Vanda Pharmaceuticals Inc. filed SEC Form 8-K: Regulation FD Disclosure
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| Item 7.01. | Regulation FD Disclosure. |
On March 14, 2025, Vanda Pharmaceuticals Inc. (“Vanda”) issued a post on the social media platform X announcing that the U.S. Food and Drug Administration (the “FDA”) has accepted for filing Vanda’s new drug application for tradipitant for the treatment of motion sickness and that the FDA has set December 30, 2025 as the target date for its decision under the Prescription Drug User Fee Act. The full text of the post was as follows:
“The @US_FDA informed us that it has “accepted for filing” Vanda’s application for tradipitant for motion sickness, and it intends to again violate the Food Drug and Cosmetic Act by completing its review on December 30, 2025 - 12 months after the date of the submission of the application and 6 months after the statutory deadline. The letter was signed by the Director, Division of Gastroenterology at the FDA.
FDA also said it will take 10 months to review whether the clinical study results “provide evidence of efficacy” despite the fact that tradipitant was tested in two large, controlled studies in 681 subjects and the results, as shown below, were statistically significant in preventing motion-induced vomiting.
This is exemplary of a broken, unaccountable FDA that unfairly and irresponsibly stifles innovation and hurts the American public. We are showing the summary of the two large motion sickness studies for anyone’s inspection.
The percentage of participants who vomited during vehicle travel as assessed by the VA questionnaire is summarized in Table 41. The percentage of participants who vomited was significantly lower in both the 170 mg tradipitant group (14.6%, p<0.0001) and the 85 mg tradipitant group (18.9%, p<0.0001) as compared to the placebo group (41.2%).
| Table 41: | Overall Vomiting Pooled 3401/3404 (ITT Population) |
| Tradipitant 170 mg (N=226) |
Tradipitant 85 mg (N=227) |
Placebo (N=228) | ||||
| Overall Vomiting, n/N (%) |
33/226 (14.6) | 43/227 (18.9) | 94/228 (41.2) | |||
| p-value (vs Placebo)c |
<0.0001 | <0.0001 | ||||
| Risk difference for vomiting (95% CI)a |
-0.27 (-0.345, -0.188) | -0.22 (-0.305, -0.141) | ||||
| Adjusted relative risk for vomiting (95% CI)b |
0.36 (0.252, 0.505) | 0.46 (0.337, 0.621) |
| a | Wald interval |
| b | Adjusted relative risk and 95% CI are based on the ratio of overall vomiting rates for Tradipitant versus placebo, stratified by the pooling port.” |
The information furnished pursuant to this Item 7.01 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934 (as amended, the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: March 17, 2025 | VANDA PHARMACEUTICALS INC. | |||||
| By: | /s/ Timothy Williams | |||||
| Name: | Timothy Williams | |||||
| Title: | Senior Vice President, General Counsel and Secretary | |||||