SeValent™ can rejuvenate value therapies by allowing subcutaneous delivery of compounds that are currently limited to IV administration.
Expand the potential small molecule therapies by attuning dosage & PK control with a patient friendly delivery, leading to procedural cost savings.
Licensing partners and their therapies will benefit from:
Extend patent-life or achieve formulation-like NCE
Lowering procedural burdens
Precise response across patients and across treatments
Control the “in and out”
Lowered metabolite exposure and response variability
Improve Cmax and Tmax
Achieve steady state or as needed delivery
Built in regulatory advantage
Critical need for more and better PTSD treatment options PTSD costs society billions in health care & lost productivity
Address a long felt need for a treatment & ROA designed for the psychiatrist’s office Develop an indication that expands beyond TRD, which is becoming crowded with empathogens & 5HT2A agonists
1 Coherent Market Research
DMT is the prototypical psychedelic but:
DMT shows strong potential in mental health if you can control entry, altitude and exit of the experience. Bexson's Sub-Q DMT + pump can manage this gracefully.
1 Coherent Market Research
IV-only infusion treatments are very expensive.4 Requires in-clinic IV administration or very expensive at home services.
Moving from IV to SubQ wearable delivery will improve patient safety & convenience. Large cost savings by removing clinic and daily IV services. 505b2 regulatory pathway
4 JAMA Network Open. 2022
5 Research and Markets (Dec 2021)
SeValent™ fixes numerous problems: “Empowering Delivery in Mental Health”
Decriminalization efforts have obscured awareness of the need for diversion control for scheduled drugs for FDA approval.
Bexson’s wearable system is specifically designed with layered protections against drug diversion and tampering.
Psychiatrists do not offer IV service. IV drug delivery is expensive, medicalized & uncomfortable.
Drug delivery by a wearable, pre-programmed device reduces cost and is much more patient friendly. Matches the cultural and practical realities of the target specialty - PSYCHIATRY.
Oral dosing sends medicine through the GI tract, which is laden with 5HT2A receptors, causing nausea, vomiting and malaise with psychedelics.
SubQ administration skips the GI tract to substantially reduce side effects, and improve psychic aspects of the treatment.
Oral dosing sends drug by the liver creating large variations in blood level and response. Correct therapeutic effect should not be so hard to achieve.
SubQ delivery avoids the GI tract and early drug metabolism, instead going through SubQ tissue into the bloodstream.
Waiting for onset and multiple hour timeframes with oral dosing is not a viable model in many cases
Bexson’s Subcutaneous formulations & wearable device offer full control of ONSET, ALTITUDE & LANDING of a treatment. Wearable subQ infusion can be thought of as a pocket IV.
Bexson's formulation technology for small molecules provides patent renewal/reinvigoration.
This applies to Sub-Q, IM, IV and Intranasal preparations.
SeValent™ Formulation IP also covers known molecules, as well as not yet created NCEs and Prodrugs.
This also includes lyophilized formulations reconstituted on-site for delivery (e.g.- antibiotics, anti-viral, anti-fungal).
A modular platform with strong IP protection: USPTO allowance covering the application of SeValent™ to any molecule that has an ionizable nitrogen. Applicable to any molecule regardless of therapeutic area, including NCEs not yet invented.
A dynamic programmable drug delivery platform that can be repurposed for various drugs.