Spinethera, Inc. — Department of Health and Human Services SBIR Phase I: NIAMS

Description

DESCRIPTION provided by applicant Back pain is a pervasive health problem and a significant area of healthcare expenditure Epidural steroid injections ESI are commonly given to treat back pain after more conservative treatment options have failed ESIandapos s are expensive and short lasting Repeat injections are common over the first months of treatment All are done off label with generic injectable steroids Physicians historically preferred the water insoluble steroid suspensions such as methylprednisolone acetate to prolong the duration of steroid exposure compared to a water soluble steroid Recently the water insoluble steroid suspensions have been linked to paralysis or death after failed epidural injections that resulted in delivery to an artery that passes through the epidural space and which supplies blood to the spinal cord The particles in these water insoluble steroid suspensions are significantly larger than capillary beds and are believed to result in vascular occlusion Researchers have replicated a direct arterial injection in pigs and have shown that such an injection leads to neurological injury with a water insoluble steroid suspension but not with a water soluble steroid solution SpineThera aims to demonstrate feasibility of a sustained release biodegradable microparticle steroid formulation that will not result in vascular occlusion if inadvertently injeced into a spinal artery Such a formulation may eliminate the need for repeat ESIandapos s over the drug release time period or longer and eliminate the risk of paralysis associated with some generics The duration of drug release is intended to be significantly longer than from the generic water insoluble steroid suspensions SpineThera proposes to utilize previously established in vitro drug release tests that have been compared to in vivo release profiles to demonstrate that days of drug release can be achieved from a biodegradable microparticle formulation whose particle size is small enough to not lead to direct capillary bed occlusion Variables such as biodegradable polymer chemistry microencapsulation processing technique and physical form of the active pharmaceutical ingredient will be studied utilizing a Quality by Design approach The biodegradable microparticles will further include a surface modification intended to prevent agglomeration and platelet adhesion Formulations that meet the day drug release particle size non aggregating and surface chemistry criteria will be further studied The selected formulations will be given as a direct injection into a spinal artery of a pig n Vascular occlusion will be assessed by angiography and compared to injections of a water insoluble steroid suspension which has shown occlusion in previous study and a water soluble steroid solution non occluding in previous study PUBLIC HEALTH RELEVANCE The proposed drug may eliminate the need repeat for epidural steroid injections to treat back pain Direct healthcare spending may be reduced by $ billion more than Furthermore the proposed drug may eliminate the risk of paralysis that has been documented with epidural injection of some generic steroids