For that reason You'll find the original findings from 2009/10 reproduced below (see link below article). If we're once again denied a treatment that is clearly suitable for HIV patients with neuropathy, we may be justified in feeling aggrieved! Draw your own conclusions.
* Useful comment from Anonymous received May 28th (see below article)
FDA grants Fast Track designation to EpiCept's AmiKet
Published on April 10, 2012
EpiCept Corporation (Nasdaq OMX Stockholm Exchange and OTCQX: EPCT) announced today that AmiKet™ (amitriptyline 4%, ketamine 2% cream) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA). AmiKet™ is the Company's late-stage product for the treatment of neuropathic pain associated with chemotherapy-induced peripheral neuropathy (CIPN) in patients previously treated with taxane-based chemotherapy.
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs. According to the FDA, products with a Fast Track designation oftentimes receive priority review, which may reduce the standard review time by half. The Fast Track designation also allows for more frequent interactions with the FDA during the drug development process.
"We believe the FDA Fast Track designation is confirmation of the pressing need for therapies to treat neuropathic pain associated with CIPN," said Jack Talley, President and Chief Executive Officer of EpiCept. "We expect the receipt of this designation will prove to be highly valuable in our current partnering efforts for AmiKet™."
EpiCept previously announced the engagement of SunTrust Robinson Humphrey to assist in exploring strategic alternatives to maximize the commercial opportunity of AmiKet™. The engagement will focus on the identification and implementation of a strategy to optimize AmiKet's value for the Company's stockholders.
http://www.news-medical.net/news/20120410/FDA-grants-Fast-Track-designation-to-EpiCepts-AmiKet.aspx
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AmiKet™
Indication
Relief of pain associated with neuralgia due to diabetes (DPN), chemotherapy
(CPN) or shingles in adults (PHN)
A four-week, Phase IIb 200-patient trial in diabetic peripheral neuropathy (DPN) has been performed (Neuracept) in this type of neuropathic pain, the results of which were reported in February 2008. The Neuracept trial was a double blind, placebo-controlled study of AmiKet™ in 215 DPN patients who completed the trial. The data demonstrated that the primary endpoint, the difference in changes in pain intensity between AmiKet™ and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715). Key secondary endpoints measured in the trial indicate that 60% of patients in the AmiKet™ treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the AmiKet™ treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078). All pain scores measured trended in favor of the AmiKet™ treated patients over the placebo group, indicative of an analgesic effect. The preliminary data derived from the trial support the continued study of AmiKet™ in a late-stage pivotal clinical trial.
In January 2009, the results of a four-week, Phase IIb, 360- patient trial in post-herpetic neuralgia (PHN) were reported. The trial compared the efficacy and safety of AmiKet™ against both gabapentin and placebo. The data demonstrated that AmiKet™ achieved statistically significant superior efficacy compared with placebo (p=0.024). An additional primary endpoint, to demonstrate that AmiKet™ was not inferior to gabapentin in reducing pain, was also met. A key secondary endpoint measured in the trial from a responder analysis indicated that 63% of patients in the AmiKet™ treatment arm achieved a reduction in pain scores of at least 30%, significantly higher than that of patients in the placebo arm (p=0.033). Data results further indicate that AmiKet™ achieved a superior safety profile when compared with gabapentin, especially with regard to dizziness and somnolence, as evaluated by the reporting of adverse events.
http://ceplenecom.siteprotect.net/epicept/product-and-pipeline?product=epicept
Target Population
15 million patientsDescription
4% amitriptyline and 2% ketamine creamDosage and Administration
4 mL topical cream twice dailyAdverse Reactions
Mild sensitivity at application siteExperience
Over 1,300 patients treated in seven clinical trialsDescription
AmiKet™ is a prescription topical analgesic cream designed to provide effective, long-term relief from the pain of peripheral neuropathies. Peripheral neuropathies are medical conditions caused by damage to the nerves in the peripheral nervous system. The peripheral nervous system includes nerves that run from the brain and spinal cord to the rest of the body. It is estimated that these conditions affect more than 15 million people in the U.S. These conditions are caused from injured peripheral nerves, following herpes zoster, or shingles, diabetes, chemotherapy, HIV and other diseases. Peripheral neuropathies can also be caused by trauma or may result from surgical procedures. AmiKet™ cream is a patented formulation containing two FDA-approved drugs, amitriptyline (a widely-used antidepressant) and ketamine (an NMDA antagonist that is used as an anesthetic).A four-week, Phase IIb 200-patient trial in diabetic peripheral neuropathy (DPN) has been performed (Neuracept) in this type of neuropathic pain, the results of which were reported in February 2008. The Neuracept trial was a double blind, placebo-controlled study of AmiKet™ in 215 DPN patients who completed the trial. The data demonstrated that the primary endpoint, the difference in changes in pain intensity between AmiKet™ and placebo over the four week duration of the trial, nearly reached statistical significance (p=0.0715). Key secondary endpoints measured in the trial indicate that 60% of patients in the AmiKet™ treatment arm achieved a reduction of pain scores of at least 30% compared with 48% of patients in the placebo arm (p=0.076). In addition, 33% of patients in the AmiKet™ treatment arm achieved a reduction in pain scores of at least 50% compared with 21% of patients in the placebo arm (p=0.078). All pain scores measured trended in favor of the AmiKet™ treated patients over the placebo group, indicative of an analgesic effect. The preliminary data derived from the trial support the continued study of AmiKet™ in a late-stage pivotal clinical trial.
In January 2009, the results of a four-week, Phase IIb, 360- patient trial in post-herpetic neuralgia (PHN) were reported. The trial compared the efficacy and safety of AmiKet™ against both gabapentin and placebo. The data demonstrated that AmiKet™ achieved statistically significant superior efficacy compared with placebo (p=0.024). An additional primary endpoint, to demonstrate that AmiKet™ was not inferior to gabapentin in reducing pain, was also met. A key secondary endpoint measured in the trial from a responder analysis indicated that 63% of patients in the AmiKet™ treatment arm achieved a reduction in pain scores of at least 30%, significantly higher than that of patients in the placebo arm (p=0.033). Data results further indicate that AmiKet™ achieved a superior safety profile when compared with gabapentin, especially with regard to dizziness and somnolence, as evaluated by the reporting of adverse events.
http://ceplenecom.siteprotect.net/epicept/product-and-pipeline?product=epicept
If you study the FAS III proposal FDA has recommended a FAS IV follow up study in an other neuropathic pain to give AmiKet the possibility to be accepted for the broader acceptance of pain.
ReplyDeleteThanks, that's very useful information.
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