Vanda Pharmaceuticals recently announced that its core pipeline product, traditional vomiting (brand name: NEREUS™), has been approved by the FDA for the prevention of exercise-induced vomiting.

40 years since the approval of scopolamine transdermal patches in 1979. This approval is a significant milestone.

This approval is primarily based on three pivotal clinical trials: two Phase III real-world induced trials conducted at sea and a supportive study, with all participants having a clear history of motion sickness.

In the Motion Syros trial (during November 2021 to April 2023, a total of 365 adult subjects participated in 34 sea trials in the waters near the United States, during which nausea and vomiting symptoms were assessed every 30 minutes using a standardized questionnaire, and the sailing time was approximately 4 hours), the incidence of vomiting in the drug group was significantly lower than that in the placebo group (170 mg group 18.3%, 85 mg group 19.5%, placebo group 44.3%, p<0.0001) ;

In the second study of the Motion Serifos trial (during September 2023 to April 2024, 316 participants took part in 20 sea trials under different sea conditions), the incidence of vomiting in the drug group was also significantly lower than that in the placebo group (10.4% in the 170mg group, 18.3% in the 85mg group, and 37.7% in the placebo group) , with the two dosage groups reducing the risk of vomiting by more than 70% and 50%, respectively.
Overall pivotal trial data showed that traditionaltitant has a sustained and significant effect in preventing vomiting, with a good safety profile, consistent with short-term use characteristics.

Motion sickness, also known as motion sickness, seasickness, airsickness, or cosmic motion sickness, is a series of physiological reactions caused by various factors that lead to a distorted perception of motion. The pathogenesis of this condition is complex, and several theories are commonly cited, including the sensory conflict theory, the neural mismatch theory, and the vestibular hypersensitivity theory.

The development of tradipitant primarily draws on the sensory conflict theory and neurotransmitter hypothesis. This theory posits that sensory conflict between visual, vestibular, and proprioceptive inputs triggers the release of substance P in the central nervous system, activating NK-1 receptors and ultimately leading to nausea and vomiting. Tradipitant, through its potent and selective blocking of NK-1 receptors, directly targets this pathological pathway.

Currently, NK-1 receptor antagonists are commonly used antiemetic drugs in antitumor treatment. The main drugs of this type available in China are aprepitant (oral) and fosaprepitant (intravenous drip).

However, tradipitant was not developed for cancer-related antiemetic indications, but instead for gastroparesis and the more marketable atopic dermatitis (AD) pruritus . Among these, the AD-related research has entered phase III clinical trials. Unfortunately, in a phase III study of 375 adult patients with mild to severe AD, although the drug group showed a trend toward reducing pruritus, it did not reach statistical significance.

Some analysts predict that, for the single indication of motion sickness, traditional anti-motion sickness alone, peak annual sales of traditional anti-motion sickness in the US market could exceed $100 million.

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