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Vanda Pharmaceuticals Reports Positive Results from a Second Phase III Study of Tradipitant in Motion Sickness

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Vanda Pharmaceuticals announced positive results from the second Phase III study of tradipitant for motion sickness. Conducted in real-world conditions, the study involved 316 participants on boat trips across the U.S. coast between September 2023 and April 2024. Tradipitant significantly reduced vomiting, with 10.4% and 18.3% of participants experiencing vomiting on 170 mg and 85 mg doses, respectively, compared to 37.7% on placebo. Additionally, 13.3% of participants reported severe nausea and vomiting on tradipitant versus 33% on placebo. Vanda plans to submit a New Drug Application (NDA) for tradipitant in Q4 2024.

Positive
  • Tradipitant 170 mg showed a 70% reduction in vomiting risk compared to placebo.
  • Tradipitant 85 mg showed a 50% reduction in vomiting risk compared to placebo.
  • Tradipitant was effective in preventing severe nausea and vomiting, with rates significantly lower than placebo (13.3% vs. 33%).
  • Vanda Pharmaceuticals plans to submit a New Drug Application (NDA) for tradipitant in Q4 2024.
  • The study was conducted in real-world conditions, enhancing the reliability of the results.
Negative
  • No new medication for motion sickness has been approved by the FDA in over forty years, indicating regulatory challenges.
  • Tradipitant's effectiveness, although significant, still left 10.4% to 18.3% of participants experiencing vomiting.
  • The NDA submission for tradipitant is scheduled for Q4 2024, indicating a long wait before potential market approval.

The positive results from the second Phase III study of tradipitant signal a significant advancement in the treatment of motion sickness, a condition for which there has been scant innovation in over four decades. Vanda Pharmaceuticals has demonstrated statistically significant efficacy in preventing vomiting with both the 170 mg and 85 mg doses of tradipitant. Specifically, only 10.4% and 18.3% of participants on these doses experienced vomiting compared to 37.7% on placebo. These results suggest a substantial improvement over existing treatments like Dramamine, commonly used but often limited by side effects and lower efficacy.

The real-world conditions under which the study was conducted add robustness to the findings. Conducted across varied sea conditions, the study's design strengthens the credibility of the drug's efficacy, potentially making tradipitant a game-changer in motion sickness treatment. With motion sickness affecting approximately 30% of the general population during travel, the market potential is vast.

From a clinical perspective, the reduction in the incidence of severe nausea and vomiting to 13.3% in tradipitant-treated participants compared to 33.0% in the placebo group further underscores the drug's effectiveness. This could significantly improve the quality of life for a large patient population. However, it will be important to monitor any potential side effects in larger post-marketing studies once the drug is approved.

Vanda Pharmaceuticals' announcement about the positive results from its Phase III study of tradipitant could have significant financial implications. Investors should note the potential market size; with an estimated 30% of the general population experiencing motion sickness during travel, there's a substantial addressable market. Additionally, the FDA has not approved a new medication for motion sickness in over 40 years, indicating a high unmet need that tradipitant could fulfill.

With a New Drug Application (NDA) expected to be submitted in Q4 2024, there are several financial milestones ahead. Successful FDA approval could boost Vanda's market position and revenues significantly. However, investors must remain aware of the inherent risks in the approval process, including potential delays or additional data requirements from the FDA.

Another critical aspect to consider is Vanda's ability to commercialize tradipitant effectively. This includes marketing strategies, pricing and distribution plans. The success of these efforts will be pivotal in determining the drug’s financial impact. Finally, it's worth considering the competitive landscape. Although current treatments like Dramamine dominate the market, tradipitant's superior efficacy presents a compelling case for market disruption.

•         New Drug Application expected to be submitted in Q4 2024

WASHINGTON, May 15, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the results from its second Phase III study of tradipitant in motion sickness, confirming the previously reported results of two efficacy studies demonstrating that tradipitant is effective in the prevention of vomiting associated with motion sickness. This Phase III study was conducted in real-world conditions on boats in the coastal waters of the United States (U.S.).

The Motion Serifos study was a multicenter, randomized, double-blind, placebo-controlled study where 316 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 twenty boat trips that took place between September 2023 and April 2024. 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 170 mg on vomiting. The key secondary endpoints were: (1) the effect of tradipitant 85 mg on vomiting and (2) the effect of tradipitant in preventing severe nausea and vomiting.

Both 170 mg and 85 mg tradipitant doses were shown to be superior to placebo in preventing vomiting with only 10.4% and 18.3% of participants experiencing vomiting on tradipitant 170 mg and 85 mg respectively, as compared to 37.7% of participants on placebo (p=0.000002, p=0.0014) resulting in reduction of risk of vomiting of over 70% in the tradipitant 170 mg group and of over 50% in the tradipitant 85 mg group.

Tradipitant (170 mg and 85 mg together) was also effective in the endpoint of prevention of severe nausea and vomiting (tradipitant 13.3%, placebo 33.0%, p=0.00003).

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 expects to submit a New Drug Application (NDA) for tradipitant in the prevention of vomiting induced by motion to the U.S Food and Drug Administration (FDA) in the fourth quarter of 2024.

Table 1: Results of Motion Serifos study for the overall population across all sea conditions

Prevention of
vomiting


% Vomiting

Difference
v. Placebo

p-value

Tradipitant 170 mg

n=106

10.4 %

27.3 %

0.000002

Tradipitant 85 mg

n=104

18.3 %

19.4 %

0.0014

Placebo

n=106

37.7 %



Prevention of
severe nausea
and vomiting


% Severe
Nausea
and Vomiting

Difference
v. Placebo

p-value

Tradipitant

n=210

13.3 %

19.7 %

0.00003

Placebo

n=106

33.0 %



Motion sickness

Motion sickness is a disorder characterized by a constellation of symptoms, with nausea and vomiting being the primary ones.1 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 1798.2

It is believed that a discrepancy between actual body position and perceived body position triggers the maladaptive response of motion sickness.3 Approximately 30% of the general population is reported to suffer from motion sickness under ordinary travel conditions that include sea, air and land travel.4

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 travel.5

References

  1. Golding JF. Motion sickness. Handbook of Clinical Neurology. 2016: 371–90.
  2. 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.
  3. Reason JT. Motion sickness adaptation: a neural mismatch model. Journal of the Royal Society of Medicine. 1988: 71: 819-829.
  4. Turner M, Griffin MJ. Motion sickness in public road transport: passenger behavior and susceptibility. Ergonomics. 1999: 42: 444-461.
  5. 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 pursue FDA approval for tradipitant for the prevention of vomiting induced by motion, are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances 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 prepare and submit a NDA for tradipitant for the prevention of vomiting induced by motion in the fourth quarter of 2024. 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

Jim Golden / Jack Kelleher / Dan Moore
Collected Strategies
VANDA-CS@collectedstrategies.com

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SOURCE Vanda Pharmaceuticals Inc.

FAQ

What are the results of Vanda Pharmaceuticals' Phase III study of tradipitant for motion sickness?

The study showed that tradipitant 170 mg and 85 mg significantly reduced vomiting, with only 10.4% and 18.3% of participants vomiting compared to 37.7% on placebo.

When does Vanda Pharmaceuticals plan to submit the New Drug Application (NDA) for tradipitant?

Vanda Pharmaceuticals plans to submit the NDA for tradipitant in Q4 2024.

How effective is tradipitant in preventing severe nausea and vomiting?

Tradipitant significantly reduced severe nausea and vomiting to 13.3% compared to 33% on placebo.

Under what conditions was the Phase III study of tradipitant conducted?

The Phase III study was conducted in real-world conditions on boats in the coastal waters of the U.S.

What percentage of participants experienced vomiting on placebo in the Phase III study of tradipitant?

37.7% of participants on placebo experienced vomiting.

What were the doses of tradipitant tested in the Phase III study?

The doses tested were 170 mg and 85 mg.

Vanda Pharmaceuticals Inc.

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