Emylif – orodispersible film for ALS

Posted on 24 January, 2024 - Amyotrophic Lateral Sclerosis (ALS)

  • Orodispersible film formulation of disease-modifying drug riluzole now available to ALS patients in the UK
  • Emylif offers an alternative for the 80% of patients who experience difficulty swallowing during the course of their disease1

January 24, 2024: In November 2023, Zambon UK launched Emylif, a new formulation of riluzole in an orodispersible film – for the treatment of adults with amyotrophic lateral sclerosis (ALS).  Emylif offers an alternative to the tablet administration of riluzole which can be difficult for patients to take as their disease progresses and they develop dysphagia (difficulty swallowing). Dysphagia occurs in around 80% of ALS patients over the course of their disease1.

Emylif is applied to the tongue and allowed to dissolve, with no need for water, tongue mobility or muscular strength. Studies have demonstrated that this mode of administration is bioequivalent to the tablet form of riluzole.2

Riluzole is the only disease-modifying treatment available to ALS patients in the UK. Currently, it is common practice for carers to crush riluzole tablets in order to administer them to patients who are finding it difficult to swallow tablets.3 Emylif offers a licenced alternative for these patients.

The safety profile of Emylif is very similar to that of other riluzole formulations, with the exception of oral hypoesthesia (numbness in the mouth). It is common for patients to experience mild and transient oral hypoesthesia which can last for an average of around 40 minutes.5 In a small-scale study in ALS patients there was no detrimental effect on swallowing following a single dose of riluzole orodispersible film.6 It is suggested that patients are counselled on the risk of numbness in the mouth so that they are not surprised or concerned if this occurs. 

References

  1. Muscaritoli M, Kushta I, Molfino A, Inghilleri M, Sabatelli M, Rossi Fanelli F. Nutritional and metabolic support in patients with amyotrophic lateral sclerosis. Nutrition (2012) 28(10):959-66. doi:10.1016/j.nut.2012.01.011
  2. Di Stefano AFD, Radicioni MM, Segantin A, Gentili A, Baroglio C, Marjanović I, Cattaneo C (2022) Randomised, 2-Sequence, 4-Period Replicate Cross-Over Bioequivalence Study of a New Riluzole Orodispersible Film Vs. A Reference Tablet in Healthy Volunteers. J Bioeq Stud 8(1): 101
  3. Dyer AM, Smith A. Riluzole 5 mg/mL oral suspension: for optimized drug delivery in amyotrophic lateral sclerosis. Drug Des Devel Ther. 2017;11:59-64. https://doi.org/10.2147/DDDT.S123776
  4. Thong MY, Manrique YJ, Steadman KJ. Drug loss while crushing tablets: Comparison of 24 tablet crushing devices. PLoS One. 2018 Mar 1;13(3):e0193683. doi:10.1371/journal.pone.0193683. PMID:29494695; PMCID: PMC5832315
  5. Emylif Summary of Product Characteristics
  6. Wymer J, Apple S, Harrison A, Hill BA. Pharmacokinetics, Bioavailability, and Swallowing Safety With Riluzole Oral Film. Clin Pharmacol Drug Dev 2023 Jan;12(1):57-64.doi:10.1002/cpdd.1168