Israeli drug developer Alcobra Ltd. (Nasdaq: ADHD), today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to Metadoxine Extended Release (MDX) for the treatment of Fragile X Syndrome. Alcobra develops treatments for Attention Deficit Hyperactivity Disorder (ADHD), Fragile X Syndrome, and other cognitive disorders.
Alcobra president and CEO Dr. Yaron Daniely said, “We are pleased that the FDA has recognized the potential of MDX in Fragile X Syndrome and granted Fast Track designation for this indication. We look forward to our upcoming meeting with the FDA to determine next steps in advancing the development program for MDX in this area of serious unmet medical need.”
Fast Track designation is a process designed to facilitate the development and expedite the review of drugs that demonstrate the potential to address unmet medical needs in serious or life-threatening diseases or conditions. According to FDA, a disease or condition is considered serious based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe to a more serious condition.
Companies that receive Fast Track designation can have more frequent interactions with the FDA review team to facilitate product development. In addition, based on clinical data, the New Drug Applications (NDA) for these products could be eligible for priority and/or rolling review.
In 2013, the FDA granted orphan drug status to metadoxine for the treatment of Fragile X Syndrome. Currently, there are no FDA approved medications for Fragile X Syndrome. Fragile X Syndrome (FXS) is a genetic condition that causes intellectual disability, behavioral and learning challenges and is the leading known genetic cause of autism, accounting for about 2-6% of cases.
Published by Globes [online], Israel business news - www.globes-online.com - on September 21, 2015
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