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Localized medical conditions are
often treated with systemic therapies, especially when the anatomical
site of the disorder is difficult to access. The cochlea, the
believed origin site of peripheral tinnitus, is a difficult anatomical
site to reach. There is no convenient way to effectively deliver
drug directly into the cochlea. Providing an effective treatment
to the cochlea requires a potent therapeutic to minimize the volume of
drug required along with a specialized drug delivery system.
 A specialized drug delivery system will enable drug
delivery to this difficult site on a continuous basis. Systemic
delivery or injections to local sites near the desired delivery tissue
are not feasible or effective. NeuroSystec’s first product will
be a fully implantable drug delivery system with a specialized pump
that will deliver a potent drug through a catheter into the
cochlea. The drug will be taken from an internal reservoir and
delivered to the target tissue in the scala tympani, the site of the
tinnitus. As tinnitus is a chronic disease requiring
continuous drug delivery, this delivery system will be able to deliver
drug for a year or longer without requiring refilling or
replacement. Such a delivery system will overcome the anatomical
limitations and place a highly potent therapeutic on the diseased
tissue.
Tissue specific delivery allows for the use of agents with greater
potency while minimizing the risk of systemic side effects. In
treating localized conditions systemically, a choice must often be made
to use drugs that are less effective yet offer fewer side
effects.
NeuroSystec is currently developing a potent and highly specific NMDA
receptor antagonist (NST-001) with little AMPA receptor activity for
severe, peripheral tinnitus. This compound is a mixed agonist and
antagonist of the NMDA receptor which gives it the ability to mitigate
the undesirable activity without modifying the desirable
activity. This compound has been found to be active in animal
models for tinnitus. In clinical trials for other therapeutic
areas it has been found to be safe in humans.
To date there is no effective therapeutic for tinnitus that has been
approved by the FDA. NeuroSystec expects that this
combination of an implantable, drug-delivery device and a highly potent
therapeutic will have a profound effect on the management of tinnitus
if it proves successful in clinical studies.
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