WASHINGTON, Aug. 5, 2015 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today announced
publication of pivotal trial results related to patient entrainment
in the August issue of The Lancet. The published trial
results are from the SET (Safety and Efficacy of Tasimelteon)
and RESET (Randomized-withdrawal study of the Efficacy and Safety
of Tasimelteon to treat Non-24-Hour Sleep-Wake Disorder (Non-24))
Phase III studies of HETLIOZ® (tasimelteon), a
circadian regulator for the treatment of individuals suffering from
Non-24. Non-24 is a serious, rare and chronic circadian
rhythm disorder that affects a majority of totally blind
individuals who lack light perception, and consequently cannot
entrain (synchronize) their master body clock to the 24-hour
day. Tasimelteon, marketed under the tradename HETLIOZ®, is
currently approved for use in the United
States and in the European Union.
In the SET study, HETLIOZ® achieved the
primary endpoints of entrainment of the melatonin rhythm as
compared to placebo and clinical response as measured by
entrainment plus a score of greater than or equal to 3 on the
Non-24 Clinical Response Scale. HETLIOZ® also
demonstrated significant improvement versus placebo across a number
of sleep and wake parameters including measures of total sleep
time, daytime sleep duration, and timing of sleep, as well as in
the Clinical Global Impression of Change, an overall global
functioning scale. In treated patients, daytime sleep
decreased by 46 minutes per day in the worst 25% of days and
nighttime sleep increased by 57 minutes per day during the worst
25% of nights.
The RESET study demonstrated that continued treatment with 20mg
of HETLIOZ® is required to maintain entrainment
of the master body clock as measured by melatonin and cortisol
circadian rhythms in individuals with Non-24. Patients treated with
HETLIOZ® maintained their clinical benefits while
patients who received placebo showed significant deterioration in
measures of nighttime sleep, daytime sleep and timing of sleep.
Furthermore, discontinuation of HETLIOZ® resulted
in a rapid loss of circadian entrainment and a return to
non-entrained circadian rhythms, reinforcing the importance of
chronic therapy.
"The studies published today represent years of collaborative
work between Vanda, leading researchers in the field and patients
with Non 24," said Mihael H.
Polymeropoulos, M.D., President and CEO of
Vanda. "These clinical studies of Hetlioz in Non 24 led to
approval in the U.S. in 2014, and with the recent European
marketing authorization for Hetlioz, we are very excited about the
opportunity to make this much-needed treatment available to the
thousands of patients in Europe
who are suffering from this debilitating condition."
Twenty-four-hour biological rhythms are regulated by interaction
between environmental time cues and the internal circadian timing
system. The environmental light-dark cycle interacts with the
circadian timing system, and is the major time keeper for the
master body clock which regulates many biological rhythms. Non-24
patients frequently struggle with severe disruptions to the
sleep-wake cycle when the master body clock is out-of-sync with the
24-hour world.
"These results show HETLIOZ's efficacy as a circadian regulator,
which can serve as an alternative to light as a 24-hour time cue in
order to synchronize the circadian clock in the blind," said lead
investigator Steven W. Lockley,
Ph.D., Division of Sleep and Circadian Disorders, Brigham and
Women's Hospital, a teaching affiliate of Harvard Medical School. "These results also show
the importance of treating at a fixed clock time every day in order
to maintain entrainment of one's circadian body clock."
About Non-24-Hour Sleep-Wake Disorder
Non-24 is
a chronic circadian rhythm disorder resulting from loss of
entrainment of the master body clock to the 24-hour day, disrupting
the sleep-wake cycle. The sleep disturbance causes significant
distress and/or impairment in social, occupational and other
important areas of functioning. Non-24 affects the majority of
totally blind individuals and it has been estimated that
approximately 80,000 people in the United
States suffer from Non-24 and 130,000 people in
the European Union have the 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.
U.S. Indication and Important Safety Information About
HETLIOZ®
Indication
HETLIOZ® is indicated for the treatment of
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
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, 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.
Full U.S. HETLIOZ® Prescribing Information
can be found at: www.HETLIOZ.com.
About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company
focused on the development and commercialization of products for
the treatment of central nervous system disorders. For more on
Vanda, please visit www.vandapharma.com.
CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS
Various statements in this release, including, without
limitation, Vanda's assumptions regarding the efficacy of
HETLIOZ® as a circadian regulator, 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 are set forth 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, 2014 and quarterly report on Form 10-Q for
the quarter ended June 30, 2015,
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.
HETLIOZ® is a registered trademark of Vanda
Pharmaceuticals Inc.
Corporate Contact:
Jim
Kelly
Senior Vice President and Chief Financial
Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com
Media Contact:
Laney Landsman
Assistant
Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com
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SOURCE Vanda Pharmaceuticals Inc.