Navigation Links
NeurogesX Doses First Patient in Phase 2 Clinical Study of NGX-1998 Liquid Capsaicin Formulation
Date:11/2/2010

SAN MATEO, Calif., Nov. 2, 2010 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today announced dosing of the first patient in its Phase 2 clinical study of NGX-1998, a liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN).

The target profile for NGX-1998 is to provide safety, efficacy and tolerability that is at least comparable to Qutenza® (capsaicin) 8% patch with a significantly shorter application time.

The Phase 2, adaptive-design, clinical study will be conducted in two stages. The first stage is designed to determine the shortest tolerable anesthetic pretreatment regimen. The second stage will evaluate two NGX-1998 dose concentrations using the pretreatment regimens determined during stage 1. The objective is to select the appropriate concentration of NGX-1998 and pretreatment period for further evaluation in a Phase 3 clinical program. Up to 200 PHN patients are targeted for enrollment.

Jeffrey Tobias, MD Executive Vice President for Research and Development and Chief Medical Officer commented, "We are very pleased to have initiated our Phase 2 study of NGX-1998. Previous Phase 1 studies have suggested that NGX-1998 may deliver an effective dose of capsaicin in as little as five minutes. This study will now explore the shortest tolerable pretreatment regimen as well as provide preliminary efficacy and safety data of two concentrations of NGX-1998 in patients with PHN. These data will help us select the optimal dose of NGX-1998 and shortest overall treatment regimen. NGX-1998 is an important product candidate for the long-term growth of our neuropathic pain franchise and we are happy to have this clinical trial underway."

About NeurogesX, Inc.NeurogesX, Inc. (Nasdaq: NGSX) is a San Francisco Bay Area-based biopharmaceutical company focused on developing and commercializing novel pain management therapies. NeurogesX was founded on the concept that use of prescription-strength capsaicin could help manage the pain associated with neuropathic pain conditions. Since its inception, NeurogesX has leveraged its passion to help people with pain to efficiently develop this concept, resulting in the commercial launch of Qutenza® (capsaicin) 8% patch in 2010. The Company continues to apply its knowledge and expertise in the development of other novel treatments for pain.

The Company's lead product, Qutenza, is a localized dermal delivery system containing prescription strength capsaicin that is currently approved in the United States and the European Union. Qutenza is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European subsidiary of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The Company is currently preparing to submit a supplemental new drug application for Qutenza for the management of pain due to  HIV-distal sensory neuropathy, or HIV-DSP, also known as HIV-associated neuropathy, or HIV-AN. The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 is currently enrolling PHN patients in a Phase 2 clinical study.

The Company's early-stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. The Company has evaluated these compounds in vitro and in vivo.

Safe Harbor StatementThis press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to: statements regarding to the Phase 2 clinical trial of NGX-1998, including with respect to trial design and planned enrollment; the potential benefits of NGX-1998, including with respect to efficacy and tolerability; and NeurogesX' proposed supplemental new drug application for Qutenza label expansion.  Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: difficulties or delays in the conduct of the clinical trial for NGX-1998; past clinical trial and other data associated with NGX-1998 may not be indicative of such product candidate's performance in current or future clinical trials; difficulties or delays in the submission of the supplemental new drug application for Qutenza; market acceptance of Qutenza in already approved indications may not be sufficient to support further pursuit of an expanded label for Qutenza, including as a result of physician or patient reluctance to use Qutenza; Qutenza and NeurogesX' other product candidates may have unexpected adverse side effects; and potential alternative therapies. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.NeurogesX, Inc.The Ruth GroupStephen Ghiglieri

Sara Pellegrino (investors)Executive Vice President, COO

(646) 536-7002and CFO

spellegrino@theruthgroup.com(650) 358-3310Jason Rando (media)(646) 536-7025jrando@theruthgroup.com
'/>"/>

SOURCE NeurogesX
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. NeurogesX to Hold Conference Call to Discuss Third Quarter 2010 Results
2. NeurogesX to Present at Oppenheimer & Co Healthcare Conference
3. Although NeurogesX/Astellass Qutenza is Only Approved for Postherpetic Neuralgia, Surveyed U.S. Physicians are Likely to Prescribe It for All Neuropathic Pain Types
4. NeurogesX Appoints Seasoned Sales and Marketing Executive as New Board Director
5. NeurogesX Receives FDA Approval of Qutenza(TM) (capsaicin) 8% Patch for Treatment of Postherpetic Neuralgia (PHN)
6. NeurogesX Expands Commercial Operations Leadership Team
7. NeurogesX to Hold Conference Call to Discuss Third Quarter 2009 Financial Results
8. NeurogesX to Present at JMP Securities Healthcare Focus Conference
9. NeurogesX Announces Preliminary Results of FDA-Requested Qutenza(TM) Study
10. NeurogesX Receives FDA Orphan Drug Designation for Qutenza(TM) for Treatment of Postherpetic Neuralgia
11. NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in Postherpetic Neuralgia (PHN) by The Lancet Neurology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016 Bracket , a leading clinical trial ... clinical outcomes platform, Bracket eCOA (SM) 6.0, at the ... – 30, 2016 in Philadelphia , Pennsylvania.  ... Assessment product of its kind to fully integrate with RTSM, ... eCOA 6.0 is a flexible platform for electronic clinical outcomes ...
(Date:6/23/2016)... , June 23, 2016 Revolutionary ... Oticon , industry leaders in advanced audiology ... of Oticon Opn ™, the world,s first internet ... possibilities for IoT devices.      (Photo: ... introduces a number of ,world firsts,: , ...
(Date:6/23/2016)... Tenn. , June 23, 2016 /PRNewswire/ ... automating, integrating and transforming the patient payment ... of several innovative new products and services ... of its revenue cycle offerings. These award-winning ... more efficient workflows, remain compliant in an ...
Breaking Medicine Technology:
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
(Date:6/24/2016)... ... ... makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for a Fair Minimum ... by 2020 and then adjusting it yearly to increase at the same rate as the ... wage floor does not erode again, and make future increases more predictable. , The company ...
(Date:6/24/2016)... ... June 24, 2016 , ... Strategic Capital Partners, LLC ... by obtaining investment capital for emerging technology companies. SCP has delivered investment ... resulted in more than a million dollars of capital investment for five companies. ...
(Date:6/24/2016)... ... ... Finally, a bruise cream that really works. Originally designed to reduce ... post-surgical treatment plans of a variety of other procedures including, but not limited to, ... bruising and causes a rapid resolution of bruising and inflammatory changes compared to no ...
(Date:6/24/2016)... ... 2016 , ... Dr. Seema Daulat, a native Texan and University of Texas ... as of July 13, 2016. , Dr. Daulat earned her Doctorate of Medicine (MD) ... volunteered at the Agape Clinic serving Dallas’ underprivileged community. , Following medical school, Dr. ...
Breaking Medicine News(10 mins):