NAPLES, Fla.—Synergistic Therapeutics LLC recently announced issuance of a U.S. Patent for a sublingual antidepressant lozenge with ketamine, which is used to treat anxiety, depression, major depressive disorder (MDD) and treatment-resistant depression (TRD). The Florida-based company, formed in 2015, specializes in manufacturing and formulating topical and sublingual pharmaceutical solutions.
Current routes of administration for ketamine-based compounds present major obstacles to clinical applicability, especially in community settings. Intravenously administered ketamine requires observation, and patients typically require multiple infusions each week, which can be inconvenient for many. In March 2019, the FDA approved an intranasal spray medication for treatment-resistant depression (TRD). But intranasal delivery may be inconsistent, as patients may receive a wide variance of absorption, depending on the individual. This method also requires administration in a controlled environment, making it difficult for community settings.
Synergistic Therapeutics’ sublingual ketamine lozenges can easily be taken once per day or once every other day as any other ordinary medication, and may not require observation or administration in a controlled environment. Similar to an intravenous infusion, the sublingual method also provides a fast-acting approach for MDD and TRD, as well as for depressed people with suicidal ideation or behaviors.
Ketamine was originally developed and was approved in 1970, initially utilized as an anesthetic. Numerous controlled clinical trials and studies have shown the safety and efficacy of ketamine in the treatment of MDD and TRD.
Major depressive disorder and treatment-resistant depression affect approximately 16 million people in the U.S. and 121 million people worldwide, and are some of the most common mental disorders in the United States. It’s estimated that nearly 7 percent of Americans over age 18 have experienced an episode of MDD or TRD. Individuals with depression experience continuous suffering from a serious, biologically-based disease which can prevent them from enjoying life and functioning normally.
Depression is also the psychiatric disorder most commonly associated with suicide. In the U.S. alone, there are more than 41,000 suicides each year, many of which result from untreated or poorly treated depression. Only 25 percent of patients on currently available antidepressants achieve remission. While conventional antidepressants can be effective, their delayed onset of effect, which may take three to six weeks, limits their value in treating acutely suicidal patients.
Studies have found positive results via sublingual ketamine with patients suffering from addiction, Alzheimer’s, bipolar disorder, dementia, postpartum depression, and post-traumatic stress disorder (PTSD). The company is also studying the effects of ketamine for other neurological and cognitive disorders.