EG-1962 (nimodipine microparticles)

EG-1962 (nimodipine microparticles) is being developed to reduce ischemic deficits and improve outcomes in patients suffering SAH who undergo endovascular coiling or surgical clipping and those suffering traumatic brain injury (TBI). EG-1962 (nimodipine microparticles) is a proprietary formulation of the FDA-approved drug nimodipine, a calcium channel blocker, encapsulated in biodegradable polymer and mixed with a hyaluronic-based buffer making a suspension that releases nimodipine over 14 days. EG-1962 (nimodipine microparticles) will be able to be delivered in two different ways. It can be delivered minimally invasively through an existing external ventricular drain (EVD) after the patient has undergone endovascular coiling to secure the bleeding aneurysm or after TBI. Since the EVD is already in place to monitor brain pressure, there is no additional procedure required. Another method will be to implant the nimodipine microparticles directly into the basel cisterns in the cisterna magna of the brain at the injury site during surgical clipping. It will be delivered locally during the surgical clipping, so there is no additional procedure required. EG-1962 (nimodipine microparticles) is expected to provide therapeutic and sustained concentrations of nimodipine to the site of brain injury to prevent delayed cerebral ischemia (DCI) while minimizing side effects. DCI may develop in these patients due to a number of mechanisms including cerebral vasospasm, cortical spreading ischemia, and microthrombembolism. Since oral nimodipine was FDA approved in 1989, nimodipine has been given universally to SAH patients in oral or intravenous form to improve outcome, but it is only marginally effective because it does not achieve high enough (more therapeutic) drug concentrations at the site of brain injury to more effectively block the pathways leading to DCI. Higher dosages of nimodipine that might be more effective in the brain cause dangerous side effects in other parts of the body such as low blood pressure (hypotension) and lung complications. EG-1962 (nimodipine microparticles) is designed to overcome the limitations of systemic nimodipine and accommodate the shifting market treatment dynamics away from microsurgical clipping to endovascular coiling.