WASHINGTON, July 13, 2020 /PRNewswire/ -- Vanda
Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) announced today that
the U.S. Food and Drug Administration (FDA) has authorized a single
patient in an Individual Patient Expanded Access protocol
(VP-VLY-686-3303). This patient had previously participated
in a randomized study of tradipitant in gastroparesis for 12
weeks. The patient and treating physician requested expanded
access to continue treatment beyond 12 weeks, as the treating
physician had judged that tradipitant was the only treatment that
effectively managed the patient's gastroparesis symptoms.
The FDA's Division of Gastroenterology has authorized expanded
access to tradipitant for this patient for an additional 6 months
under this protocol with the potential to renew upon written
request containing additional safety information collected during
those 6 months.
The 12-week randomized placebo-controlled Phase III study of
tradipitant in patients with gastroparesis that this patient
originally participated in is ongoing. In December 2018, Vanda reported results of a Phase
II study of tradipitant in gastroparesis where tradipitant was
shown to be effective at reducing nausea and other cardinal
symptoms of gastroparesis and well tolerated.
About Tradipitant
Tradipitant is an NK-1R antagonist licensed by Vanda from Eli
Lilly and Company. Tradipitant is currently in clinical development
for gastroparesis, motion sickness and atopic dermatitis. The
FDA has imposed a partial clinical hold on tradipitant clinical
protocols of longer than 12 weeks duration. The partial clinical
hold does not apply to the individual-patient protocol described
above.
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.
Corporate Contact:
AJ Jones II
Chief Corporate Affairs and Communications Officer
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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content:http://www.prnewswire.com/news-releases/fda-grants-authorization-for-individual-patient-expanded-access-protocol-for-the-use-of-tradipitant-for-gastroparesis-301092427.html
SOURCE Vanda Pharmaceuticals Inc.