WASHINGTON, May 25, 2023
/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA)
today announced the results from its Phase III study of tradipitant
in motion sickness, confirming the previously reported results
demonstrating that tradipitant is effective in the prevention of
vomiting associated with motion sickness. The Phase III study was
conducted in real-world conditions on boats in the coastal waters
of the United States (U.S.).
The Motion Syros study was a multicenter, randomized,
double-blind, placebo-controlled study where 365 participants
embarked on boat trips under varied sea conditions and received
tradipitant 170 mg, tradipitant 85 mg, or placebo. Study
participants had a prior history of motion sickness and were
distributed across thirty-four boat trips that took place between
November 2021 and April 2023. Sea conditions and participant
evaluation of the symptoms of motion sickness were recorded for
each trip. The primary endpoint of the study was the effect of
tradipitant on vomiting induced by motion sickness.
Both 170 mg and 85 mg tradipitant doses were shown to be
superior to placebo in preventing vomiting with only 18.3% and
19.5% of participants experiencing vomiting on tradipitant 170 mg
and 85 mg respectively, as compared to 44.3% of participants on
placebo (p < 0.0001 for both).
Motion sickness remains an unmet need as various pharmacological
and non-pharmacological interventions suffer from low efficacy,
substantial side effects, or both. The U.S. Food and Drug
Administration (FDA) has not approved a new medication for motion
sickness in over forty years, since the approval of scopolamine, a
transdermal patch placed behind the ear, in 1979.
Vanda plans to continue the motion sickness clinical program and
pursue FDA approval upon completion of additional efficacy and
safety studies.
Table 1: Results of Motion Syros study for the Overall
population across all sea conditions
|
|
% Vomiting
|
Difference
v. Placebo
|
P-value
|
Tradipitant 170
mg
|
n=120
|
18.3 %
|
26.0 %
|
< 0.0001
|
Tradipitant 85
mg
|
n=123
|
19.5 %
|
24.8 %
|
< 0.0001
|
Placebo
|
n=122
|
44.3 %
|
|
|
Motion sickness
Motion sickness is a disorder characterized by a constellation
of symptoms, with nausea and vomiting being the primary
ones1. Motion sickness has plagued travelers for
thousands of years, as evidenced by the ancient Greek physician
Hippocrates who wrote "sailing on the sea proves motion disorders
the body"1. Historians theorize that motion sickness may
have changed the fate of civilization on several occasions, notably
the defeat of the Spanish Armada by the English in 1588 and the
negative effects on Napoleon's camel corps during the Egyptian
campaign in 17982.
It is believed that a discrepancy between actual body position
and perceived body position triggers the maladaptive response of
motion sickness3. Approximately 30% of the general
population is reported to suffer from motion sickness under
ordinary travel conditions that include sea, air and land
travel4.
According to IQVIA data, approximately two to three million
doses of Dramamine, a common motion sickness remedy, are purchased
monthly in the U.S. Dramamine treated patients represent only a
fraction of the people treated monthly for motion sickness.
Motion sickness is one of the most prevalent episodic disorders
in the world, whose prevalence has dramatically increased with
world population mobility over the last 100 years.
The U.S. Department of Transportation reports 10 billion trips
per year in mass transit (buses and trains), with an additional 965
million passenger trips in domestic and international air
travel5.
References
- Golding JF. Motion sickness. Handbook of Clinical Neurology.
2016: 371–90.
- Huppert D, Benson J, Brandt T. A historical view of motion
sickness-a plague at sea and on land, also with military impact.
Frontiers Neurology. 2017: 8:114.
- Reason JT. Motion sickness adaptation: a neural mismatch model.
Journal of the Royal Society of Medicine. 1988: 71: 819-829.
- Turner M, Griffin MJ. Motion sickness in public road transport:
passenger behavior and susceptibility. Ergonomics. 1999: 42:
444-461.
- U.S. Department of Transportation, Office of the Secretary of
Transportation, Bureau of Transportation Statistics. 2018
Transportation Statistics Annual Report.
About Vanda Pharmaceuticals Inc.
Vanda is a leading 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 and follow us on Twitter @vandapharma.
About Tradipitant
Tradipitant is a neurokinin-1 receptor antagonist licensed by
Vanda from Eli Lilly and Company. Tradipitant is currently in
clinical development for gastroparesis and motion sickness. The FDA
has imposed a partial clinical hold on tradipitant clinical
protocols of longer than 12 weeks duration.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
Various statements in this press release, including, but not
limited to statements regarding Vanda's plans to continue the
tradipitant motion sickness clinical program and pursue FDA
approval, 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, Vanda's ability
to successfully conduct additional efficacy and safety studies and
complete the clinical development of tradipitant in motion
sickness. Therefore, no assurance can be given that the 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. Forward-looking statements
in this press release should be evaluated together with the various
risks and uncertainties that affect Vanda's business and market,
particularly those identified in the "Cautionary Note Regarding
Forward-Looking Statements", "Risk Factors" and "Management's
Discussion and Analysis of Financial Condition and Results of
Operations" sections of Vanda's most recent Annual Report on Form
10-K, as updated by Vanda's subsequent Quarterly Reports on Form
10-Q, Current Reports on Form 8-K and other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov.
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 press release is
provided only as of the date of this press 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,
except as required by law.
Corporate Contact:
Kevin
Moran
Senior Vice President, Chief Financial Officer and
Treasurer
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.
202-734-3400
pr@vandapharma.com
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SOURCE Vanda Pharmaceuticals Inc.