The U.S. Food and Drug Administration granted a Main Line biotech company “Fast Track” status for a synthetic cannabidiol drug that is intended to treat symptoms associated with the genetic condition Fragile X.
Zynerba Pharmaceuticals of Devon announced Monday morning that it had won the status for its Zygel transdermal CBD lotion. Fast Track designation speeds up the review of drugs that treat an unmet medical need. There currently are no drugs to treat the symptoms of Fragile X syndrome, which include developmental problems from learning disabilities to cognitive impairment. Zynerba is in the final stages of a clinical trial of Zygel and hopes to have it on the market by late 2020, said spokesman Will Roberts.
Shares in the biotech (NASDAQ: ZYNE) were up more than 11 percent on Monday and closed at $12.76.
Zygel is primarily targeted for Fragile X, which is said to affect one in 4,000 males and one in 6,000 girls. It also could be deployed for children with autism spectrum disorders who suffer from similar anxiety and behavioral problems.The FDA already had granted the gel orphan-drug status, which gives Zynerba a seven-year period to market the drug exclusively in the U.S. as well as granting the company tax credits for clinical research expenses.