22nd Annual Pain Medicine Meeting 2023

Clinically meaningful radicular leg pain management via SX600, a novel dexamethasone extended-release microsuspension SALIENT Phase 1/2 trial results

BACKGROUND:

•Management of lumbar radicular pain remains challenging

•ESIs commonly administered off-label

• Need for repeated injections is common

• Risk of serious neurologic events particularly with corticosteroid suspensions

•SX600 is a novel ER formulation of dexamethasone acetate incorporated into biodegradable PLGA microspheres

•Formulation provides 90 days of dexamethasone exposure

•Key SX600 microsphere design characteristics (small diameter [≤ 50% of RBCs], spherical, non-aggregating), take into consideration reports of serious neurologic sequelae with ESIs attributable to inadvertent intravascular administration

CONCLUSIONS:

•SX600 provided clinically meaningful, durable unilateral radicular leg pain reduction after a single TF-EI

•≥ 64% who received SX600 25 mg had ≥ 50% improvement of WDLP from day 30 – 180 visits

•Magnitude considered substantial and clinically relevant

•Accompanied by improvements in function, QOL, patient perceived improvement, less rescue medication

•Sustained 3-month DXM exposure with SX600 25 mg

•Overall safety profile favorable and comparable to placebo

22nd Annual Pain Medicine Meeting 2023

CLINICALLY MEANINGFUL RADICULAR LEG PAIN MANAGEMENT VIA NOVEL DEXAMETHASONE EXTENDED-RELEASE MICROSUSPENSION (SX600)–PH1/2 RESULTS

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