UPDATE: FDA Grants Orphan Drug Status to Metadoxine in Fragile X Syndrome
Alcobra (Nasdaq: ADHD) announced today that the U.S. Food & Drug Administration has granted "Orphan Drug" designation to Metadoxine in the treatment of Fragile X Syndrome. The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. Orphan designation qualifies the sponsor of the drug for various development incentives of the ODA, as well as an extended period of market exclusivity following approval.
"We are pleased that the FDA has granted Orphan Drug status to Metadoxine, the active ingredient in MG01CI, in Fragile X," said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra Ltd. "We recently achieved positive results from a preclinical study of Fragile X and believe this outcome supports investigation in clinical trials which we plan to initiate in 2014. We recently raised approximately $38 million in a secondary offering, and we believe we now have enough cash to fund the Company through planned submissions