Ketamine is a drug that has been used for over 35 years in human anesthesia and veterinary medicine. More recently, ketamine has been shown in several randomized, placebo-controlled trials to produce rapid antidepressant effects in patients with treatment-resistant depression (TRD). Ketamine has also been shown to rapidly reduce suicidal thinking. However, significant challenges exist for ketamine’s routine use for treating TRD. The fact that ketamine is not FDA approved for depression will limit dissemination and will not encourage standardization of best practices for mode of administration, dosing and frequency. In addition, ketamine can cause dissociative side effects, has a relatively short duration of action and is primarily administered by invasive intravenous infusion.
With regard to moderate-to-severe pain, ketamine’s mechanism of action is well understood and its off-label use as a potent analgesic has been well documented. As a matter of fact, the U.S. military has been successfully using ketamine for the past several years for acute pain management and it has quickly become a preferred agent in battlefield pain management. Ketamine has been shown to have a wide margin of safety, positively impact the respiratory system and has less potential for addiction than opioids. But, as with TRD, several of the same challenges exist for ketamine’s broader adoption for treating moderate-to-severe pain.
About Amorsa’s Technology
Building on ketamine’s proven success as a rapid-acting antidepressant and potent analgesic, Amorsa is developing novel non-invasive therapeutic agents based on proprietary analogs of ketamine. Compared to ketamine, Amorsa’s product candidates are designed to possess a more favorable safety profile, extend the duration of action and enable oral dosing while maintaining ketamine’s therapeutic benefits.