FDA Awards NeuroHealing Grant to Test TBI Treatment
NeuroHealing Pharmaceuticals is a company that develops products for individuals with traumatic brain injuries. The Food and Drug Administration recently awarded the company a three-year grant of $1,044,000 for the clinical development of NH001 from its Office of Orphan Products Development. The OOPD of the FDA is dedicated to promoting the development of products that demonstrate promise for the treatment of rare diseases or conditions. The NH001 product is currently in a phase IIa clinical trial attempting to improve the functional outcome of patients in a vegetative or minimally conscious state following a severe TBI. In the previous phase trials, the product has shown promising results and has received authorization from the FDA to begin an additional double blind Phase IIb clinical trial. Dr. Elkan Gamzu, acting Head of Clinical Trials at NeuroHealing, said, “This grant will provide the initial funding to begin the clinical program at the Spaulding Rehabilitation Hospital, a Harvard Medical School affiliated hospital and one of the leading rehabilitation facilities in the U.S., and will enable the continued development of this treatment which may offer patients, their families and physicians a new therapeutic option to help brain injured patients in an altered consciousness state.”
