America, EU, ROW), 2015-2020 , ...
(Date:6/24/2016)... Tenn. , June 24, 2016  Arkis ... providing less invasive and more durable cerebrospinal fluid ... in funding.  The Series-A funding is led by ... Lighthouse Fund, and other private investors.  Arkis, new ... neurosurgical instrumentation and the market release of its ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs surgery ... of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. , ... for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey ...
(Date:6/25/2016)... ... June 25, 2016 , ... Dr. Calvin ... injury. Recently, he has implemented orthobiologic procedures as a method for treating his ... of the first doctors to perform the treatment. Orthobiologics are substances that orthopaedic ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... 2016 , ... Comfort Keepers® of San Diego, CA is excited to announce ... program to drive cancer patients to and from their cancer treatments. Comfort Keepers ... of life and ongoing independence. Getting to and from medical treatments is one ...
Breaking Medicine News(10 mins):