Ketamine, used legally in anesthesia and illegally as a street drug, has ginned up considerable interest as a painkiller and as a treatment for mental disorders like depression. Now, two drugmakers are joining forces to create a ketamine delivery device that could manage patients' pain at home.
Santa Barbara, California-based Bexson Biomedical has teamed up with Italy’s Stevanato Group to develop a wearable ketamine pump using Bexson's subcuteanous drug formulation and Stevanato's delivery platform, the SG EZ-be Pod.
Stevanato's matchbox-sized device, designed as an alternative to pen injectors, sticks to the body and can be worn for up to 72 hours.
If the work pans out, Stevanato and Bexson think their pump could offer patients not only a convenient alternative to IV infusions, but a nonaddictive alternative to opioids for pain treatment at home—where dependence and abuse often arise—Bexson’s co-founder and CEO Gregg Peterson said in a release.
Given the need to control ketamine dosing and monitor patients after treatment, healthcare providers have limited ability to send patients home with a prescription. Bexson aims to change that with its novel formulation, deliverable through the skin and effective at doses "substantially lower" than those used to treat depression, the company said.
Bexson in 2019 won FDA orphan status for its ketamine formulation in complex regional pain syndrome. The drugmaker is also targeting post-surgical pain management and exploring the drug’s potential to provide relief from other conditions like migraine, neck trauma, nerve injury and more.
While Bexson hopes to be on the forefront of simpler ketamine therapies for chronic and acute pain, it’s not the first drugmaker to reformulate the popular anesthetic.
Johnson & Johnson in 2019 scored its first approval for its nasal spray version of ketamine, esketamine, to treat depression patients who had tried at least two other antidepressants. Now marketed as Spravato, the drug recently won a new FDA green light to treat depressive symptoms in adults with major depressive disorder with acute suicidal thinking or behavior.
J&J launched the drug under an FDA-mandated “controlled distribution model”: Patients can’t take the medication at home and must remain under doctor supervision for at least two hours following treatment.
Editor's note: This article has been edited to reflect that Spravato is approved to treat depressive symptoms in adults with MDD with acute suicidal ideation or behavior.