Bioequivalent to riluzole tablets (RILUTEK®)1-3

EXSERVAN (riluzole) demonstrated bioequivalence to riluzole oral tablets (RILUTEK) (when swallowed whole) and showed a similar rate of absorption.1-3

EXSERVAN was approved based on a relative bioavailability and food-effect study in healthy subjects comparing RILUTEK to EXSERVAN oral film.1

  • Consistent with riluzole tablets, EXSERVAN was found to have reduced bioavailability if administered with food1,3
  • A high-fat meal reduced the AUC of EXSERVAN by 15% and reduced the Cmax by 45%1

EXSERVAN bioavailability and bioequivalence studies4

EXSERVAN™ Bioequivalence Studies

Study Design

In a single-center, open-label, single-dose, randomized, 5-period, crossover, comparative bioavailability study, healthy participants (n=32), under fasting conditions, were randomized to receive EXSERVAN (riluzole) or RILUTEK.4

Riluzole increases the time to tracheostomy or death in patients with ALS vs placebo3

Since 2009, the American Academy of Neurology (AAN) Guidelines have recommended offering riluzole to slow disease progression in patients with ALS.5,6

In fact, 7 out of 10 patients newly diagnosed with ALS are prescribed riluzole each year.7,a

aAs based on IQVIA/NBRX data 01/20-12/20.

Two pivotal clinical trials found that riluzole, compared with placebo, increased the time to death or tracheostomy in patients with ALS.3

  • The Kaplan-Meier plots show that the time to tracheostomy or death was longer for patients taking riluzole who reached the endpoint compared to those who received placebo3

Chart displaying the effect of one 50-mg riluzole tablet taken twice daily in Study 1.

Original RILUTEK study design 13

Study 1 was a randomized, double-blind, placebo-controlled clinical study that enrolled 155 patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity ≥ 60% of normal. Patients were randomized to receive riluzole 50 mg tablets twice daily (n=77) or placebo (n=78) and were followed for at least 13 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.


Chart displaying the effect of one 50-mg riluzole tablet taken twice daily in Study 2.

Original RILUTEK study design 23

Study 2 was a randomized, double-blind, placebo-controlled clinical study that enrolled 959 patients with either familial or sporadic ALS, a disease duration of less than 5 years, and a baseline forced vital capacity ≥ 60% of normal. Patients were randomized to riluzole 50 mg tablets twice daily (n=236) or placebo (n=242) and were followed for at least 12 months (up to a maximum duration of 18 months). The clinical outcome measure was time to tracheostomy or death.

Safety and tolerability similar to riluzole tablets (RILUTEK)1,3

Adverse reactions in pooled placebo-controlled trials (studies 1 and 2) in patients with ALS1

  • In clinical trials, the most common adverse reactions (≥5%) were asthenia, nausea, decreased lung function, hypertension, and abdominal pain1
  • The most common adverse reactions leading to discontinuation were nausea, abdominal pain, constipation, and elevated alanine aminotransferase1
  • In a clinical trial of healthy subjects, 38% of subjects taking EXSERVAN experienced oral hypoesthesia, compared with no subjects taking riluzole tablets, under fasting conditions1

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    References:
  1. EXSERVAN (riluzole) Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2021.
  2. Center for Drug Evaluation and Research (US). 2017. EXSERVAN (riluzole). Washington DC: US Food and Drug Administration, Center for Drug and Evaluation Research. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212640Orig1s000MedR.pdf. Accessed April 2, 2021.
  3. RILUTEK® (riluzole) Prescribing Information. Cary, NC: Covis Pharmaceuticals Inc.; 2016.
  4. Center for Drug Evaluation and Research (US). 2019. EXSERVAN (riluzole). Washington DC: US Food and Drug Administration, Center for Drug and Evaluation Research. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212640Orig1s000ClinPharmR.pdf. Accessed April 19, 2021.
  5. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009;73(15):1218-1226.
  6. Miller RG, Jackson CE, Kasarskis EJ, et al. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: multidisciplinary care, symptom management, and cognitive/behavioral impairment (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009;73(15):1227-1233.
  7. Data on File. Mitsubishi Tanabe Pharma America, Inc., Jersey City, NJ.