|Product / Indication||Phase One||Phase Two||Phase Three||Registration||Market|
AmiKet™Neuropathic (PHN, CPN, DPN)
Relief of pain associated with neuralgia due to diabetes (DPN), chemotherapy (CPN) or shingles in adults (PHN)
15 million patients
4% amitriptyline and 2% ketamine cream
Dosage and Administration
4 mL topical cream twice daily
Mild sensitivity at application site
Over 1,300 patients treated in seven clinical trials
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.
Stage of Development
We believe AmiKet™ is ready to enter Phase III testing. EpiCept intends to partner AmiKet™ prior to the commencement of the Phase III program in order to share the costs and development risk, and ultimately to have that partner market the product globally upon approval. Partner discussions are continuing.