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Emylif is bioequivalent and has a similar safety profile to unmodified riluzole tablets

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1. Di Stefano, et al. 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. 2022;8(1). Currently in press. 2. Emylif. Summary of Product Characteristics

Emylif is systemically absorbed almost identically to riluzole tablets (Di Stefano et al, 2022)

Di Stefano et al found that riluzole bioavailability after a single dose of ROF was equivalent to that of film-coated tablets in both rate and extent of absorption, thus fully statisfying the bioequivalence criteria (Di Stefano et al, 2022).

 

Riluzole plasma concentrations were almost superimposable between the different formulations, with a similar peak of riluzole concentration levels following both treatments (Di Stefano et al, 2022).

Emylif showed 109% AUC and 115% Cmax of Rilutek (Di Stefano et al, 2022).

The test treatment showed good tolerability similar to the reference and is expected to improve the patients’ compliance (Di Stefano et al, 2022).

Mean (+SD) plasma riluzole concentrations (mg/mL) vs time profiles after single dose of test and reference

Linear scale. N=102 (healthy volunteers). Single-center, single-dose, open-label, randomised, 2-sequence, 4-period replicate cross-over study comparing the pharmacokinetic profile of riluzole after replicate single dose of Emylif oral film against reference film-coated tablets to evaluate their bioequivalence in healthy men and women.

Adapted from Di Stefano et al, 2022

Efficacy

Emylif has a safety profile similar to unmodified riluzole tablets (Emylif SmPC, Di Stefano et al, 2022)

  • No risk of aspiration, contamination or underdosing associated with crushed tablets (Dyer et al, 2017)

  • No serious events or clinically meaningful effects on vital signs, body weight, mouth conditions or laboratory parameters were found in the bioequivalence study of healthy volunteers (Di Stefano et al, 2022)

  • Oral hypoesthesia occured in all subjects receiving Emylif, but it was mild and transient (Di Stefano et al, 2022)

  • No decline in swallowing function was detected after taking Emylif (Data on file NDA 212640)

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Single-center, single dose, open label, randomised, 2-sequence, 4-period replicate cross-over study comparing the pharmacokinetic profile of riluzole after replicate single dose of emylif oral film against reference film-coated tablets to evaluate their bioequivalence in healthy men and women (Emylif SmPC).

In phase III clinical studies conducted in ALS patients treat with riluzole, the most commonly reported adverse reactions were asthenia, nausea and abnormal liver function tests (Emilyf SmPC).

*Observed in an open-label pharmacokinetic study in healthy subjects (Emilyf SmPC).

Safety

Patient preference study results suggest Emylif could improve treatment satisfaction and adherance (Data on file EN011, 2022)

A study conducted by Zambon revealed that, more than 50% of patients using riluzole tablets crushed them (Data on file EN011, 2022).

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The study revealed that more than 60% of the time a dose is postponed or skipped. 

 

This was mainly due to difficulties with swallowing (32%) or in taking the treatment by themselves (29%).

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The study also showed that treatment satisfaction decreases with the need for alternation.

The satisfaction decreased with the increase in treatment manipulation and was the lowest in patients that always have to alter the formulation.

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Consistent with these findings, patients reported a high interest for a new product that could be easier and more convenient.

 

These results further indicate that ROF could indeed aid adherence to treatment.

(Data on file EN011, 2022)

Taken together these results suggest that patients are moderately satisfied with the current formulations and that ROF could improve treatment satisfaction and therefore adherence to treatment (Data on file EN011, 2022).

Patient preference

References

Di Stefano, et al. 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. 2022;8(1). Currently in press

Emylif. Summary of Product Characteristics

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

Data on File. Riluzole Oral Film, NDA 212640. Clinical Study Report.

Data on File: EN011. Price opportunity assessment and market access strategy for Riluzole Oral Film (ROF) – patient preference study in DE, ES, IT. Final Report 17 Aug 2022

GB_ROF_031

April 2023

Adverse event reporting
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