AmiKet™ / AmiKet Nano
AmiKet is a phase 3-ready topical analgesic cream containing two FDA-approved drugs: amitriptyline, an antidepressant often used to treat chronic pain disorders; and ketamine, an N-methyl-D-aspartic acid ("NMDA") antagonist that is used as an intravenous anesthetic. AmiKet has completed phase 1 and 2 clinical trials involving 1,600 subjects for the treatment of neuropathic pain. In 2010, the FDA granted AmiKet Orphan Drug Designation for the treatment of PHN. A PHN phase 3 clinical trial has been designed based on prior clinical studies, including a phase 2 trial that showed non-inferior efficacy of AmiKet to oral gabapentin and statistically significantly better efficacy than placebo (clinicaltrials.gov, Identifier: NCT00475904). In addition to PHN, AmiKet may be developed for the treatment of diabetic neuropathy and chemotherapy-induced peripheral neuropathy. We have also developed a new formulation of AmiKet, AmiKet Nano, which utilizes the proprietary, patent-protected nano-encapsulation technology used for NanoCyclo. AmiKet Nano may offer similar efficacy or improved efficacy with lower doses of amitriptyline and ketamine, thus improving the therapeutic index of the combination. Immune is seeking a partner to further the development of this program.