Devon-based Zynerba Pharmaceuticals has received “Fast Track” status from the FDA for its synthetic cannabidiol drug intended to treat symptoms associated with Fragile X, writes Sam Wood for the Philadelphia Inquirer.
The symptoms include developmental problems that range from learning disabilities to cognitive impairment.
The biotech company won the “Fast Track” status for Zygel, a transdermal CBD lotion. The status speeds up the review process for drugs that are meant to treat an unmet medical need. Currently, there are no drugs that treat symptoms of Fragile X syndrome.
While the drug is primarily targeted for Fragile X, which affects one in 4,000 boys and one in 6,000 girls, it could also be used for children on the autism spectrum who suffer from similar problems.
Zynerba is currently in the final stages of a clinical trial of Zygel. The company hopes to have it on the market by late next year. Its shares jumped by more than 11 percent following the announcement.
The FDA has previously granted Zygel orphan-drug status, giving the company seven years to market the treatment exclusively within the country and granting it tax credits for clinical research expenses.
Read more about Zynerba Pharmaceuticals in the Philadelphia Inquirer here.