(Nasdaq: NGSX), a biopharmaceutical company focused on developing novel
pain management therapies, announced that the Marketing Authorization
Application (MAA) submitted by NeurogesX for NGX-4010, the Company's lead
product candidate for peripheral neuropathic pain, has been accepted for
review by the European Medicines Agency (EMEA).
NGX-4010 is a dermal patch that has been studied successfully in three
Phase 3 clinical trials in patients suffering from peripheral neuropathic
pain conditions. Two Phase 3 clinical trials for the treatment of pain
associated with postherpetic neuralgia (PHN) and one for the treatment of
pain associated with painful HIV distal sensory polyneuropathy (HIV DSP)
demonstrated that a single 30 or 60 minute treatment with NGX 4010 applied
directly to the site of pain may provide pain relief for up to 12 weeks.
Completion of the acceptance period (or validation) signifies that the
EMEA will now begin review of NeurogesX' MAA. The review process is being
coordinated by the EMEA under the centralized procedure, which, if
resulting in approval, provides one marketing authorization for all
European Union (EU) Member States, as well as Iceland, Liechtenstein and
Norway.
Dr. Jeffrey Tobias, Chief Medical Officer, commented, "We believe that
the data included in our MAA filing, which includes data from more than
1,400 patients studied in our clinical trials, demonstrates the benefit of
NGX-4010 in treating patients suffering from peripheral neuropathic pain."
Anthony DiTonno, Chief Executive Officer, said, "Validation of our MAA
signifies a critical step in our worldwide NGX-4010 development strategy
and we look forward to productive interactions with the EMEA in order to
potentially gain marketing approval for this novel therapy. We also remain
focused on securing a partnering relationship in Europe prior to market
approval and are currently in active discussions with potential partners
for the commercialization of NGX-4010 in Europe. In addition to our
European filing, we anticipate filing a new drug application or (NDA) for
marketing approval in the United States in 2008."
NeurogesX recently announced that its second Phase 3 trial of NGX-4010
in postherpetic neuralgia (PHN) met its primary and all of its secondary
endpoints. In addition to the Company's PHN studies, NeurogesX has also
conducted a successful Phase 3 clinical trial of NGX-4010 in painful
HIV-DSP. As recently announced, the Company's second, ongoing confirmatory
Phase 3 trial for this indication has reached full enrollment and top-line
results are expected near the end of the first quarter of 2008. NGX-4010
has been granted orphan status and has received fast track designation from
the U.S. Food and Drug Administration (FDA) for HIV-DSP.
About NGX-4010
NGX-4010 is a non-narcotic, locally-acting analgesic formulated in a
dermal patch containing capsaicin, a highly selective TRPV1 agonist.
Capsaicin is released from the patch and absorbed into the skin without
significant absorption into the bloodstream. Accordingly, users of NGX-4010
may be able to avoid the systemic side effects of anti-convulsants,
anti-depressants and opioids, including sedation and the potential for
abuse and addiction associated with some of these drugs. NGX-4010 is
administered in a physician's office in a non-invasive process. In three
Phase 3 clinical trials, NGX-4010 has been shown to reduce peripheral
neuropathic pain for up to 12 weeks.
About PHN and HIV-DSP
PHN is a painful condition affecting sensory nerve fibers. It is a
complication of shingles, a second outbreak of the varicella-zoster virus,
which initially causes chickenpox. Following an initial infection, some of
the virus can remain dormant in nerve cells. Years later, age, illness,
stress, medications or other factors that are not well understood can lead
to reactivation of the virus. The rash and blisters associated with
shingles usually heal within six weeks, but some people continue to
experience pain for years thereafter. This pain is known as postherpetic
neuralgia. PHN may occur in almost any area, but is especially common on
the torso.
HIV-DSP is caused primarily by three factors: direct activation of
cells known as sensory neurons by the HIV virus, the immune system's fight
against the infection, and the drugs administered to treat HIV. Painful
HIV-DSP is characterized by significant pain in the feet and hands.
About NeurogesX, Inc.
NeurogesX (Nasdaq: NGSX) is a biopharmaceutical company focused on
developing novel pain management therapies. Its initial focus is on chronic
peripheral neuropathic pain, including PHN, painful HIV-DSP and painful
diabetic neuropathy (PDN). NeurogesX's late stage product portfolio is led
by product candidate NGX-4010, a dermal patch designed to manage pain
associated with peripheral neuropathic pain conditions, that the Company
believes offers significant advantages over other pain therapies. Three
Phase 3 clinical trials with NGX-4010 have been completed and have met
their primary endpoints, two in PHN and one in HIV-DSP.
Safe Harbor Statement
This 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 contained in the
Act for forward- looking statements. Examples of such statements include,
but are not limited to, statements regarding NGX-4010 clinical trials,
including the timing of completion of such trials; filings for regulatory
approval in the United States and the timing of such filings as well as the
scope of the indications that the Company is seeking approval for with
respect to its filing with the EMEA; the potential markets for NGX-4010;
the potential efficacy and benefits of NGX-4010; and NeurogesX' plans to
enter into commercial partnerships. 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,
subsequent analysis of data from NeurogesX' C117 trial may cause the
results to be viewed less favorably as compared to NeurogesX' initial
analysis of such trial's results; past results of clinical trials may not
be indicative of future clinical trials results; NGX-4010 may have
unexpected adverse side effects or inadequate therapeutic efficacy;
positive results in clinical trials may not be sufficient to obtain FDA or
European regulatory approval; physician or patient reluctance to use
NGX-4010, if approved, or the inability of physicians to obtain sufficient
reimbursement for such procedures; potential alternative therapies and
changing standards of care; maintaining adequate patent or trade secret
protection without violating the intellectual property rights of others;
NeurogesX' ability to obtain additional financing; NeurogesX' ability to
obtain and maintain future commercial partnerships; and other difficulties
or delays in clinical development, obtaining regulatory approval, market
acceptance and commercialization of NGX-4010. 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.
neurogesx
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