Expansion of Engineering and Testing for 'Locally Targeted Acoustic Neuropathy Medication Delivery System for Pain Relief without Large Systemic Doses and Side Effects'

This Phase I SBIR develops the Locally Targeted AcousticLTANeuropathy Medication Delivery System to effectively provide localized analgesia via direct transdermal delivery of medications to target nervesimproving efficacy and eliminating both wasted discarded drug and the negative side effects associated with oral systemic deliveryPublic Health ProblemPeripheral NeuropathyPNis a series of disorders resulting from damage to the peripheral somatosensory nervous system resulting from lesioninjuryor diseaseDebilitating symptoms of PN include numbnesstinglingand or pain sensations such as allodyniaa normally non painful stimulus causing painor hyperalgesiaan increased sensitivity to normally painful stimuliPN can significantly affect quality of lifeIt is estimated thatinAmericansi eM ofMsuffer from PNCurrentlythe most effective treatment of PN is pharmacological therapyHoweveronlyof patients achieve clinically meaningful reliefpartially due to various types of neuropathy not being affected by ordinary analgesicsMany treatments cause debilitating side effects due to their administration methode ggastrointestinalor the high levels of systemic uptake required to achieve effectAlternative localized drug therapies do existbut many have drawbacks to their administration methodsNeedle injections cause acute painwhile topically applied pain medications are limited by their molecular size since skin is virtually impermeable to molecules larger thanDaltonsA device is needed that can deliver PN medications to targeted areas through the skinquickly and efficientlyregardless of molecular sizeHypothesisLTA demonstrates feasibility of a hybrid US iontophoresis topical PN treatment to efficiently deliver clinically relevant dosages of gabapentin fromsolution into porcine skin in vitroleading to pre clinical and clinical testing in Phase IIAimLTA US component permeabilizes skinminutesand iontophoresis component accurately predicts skin permeabilization in vitro via secondary use as skin impedance measurement toolAimFifteen minute operation of LTA in dual mode delivers andgtof gabapentin dose into fullthickness porcine skin in vitro Project NarrativeRelevancePeripheral neuropathyPNis a series of disorders due to damage to the nervous system from lesion or diseaseCurrentlythe most effective treatment for theM Americans suffering from PN is oral medicationHoweveronlyof patients achieve clinically meaningful reliefand many drugs cause significant side effects due to systemic actionA transdermal patch is needed that can efficiently deliver PN medications directly through the skin to the targeted nerve areasmaximizing drug delivery and effect while also minimizing drug loading for both post use safety and potential for misuse