The pharmaceutical company Neurelis Inc. recently announced that the US Food and Drug Administration (FDA) has granted fast-track designation for NRL-1, a special formulation of diazepam, for the treatment of epilepsies that are characterised by clusters of seizures. This means that the new formulation could become available more quickly.”We are very excited to have received Fast Track Designation status with the FDA,” said Craig Chambliss, President and Chief Executive Officer of Neurelis, in a press release. “We are looking forward to working with the FDA as we complete our clinical development work….. and prepare for the commercialization of NRL-1. We are focused on providing epilepsy patients and health care providers with an effective, well-tolerated, and user-friendly product for the treatment of acute repetitive or cluster seizures.”Diazepam is a drug used to treat anxiety, alcohol withdrawal, muscle spasms, and some types of seizures. NRL-1 is a diazepam nasal spray, which is being developed for the treatment of children and adults with epilepsy who require recurrent use of the drug to control bouts of acute repetitive seizure activity, also known as cluster seizures.Previous clinical studies have shown that NRL-1 is generally safe and well tolerated and that there is little variability from dose to dose. The new formulation is in its final stage of clinical testing, after which the company will submit a New Drug Application (NDA) to the FDA requesting marketing authorisation for NLR-1. The company says that they plan to market NRL-1 worldwide.For many years, the only treatment option for people with cluster seizures was to administer diazepam rectally, which was challenging under some circumstances. That changed with licensing of buccal midazolam in the UK in 2011. It is hoped that NRL-1 will offer a further treatment option for people with cluster seizures and allow the delivery of a therapeutic dose of diazepamvia a nasal spray rapidly and easily in many settings.Please note that Epilepsy Research UK does not endorse/promote individual epilepsy treatments or pharmaceutical companies.Author: Dr Özge ÖzkayaClick here for more articles about anti-epileptic drugs and pregnancy risks.
January 10th, 2017|