VistaGen Therapeutics has recently been cleared by the FDA to begin the second phase of their study of AV-101, which is intended for the treatment of dyskinesia in those affected by Parkinson’s disease. Dyskinesia, which is the involuntary muscle movements that characterize Parkinson’s disease, is in need of a new treatment, as current medications often result in hallucinations and sedation. Not only has the FDA cleared VistaGen’s Investigational New Drug application, but the U.S. Patent and Trademark Office has allowed for a patent of this treatment, which will be in effect until 2034.
About Parkinson’s Disease
Parkinson’s disease is a progressive disorder that affects the central nervous system (CNS). It is characterized by its effect on movement through five different stages. As the disease progresses, severity increases. Stage one is characterized by subtle tremors on one side of the body. In stage two symptoms are more noticeable, with tremors and rigidity on both sides of the body. Stage three brings loss of balance and slow movement, while stage four makes it impossible for one to live independently. Stage five is the most severe, as patients cannot stand or walk. Hallucinations and delusions are common symptoms of this stage.
Parkinson’s disease occurs due to the death of motor neurons, some of which produce dopamine. Dopamine is important in the transmittance of messages to the muscles from the brain, so the loss of dopamine results in the loss of motor functions. Abnormal brain activity occurs when these neurons are lost and leads to Parkinson’s. Doctors do not know why these motor neurons die, but they do suspect a few factors that play a role, such as genetics, environmental factors like toxins, and Lewy bodies.
There are no FDA approved therapies for Parkinson’s, and treatment is symptomatic. Treatment options include dopamine substitutes, carbidopa-levodopa, MAO-B inhibitors, catechol-O-methyltransferase (COMT) inhibitors, anticholinergics, and amantadine.
AV-101 is an investigational drug, and it belongs to a new class of medications called N-methyl-D-aspartate receptor (NMDAR) modulators. It is a receptor within the brain and it is being used to treat a multitude of central nervous system disorders. Av-101 is an oral treatment, and it is meant to be taken at-home and is non-sedating.
Past clinical research showed that this treatment is effective and does not bring the same adverse effects that other medications do. It was studied in non-human primate models and researchers used a parkinsonian disability scale to measure results.
Study of AV-101, Phase 2
The second phase of this study has been approved by the FDA after VistaGen Therapeutics sent in their Investigational New Drug application. Preclinical data showed positive results for the treatment of dyskinesia without the adverse effects of previous treatments.
Medical professionals hope that this phase is successful. AV-101 has an “exceptional safety profile,” giving it a lot of potential for a novel therapy for dyskinesia in those with Parkinson’s.
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