Amid government crackdowns on pharmaceutical companies and increasingly strict federal guidelines, two companies received positive feedback today on their treatments for depression and Vascular Ehlers-Danlos Syndrome (VEDS).
The FDA proposed some postmarketing requirements and commitments regarding Axsome’s New Drug Application (NDA) for its AXS-05 drug. Axsome has been working on AXS-05, a treatment for major depressive disorder, for years. Originally, the drug was created to treat other Central Nervous System (CNS) disorders. The drug first received an FDA Breakthrough Therapy designation as a treatment for Alzheimer’s disease agitation.
Another company that received good news from the FDA is Colorado-based Aytu BioScience. Aytu, a pharmaceutical company that develops novel therapeutics, announced that the FDA granted Fast Track designation to its AR101 drug, a protein kinase C (PKC) β inhibitor, as a treatment for patients with VEDS. With the designation, Aytu plans to enroll 260 VEDS patients in its PREVEnt Trial. Patients will be treated either with the current standard of care or with AR101. AR101 had already received Orphan Drug designation from the FDA, and it received the same designation in Europe from the European Medicines Agency. Read more here.