Breakthrough Clinical Results
Vanda Pharmaceuticals and the FDA have agreed on a collaborative framework to resolve disputes regarding HETLIOZ® (tasimelteon) and tradipitant. The FDA will expedite the re-review of the partial clinical hold on tradipitant for motion sickness and Vanda's sNDA for HETLIOZ® for jet lag disorder. Both parties will seek temporary pauses in ongoing administrative proceedings and litigation related to these drugs. Vanda will dismiss lawsuits challenging the clinical hold on tradipitant for motion sickness and the FDA's restrictions on providing information about HETLIOZ® for jet lag disorder.
Key Highlights
- FDA to expedite re-review of clinical hold on tradipitant for motion sickness.
- FDA to expedite re-review of sNDA for HETLIOZ® for jet lag disorder.
- Temporary pause sought for administrative proceedings regarding tradipitant for gastroparesis.
- Vanda to dismiss lawsuits related to tradipitant and HETLIOZ®.
Risk Factors and Comorbidities
Top 3 Risk Factors and Comorbidities for Motion Sickness
Motion sickness is a common condition that affects many individuals during travel or exposure to certain types of movement. Understanding the risk factors and comorbidities associated with this condition can help in prevention and management strategies.
Risk Factors
The top risk factors that contribute to the occurrence of motion sickness include:
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Genetic predisposition plays a significant role in determining susceptibility to motion sickness. Individuals with a family history of motion sickness are more likely to experience it themselves, suggesting a strong hereditary component to this condition.
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Age is another critical factor, with children between 2-12 years being particularly vulnerable. The susceptibility typically peaks around age 9 and gradually decreases with age as the vestibular system matures. However, elderly individuals may experience increased sensitivity due to age-related changes in sensory systems.
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Sex differences are notable, with females being significantly more prone to motion sickness than males. This difference may be related to hormonal influences, particularly during menstruation and pregnancy when susceptibility often increases.
Common Comorbidities
Motion sickness frequently coexists with several other conditions:
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Migraine disorders show a strong association with motion sickness. Individuals who suffer from migraines are more likely to experience motion sickness, suggesting shared neurological pathways in these conditions.
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Vestibular disorders such as Ménière's disease and benign paroxysmal positional vertigo (BPPV) commonly occur alongside motion sickness, as they affect the same balance and spatial orientation systems.
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Anxiety disorders often present as comorbidities, with generalized anxiety and panic disorders being particularly common. The relationship appears bidirectional, with anxiety potentially worsening motion sickness symptoms and the fear of experiencing motion sickness triggering anxiety.
Susceptible Populations
Certain groups show heightened vulnerability to motion sickness:
- Children (particularly in the 2-12 age range)
- Women (especially during pregnancy and menstruation)
- Migraine sufferers
- Individuals with vestibular system disorders
- Those with a history of concussion or traumatic brain injury
- People with anxiety disorders
- Individuals taking certain medications that affect the central nervous system
Understanding these risk factors and comorbidities can help healthcare providers develop targeted prevention strategies and treatment plans for those most susceptible to motion sickness.
Recent Studies
Recent Motion Sickness Studies and Interventions
Recent evidence has emphasized the role of the otoliths in the pathogenesis of motion sickness. Several new theories have emerged that may help explain motion sickness occurrence beyond the traditional sensory conflict theory.
A promising new direction in motion sickness research is the association of genetic polymorphism of the alpha2-adrenergic receptor with increased autonomic response to stress and motion sickness. Various physiological measures for evaluation and prediction of motion sickness have been tested, though no single parameter has yet been found to have high enough sensitivity and specificity for diagnosis or prediction of individual motion sickness susceptibility.
Interventions
Pharmacological interventions for motion sickness include: - Central acting anticholinergics - H1 antihistamines
These medications, while effective, may have adverse effects on psychomotor performance, limiting their use in drivers, pilots, and naval crewmembers.
Non-pharmacological countermeasures include all procedures that: - Reduce conflicting sensory input - Accelerate the process of multi-sensory adaptation - Promote psychological factors enabling subjects to cope with their condition
Future Directions
Recent studies may be relevant to understanding the link between motion sickness, migraine, vertigo, and anxiety. Based on recent neurochemical data, the development of new anti-motion sickness agents is a promising field of investigation.
Motion sickness continues to have a major influence on modern traveling activities and virtual reality immersion, making ongoing research in this area particularly important for improving quality of life and enabling new technologies.
Company drugs in pipeline
Vanda Pharmaceuticals Inc. Drug Pipeline Indications
Based on a thorough review of available information, there is insufficient data to provide details about Vanda Pharmaceuticals Inc.'s drug pipeline. The company's development programs, therapeutic focus areas, and pipeline candidates cannot be determined from the available information.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company that typically develops medications for various medical conditions, but specific details about which indications they are currently targeting with their drug development efforts are not available in the reviewed materials.
For accurate and current information about Vanda's pipeline products and the medical conditions they are addressing, it would be advisable to consult:
- The company's official website
- Recent investor presentations
- SEC filings such as annual reports
- Press releases from the company
- Industry databases that track pharmaceutical development
These sources would provide comprehensive information about the therapeutic areas Vanda is focusing on and the current status of their drug candidates in various stages of clinical development.