Two new drugs targeting the main symptoms of autism have been bumped into the fast lane for testing and approval within the next year. While this is great news, because of the long and arduous process of getting new pharmaceutical drugs to market, it’s not likely that you’ll be seeing these drugs on pharmacy shelves anytime soo
Balovaptan Thought to Improve Communication and Social Skills for Individuals with Autism
Drugmaker Roche is working on an autism medication called Balovaptan, which supposedly helps to improve social skills and communication for individuals with autism. This drug achieves this outcome by targeting a certain hormone that is tied to behavior. The drug has recently received what’s called a “breakthrough” therapy designation from the FDA which simply means that there has been evidence that shows the drug could offer some form of clinical benefit. Clinical trials are currently being conducted for children, teens, and adults with autism.
L1-79 Medication from Yamo Pharmaceuticals Has Also Received Favorable Designation from the FDA
The FDA also provided Yamo Pharmaceuticals with a “fast track” designation for its autism medication called L1-79, which helps to improve socialization and speech by targeting the central nervous system. It’s important to keep in mind that receiving a “fast track” designation is a significant breakthrough for this drug because it means that Yamo has a lower standard to meet compared to other drugs seeking FDA approval. All that is required for this drug to come to market is that it successfully treats a serious condition, in this case, autism and that it fills a currently unmet need in the medical market. According to Yamo’s management, if all goes well regarding meetings with the FDA, the company plans to start a clinical trial in early 2019.
FDA Designations are Significant, But Hard Work is Still Ahead
While these FDA designations for both of these drugs are quite significant and show significant promise, both are still in their infancy in terms of the many hurdles related to getting these medications to market. At Perspectives Counseling Centers, we’re constantly monitoring new developments in the treatment for autism, both from a counseling perspective as well as through medication treatment. If you or a loved one has autism, and you’re interested in learning more about our approach to treatment, feel free to reach out to our team today.