WASHINGTON, May 23, 2018 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced results
from the JET Study (VP-VEC-162-2102), a 3-night transatlantic
travel study of the effects of tasimelteon on Jet Lag Disorder.
Tasimelteon was shown to be effective in treating Jet Lag Disorder
in travelers who flew from the US to the UK.
"The results of the JET study are supportive and add to the body
of evidence of the effects of tasimelteon on Jet Lag in the context
of 5 and 8 hour time zone transatlantic travel," said Mihael H. Polymeropoulos, MD, Vanda's President
and CEO.
The JET study was a two-phase transatlantic travel study, with
an observational travel phase (baseline) followed by a treatment
phase. Study participants traveled either 5 or 8 time zones from
Washington, DC to London and San
Francisco or Los Angeles to
London, respectively. They stayed
in London for 3 nights and 4 days,
and during randomization they received tasimelteon 20mg for 3
consecutive nights prior to their bedtime. Efficacy was monitored
by polysomnography (PSG) as well as sleep and wake questionnaire
scales. Due to the complexity of the study, the study was
terminated before it reached the original enrollment goal of 90
patients, with only 25 patients completing both phases of the study
(tasimelteon n=13, placebo n=12).
Despite the small sample size (n=25) of this study, tasimelteon
succeeded in demonstrating significant and meaningful effects
across a number of sleep and wake measures, as summarized in Table
1.
Tasimelteon significantly improved total sleep time of the first
2/3 of the night (TST 2/3) on night 3, in both objective and
subjective measures of sleep. Tasimelteon-treated patients slept 76
minutes longer during their second trip as compared to their first.
Cumulatively over the 3 travel nights of their second trip,
tasimelteon-treated patients added 131 minutes of sleep (TST 2/3)
as compared to the 3 travel nights of the first trip.
Similar results favoring tasimelteon were seen in outcomes of
the Post Sleep Questionnaire (PSQ), including subjective TST,
subjective Sleep Latency, subjective Wake after Sleep Onset and
subjective Sleep Quality. Measures of global function, including
Patient Global Impression of Severity (PGI-S) and the Karolinska
Sleepiness scale (KSS), also favored tasimelteon.
Table 1: Summary of Results
|
Change from
baseline
|
|
|
|
Endpoint
|
HETLIOZ®
|
Placebo
|
Difference
|
p-value
|
|
Objective
Sleep
|
TST2/3
Night 3 *
|
76.2
|
41.4
|
34.8
|
p=0.0354
|
|
TST2/3 All
3 Nights
|
131.4
|
40.9
|
90.6
|
p=0.0785
|
|
Subjective
Sleep
|
TST Night
3
|
111.9
|
33.5
|
78.5
|
p=0.0225
|
|
TST All 3
Nights
|
240.0
|
65.1
|
174.9
|
p=0.0423
|
|
Sleep Quality (1-5)
Night 3
|
1.31
|
0.36
|
0.95
|
p=0.0198
|
|
Sleep Latency Night
3
|
-20.6
|
6.0
|
-26.5
|
p=0.0347
|
|
WASO Night
3
|
-81.1
|
-24.7
|
-56.4
|
p=0.0840
|
|
Global
Functioning
|
PGI-S (1-4) Day
3
|
-0.71
|
-0.07
|
-0.63
|
p=0.0168
|
|
KSS (1-9) Day
4
|
-1.69
|
-0.69
|
-1.00
|
p=0.0765
|
|
*The primary endpoint of the study was Total Sleep Time for the
first 2/3 (TST 2/3)2 of the night(s) most likely to be
disrupted. Examination of the observational phase baseline data
demonstrated that Night 3 was the night most disrupted with 197
minutes in TST 2/3, followed by Night 1 and Night 2 with 218
minutes and 250 minutes, respectively. TST, Sleep Latency, and WASO
shown in minutes.
The results of the JET study support the previously reported
pivotal JET5 and JET8 Phase III studies, which demonstrated
significant effects in circadian advances of 5 and 8 hours,
respectively.1,2
Jet Lag Disorder affects millions of individuals annually who
cross multiple time zones during their travel. Jet Lag Disorder
symptoms are more severe during eastward travel. It is
reported that more than 30 million US residents make trips abroad
each year to overseas destinations. Of these, 60% (approximately 20
million) travel to destinations in Europe, the Middle
East and Asia. It is also
reported that of these 20 million travelers, 8% (approximately 1.6
million) travel in either Business or First Class.3
Vanda intends to seek marketing approval for the use of
HETLIOZ® in the treatment of Jet Lag Disorder. Vanda
believes that if HETLIOZ® is approved by regulatory
authorities for the treatment of Jet Lag Disorder, it will
potentially offer a therapeutic solution to many travelers and may
represent an important commercial opportunity for the company.
Vanda plans to file a supplemental New Drug Application for the
treatment of Jet Lag Disorder with the FDA during the second half
of 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 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
PSG
|
Polysomnography
|
TST
|
Total Sleep
Time
|
TST2/3
|
Total Sleep Time
First Two Thirds
|
WASO
|
Wake After Sleep
Onset
|
PGI-S
|
Patient Global
Impression of Severity
|
KSS
|
Karolinska Sleepiness
Scale
|
References
1. Rajaratnam SM, Polymeropoulos MH, Fisher DM, Roth T, Scott C,
Birznieks G, Klerman E. Melatonin agonist tasimelteon
(VEC-162) for transient insomnia after sleep-time shift: two
randomized controlled multicenter trials. The Lancet.
2009: 373: 433-516.
2. HETLIOZ® (tasimelteon) Demonstrates Efficacy to Treat Jet Lag
Disorder in an 8 Hour Phase Advance Clinical Study.
https://www.prnewswire.com/news-releases/hetlioz-tasimelteon-demonstrates-efficacy-to-treat-jet-lag-disorder-in-an-8-hour-phase-advance-clinical-study-300607853.html
3. US Department of Commerce, International Trade
Administration, National Travel and Tourism Office. Profile
of U.S. Resident Travelers Visiting Overseas Destinations: 2015
Outbound.
http://tinet.ita.doc.gov/outreachpages/download_data_table/2015_Outbound_Profile.pdf
FORWARD LOOKING STATEMENTS
Various statements in this release are "forward-looking
statements" under the securities laws. Forward-looking statements
are based upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Important factors
that could cause actual results to differ materially from those
reflected in Vanda's forward-looking statements include, among
others: the ability of HETIOZ® to provide significant
benefit in the treatment of the symptoms of Jet Lag Disorder;
Vanda's ability to obtain marketing approval for the use of
HETLIOZ® in the treatment of Jet Lag Disorder; and other
factors that are described in the "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's annual report on Form 10-K for the
fiscal year ended December 31, 2017
and quarterly report on Form 10-Q for the fiscal quarter ended
March 31, 2018, which are on file
with the SEC and available on the SEC's website at www.sec.gov. In
addition to the risks described above and in Vanda's annual report
on Form 10-K and quarterly reports on Form 10-Q, other unknown or
unpredictable factors also could affect Vanda's results. There can
be no assurance that the actual results or developments anticipated
by Vanda will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, Vanda.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable
to Vanda or any person acting on its behalf are expressly qualified
in their entirety by the cautionary statements contained or
referred to herein. Vanda cautions investors not to rely too
heavily on the forward-looking statements Vanda makes or that are
made on its behalf. The information in this release is
provided only as of the date of this release, and Vanda undertakes
no obligation, and specifically declines any obligation, to update
or revise publicly any forward-looking statements, whether as a
result of new information, future events or otherwise.
Corporate 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.