WASHINGTON, Sept. 12, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the
results of a HETLIOZ® (tasimelteon) driving study to
measure next day performance. Tasimelteon did not impair
measures of driving performance, whereas the active control,
zopiclone, showed significant impairment.
In this triple crossover study, 48 healthy volunteers drove 100
km in a validated driving simulator the morning after taking a
bedtime dose of either tasimelteon 20 mg, zopiclone 7.5 mg or
placebo. The volunteers were instructed to operate the
driving simulator for approximately 1 hour with a speed of 55 mph
while maintaining lane position.
Treatment with tasimelteon 20 mg at bedtime demonstrated no next
day driving impairment compared to placebo. Treatment with
zopiclone 7.5 mg dosed at bedtime was associated with a meaningful
and significant increase in Standard Deviation of Lateral Position
(SDLP), a measure of lane weaving, compared to the placebo
treatment. Results for SDLP, the primary endpoint, are shown
below.
Driving Study Results Summary
Treatment
Comparison
|
SDLP Difference*
(cm)
|
95% CI
|
p-value
|
Tasimelteon vs
Placebo
|
1.22
|
(-0.29,
2.74)
|
p=0.1119
|
Zopiclone vs
Placebo
|
4.14
|
(2.60,
5.68)
|
p<0.0001
|
Tasimelteon vs
Zopiclone
|
-2.92
|
(-4.43,
-1.41)
|
p=0.0002
|
*Least squares
means
|
A secondary analysis of the paired differences between
treatments (a symmetry analysis) confirmed that tasimelteon did not
impair next day driving while there was an impairment with
zopiclone. A difference of 4.4 cm is considered equivalent to
the driving impairment associated with a blood alcohol (BAC) level
of 0.05%, a level associated with increased crash
risk.1
"Compared to other sleep agents where we've investigated
next-day residual effects on driving, tasimelteon demonstrated no
impairment when evaluated 9 hours after dosing," said Gary G. Kay, Ph.D., President of Cognitive
Research Corporation, the contract research organization who ran
the study. Dr. Kay serves as a consultant for the National
Highway Transportation Safety Administration (NHTSA) and is a
recognized expert in drug impaired driving.2
HETLIOZ® is currently approved for the treatment of
Non-24 Hour Sleep Wake Disorder. Vanda plans to file a
supplemental New Drug Application for HETLIOZ® for the
treatment of Jet Lag Disorder with the FDA in 2018. For a review of
the current prescribing information of
HETLIOZ® please visit www.hetlioz.com.
HETLIOZ® IS NOT CURRENTLY APPROVED BY ANY
REGULATORY AUTHORITY FOR THE TREATMENT OF JET LAG DISORDER.
About Zopiclone
Zopiclone is a non-benzodiazepine sleep agent marketed at a dose
of 7.5 mg in countries outside the U.S. In the U.S.,
eszopiclone the s-enantiomer of zopiclone, is available under the
brand name Lunesta®.
About Driving Safety and Sleep Promoting Agents
Next day driving impairment has been reported for a number of
sleep promoting agents including Ambien (zolpidem), the most
commonly used prescription drug in the class,3 as well
as for the most commonly used over the counter sleep aids
containing diphenhydramine (e.g., Excedrin
PM®).4
About HETLIOZ®
HETLIOZ® is a melatonin receptor agonist.
HETLIOZ® has been granted market authorization by
the U.S. Food and Drug Administration and the European Medicines
Agency. For full U.S. prescribing information, please
visit www.hetlioz.com.
Important Safety Information
The most common adverse reactions (incidence >5% and at least
twice as high on HETLIOZ® (tasimelteon) than on
placebo) were headache, increased alanine aminotransferase,
nightmares or unusual dreams, and upper respiratory or urinary
tract infection. The risk of adverse reactions may be greater in
elderly (>65 years) patients than younger patients because
exposure to HETLIOZ® is increased by approximately
2-fold compared with younger patients.
Indication
HETLIOZ® is indicated for the treatment of
Non-24-Hour Sleep-Wake Disorder (Non-24).
Important Safety Information
HETLIOZ® may cause somnolence: After taking
HETLIOZ®, patients should limit their activity to
preparing for going to bed, because HETLIOZ® can
potentially impair the performance of activities requiring complete
mental alertness.
The most common adverse reactions (incidence >5% and at least
twice as high on HETLIOZ® than on placebo) were
headache, increased alanine aminotransferase, nightmares or unusual
dreams, and upper respiratory or urinary tract infection. The risk
of adverse reactions may be greater in elderly (>65 years)
patients than younger patients because exposure to
HETLIOZ® is increased by approximately 2-fold
compared with younger patients.
Use of HETLIOZ® should be avoided in combination
with fluvoxamine or other strong CYP1A2 inhibitors, because of a
potentially large increase in exposure of HETLIOZ®, and
a greater risk of adverse reactions.
HETLIOZ® should be avoided in combination with
rifampin or other CYP3A4 inducers, because of a potentially large
decrease in exposure of HETLIOZ®, with reduced
efficacy.
There are no adequate and well-controlled studies of
HETLIOZ® in pregnant women. Based on animal data,
HETLIOZ® may cause fetal harm.
HETLIOZ® should be used during pregnancy only if
the potential benefit justifies the potential risks. Caution should
be exercised when HETLIOZ® is administered to a
nursing woman.
HETLIOZ® has not been studied in patients with
severe hepatic impairment and is not recommended in these
patients.
Safety and effectiveness of HETLIOZ® in
pediatric patients have not been established.
About Vanda
Vanda is a global biopharmaceutical company focused on the
development and commercialization of innovative therapies to
address high unmet medical needs and improve the lives of patients.
For more on Vanda Pharmaceuticals Inc., please
visit www.vandapharma.com.
Abbreviations
SDLP
|
Standard Deviation of
Lateral Position
|
CI
|
Confidence
Interval
|
References
- Compton, R. P. & Berning, A. (2015, February). Drug and
alcohol crash risk. (Traffic Safety Facts Research Note. DOT HS 812
117). Washington, DC: National
Highway Traffic Safety Administration.
- Kay, G. G., & Logan, B. K., (2011). Drugged Driving Expert
Panel report: A consensus protocol for assessing the potential of
drugs to impair driving. (DOT HS 811 438).
- Farkas, R.H., Unger, E.F., Temple, R. (2013).
Zolpidem and Driving Impairment — Identifying Persons at
Risk. N ENGL J MED 369;8.
- Kay, G.G., Schwartz, H.I., Wingertzahn, M.A., Jayawardena, S.,
Rosenberg, R.P. (2016). Next-day residual effects of gabapentin,
diphenhydramine, and triazolam on simulated driving performance in
healthy volunteers: a phase 3, randomized, double-blind,
placebo-controlled, crossover trial. Hum. Psychopharmacol
Clin Exp.
HETLIOZ® is Vanda's registered trademark. Any other
trademarks, registered marks and trade names and service marks
appearing in this release are the property of their respective
holders.
Company Contact:
Jim Kelly
Executive Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.