Bexson Biomedical recently signed a deal with the Stevanato Group to develop a subcutaneous delivery system of ketamine.
“SG EZ-be Pod,” a wearable device designed for administering subcutaneous drugs, would facilitate patient administration of medications outside of clinics and hospitals.
At the time deal was announced, Bexson stated that the goal of the novel system would be for pain management and that the company’s formulation technology could work with other molecules beyond ketamine.
Benzinga reached out to Jeff Becker, Bexson's chief science officer, for further information. He explained that the delivery of some psychedelics through this system could help tackle some of the limitations the substances face.
What would the device improve?
For example, he named DMT. To achieve certain desirable blood levels with DMT, monoamine oxidase inhibitors (MAOIs) are required. Without them, the gastrointestinal tract and liver break down the molecule, but for patients who take SSRIs such as Prozac, MAOIs are contraindicated since the mix can be lethal.
Furthermore, when infusion with Bexson and Stevanato’s new system stops, patients would return to normal consciousness in approximately 15 to 20 minutes, making DMT treatments more homogeneous and predictable. In comparison to oral psychedelics, which tend to be far more variable in their effects and duration, subcutaneous delivery would be more controllable by therapists.
“To be clear, what we are proposing is similar to what can be done with an IV formulation,” Becker added. “The problem with IV formulations is the notable expense and procedural burden it demands. There is also the issue of expertise required to deliver medications in this way. This is generally not a skill set held by psychiatrists, and this is why most IV ketamine clinics are run by anesthesia and ER doctors, rather than psychiatrists.”
In the clinic or at home?
When asked if the system is primarily designed to be used in a clinic or as a daily delivery device (as is the case with insulin), Becker told Benzinga that “the delivery profile for ketamine makes an enormous difference in achieving different treatment outcomes.”
On the one hand, the flagship project of Bexson Biomedical is targeted toward acute pain management. “The dosing range of ketamine that can be employed in acute pain management goes substantially lower than with depression and other mental health indications,” he explained. “We hope our pain management product line will enable patients to self-administer small sub-dissociative doses of ketamine safely for post-operative pain management over a number of days.” In this case, the administration profile of ketamine would be of low doses over a certain number of days, with certain similarities to the way analgesics are administered in a hospital setting.
On the other hand, the system could be used as a treatment for major depression, suicidality and treatment-resistant depression. This would mean a different delivery profile, with higher doses delivered over 30 to 60 minutes. “The delivery profile may in fact mimic IV ketamine delivery protocols, which have been highly validated,” Becker said. “All of our programs will go through standard FDA approval process that entails phase studies and IND application to the FDA.”
What indications could benefit from a subcutaneous drug delivery system with psychedelics?
Becker said different classic psychedelics can help with a variety of health issues. For instance, they could serve the same purpose as anti-inflammatory medication for moderate chronic pain, or for “requirement of cognitive function after traumatic brain injury.”
There is also evidence that psychedelics in low and mid dosing ranges could help manage cluster headaches.
Becker concluded by saying that “we are at the beginning of a long science journey determining how to apply these interesting treatments in bettering human health, but there is a lot more we need to know.”
