Navigation Links
Arcion Therapeutics Receives FDA Fast Track Designation for ARC-4558 for the Treatment of Pain Associated with Painful Diabetic Neuropathy
Date:9/14/2010

BALTIMORE, Sept. 14 /PRNewswire/ -- Arcion Therapeutics, a venture backed clinical stage biotechnology company developing topical therapies for chronic pain, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ARC-4558 for the treatment of pain associated with Painful Diabetic Neuropathy (PDN). ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride for topical administration. Arcion recently announced positive top-line results from a Phase 2b double-blind, randomized, placebo-controlled clinical trial of ARC-4558 in adult patients with PDN. The Company also recently held an End of Phase 2 meeting with the FDA and the ARC-4558 program is now poised to enter Phase 3 studies.

The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs typically qualify for priority review, thereby expediting the FDA review process.

"This Fast Track designation is an important recognition by the FDA of the potential for ARC-4558 to address the unmet need for better agents to control the pain involved in PDN, a serious condition," said James Campbell, M.D., Chief Executive Officer of Arcion. "Having the Fast Track designation will be of great value to Arcion as we work with the FDA to come to an agreement on the final Phase 3 program, as well as open the way to a potential priority review."  

About ARC-4558

ARC-4558 is a 0.1% gel formulation of clonidine hydrochloride (HCL) for topical administration to the painful area in order to manage the neuropathic pain associated with painful diabetic neuropathy (PDN).  Topical clonidine, through its agonist effects on alpha2 (a2)-adrenergic receptors, is believed to reduce pain in PDN via local actions on the nociceptors that innervate the affected skin. Based on the results of clinical trials to-date, Arcion believes that ARC-4558 has a level of efficacy comparable to systemic therapies in the target population, but with substantially fewer side effects. The 0.1% gel formulation avoids the treatment area limitations and undesirable aesthetic and skin reaction issues associated with analgesic patches. Furthermore, the ARC-4558 gel has been shown to provide analgesia without numbing or anesthetizing the skin.

About Painful Diabetic Neuropathy (PDN)

Neuropathy is a common complication of diabetes mellitus. According to 2008 estimates by the Centers for Disease Control and Prevention, nearly 18 million people in the United States are diagnosed with diabetes. Given a conservative estimate that 15% of people with diabetes have painful neuropathies, approximately 2.7 million Americans experience PDN. Patients with PDN often experience debilitating pain symptoms that affect day-to-day functioning and quality of life.  How diabetes causes a length-dependent neuropathy is unknown.  Arcion believes the PDN market is highly under-served by existing products and that there is a strong scientific rationale for developing a topical treatment for PDN that delivers analgesia in a way that avoids systemic side effects.

About Arcion

Arcion Therapeutics applies breakthroughs in neuroscience to advance the treatment of chronic pain. The company focuses on innovative topical treatments to provide pain relief with convenient application and reduced systemic side effects. Arcion's product pipeline comprises multiple candidates to treat neuropathic pain.  www.arciontherapeutics.com


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

Related medicine technology :

1. Arcion Therapeutics Topical Gel Candidate, ARC-4558, Demonstrates Significant Pain Reduction in Phase 2b Trial for Painful Diabetic Neuropathy (PDN)
2. Anesiva Announces Merger With Arcion Therapeutics Will Not be Completed
3. Arcion Therapeutics Topical Pain Candidate, ARC-4558, Significantly Reduces Pain Caused by Diabetic Neuropathy
4. Orexigen® Therapeutics to Speak at Rodman & Renshaw Annual Global Investment Conference
5. Halozyme Therapeutics Announces Public Offering of Common Stock
6. Silence Therapeutics Issued New Patents Covering siRNA Sequences for RNA Interference Therapeutics
7. Precision Therapeutics, Inc. Named to Pittsburgh Business Times 2010 Top 100
8. Orexigen® Therapeutics and Takeda Enter Into Partnership to Commercialize Contrave® in North America
9. Reportlinker Adds Urological Disorders Therapeutics to 2016 - Increasing Awareness and Aging Population will Drive the Benign Prostatic Hyperplasia and Urinary Incontinence Markets
10. Orexigen(R) Therapeutics Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)
11. Echo Therapeutics Announces Successful Completion of Clinical Trial for Prelude™ SkinPrep System and 4% Lidocaine Cream
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/22/2017)... 22, 2017 Research and Markets has ... Market (Thermometers - Digital, Infrared, Mercury; Trend Indicator):Analysis By Region, By ... ... is forecasted to grow at a CAGR of 5.33% during 2016-2021 ... of infectious diseases along with surging demand of digital thermometer. Apart ...
(Date:2/22/2017)... Oncternal Therapeutics, Inc., a clinical-stage biotechnology ... common malignancies, today announced the closing of an ... to use the proceeds to further clinical development ... preclinical development of a new ROR1-targeted antibody-drug conjugate ... anti-ROR1 monoclonal antibody being developed to treat patients ...
(Date:2/22/2017)... , Feb. 22, 2017 Kineta, ... development of novel immune modulating therapies, today announced ... a9a10 nicotinic acetylcholine receptor (nAChR), demonstrates robust chronic ... pain models. The study also establishes the a9a10 ... treatment of chronic pain. The findings were reported ...
Breaking Medicine Technology:
(Date:2/22/2017)... CA (PRWEB) , ... February 22, 2017 , ... ... American adults with chronic conditions reported skipping doses or not filling a prescription ... uninsured or under-insured, rates of cost-related problems getting medications were 30-60%*. ...
(Date:2/22/2017)... PA (PRWEB) , ... February 22, 2017 , ... Sideline ... where the company met national TV host Tom Seay and his production crew. ... a favorite among equestrians around the world. Saddle Sidekicks will be featured on ...
(Date:2/22/2017)... ... February 22, 2017 , ... The first-ever National Heart ... advocates, and individuals join together to increase recognition about the risks of heart ... , “Today we mark a nationwide movement to raise awareness about a disease ...
(Date:2/22/2017)... MADISON HEIGHTS, MICHIGAN (PRWEB) , ... February 22, ... ... news and analysis of issues related to spine practices, is featuring Michigan neurosurgeon ... Jagannathan is known as one of a small number of neurosurgeons in Michigan ...
(Date:2/22/2017)... ... 22, 2017 , ... Michael J. Hennessy Associates, Inc. (MJH ... technology professionals and other key stakeholders with an array of valuable resources, Healthcare ... 1, announced Michael J. Hennessy, Jr., president of MJH Associates. , In ...
Breaking Medicine News(10 mins):