The Food & Drug Administration announced the approval of a new form of riluzole to be marketed as a treatment for ALS yesterday, called Tiglutik. Tiglutik is a nectar-like substance with riluzole suspended within. The drug will be marketed and produced by ITF Pharma, a U.S.-based subsidiary of the European pharmaceutical company Italfarmaco. ITF Pharma said in a press release that they will have Tiglutik available for purchase by the middle of next month (October 2018).
Riluzole was first approved by the FDA in 1995 as a marketable treatment for ALS under the brand name Rilutek. Clinical trials of the original pill-based formulation showed that people with ALS who took riluzole pills had a slower disease progression and survived several months longer, on average in some cases, than those in the placebo group. ITF Pharma makes no claims in its filing with the FDA that a person with ALS will have a slower disease progression if they take riluzole via their oral formulation versus the pill form. Rather, this novel riluzole suspension will make it possible for some people with ALS, that couldn’t try riluzole before, now to be able to do so. The data from the original clinical trials on riluzole and a summary of other research related to Tiglutik is published in the approved FDA drug label for Tiglutik.
While riluzole has been considered by many to be part of the standard of care for ALS for decades, many people with ALS aren’t able to try it due to worries about liver toxicity or because of the early onset of dysphagia (difficulty swallowing). Tiglutik was designed by ITF Pharma to address the dysphagia issue faced by many people with ALS, specifically those with bulbar onset ALS or those with prevalent bulbar symptoms. People with ALS who have developed difficulty swallowing may find it easier to swallow this liquid formulation of riluzole rather than the pills. This may enable people who otherwise couldn’t try riluzole at the time of their ALS diagnosis to do so. It may also help people to stay on riluzole longer as dysphagia does develop further along as part of ALS disease progression.
ITF Pharma has created a branded website for Tiglutik with more information about when it will be available, and how to take it. In the UK, the oral formulation is sold under the brand name Teglutik by Martindale Pharma.
More information about the recent marketing approval of Tiglutek (riluzole) in the US will be discussed during a webinar being held by ALS TDI on late stage drug development projects in ALS on September 25.