El Jian completes 2 clinical studies for acute treatment of migraines
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, Allergan announced that it has completed two clinical studies for acute treatment of migraines and has obtained positive safety and tolerability dataubrogepantubrogepant is a new, highly efficient, oral calcitonin gene-related peptide (CGRP) receptor antagonist developed for the treatment of acute migrainesCGRP and its receptors are expressed in the nervous system regions associated with migraine pathophysiologyCGRP receptor antagonization is a new mechanism of action for acute treatment of migraines, which is significantly different from the existing metastases (serotonin 1B/ 1D agonists) and opioiddrugs(significantly different mechanisms of action)At present, CGRP receptors have become a hot target for the development of migraine drugsthe first
study (UBR-MD-04) to assess the long-term safety and tolerance of ubrogepant (50mg and 100mg) used in acute treatment in adult patients with migraines compared to routine care treatment for one year, the data continue to support the positive safety and tolerability characteristics of ubrogepantsecond study (3110-105-002) assessed the healthof ubrogepant (100mg) in(liver safety and tolerance for 8 weeks relative to placebo treatment in study participants), and data confirmed that ubropantt had no drug-induced liver damage signals in healthy volunteersbased on the successful completion of the above-mentioned 2 safety studies, as well as previously reported efficacy and safety data from 2 critical Phase III clinical studies (ACHIEVE I (UBR-MD-01), ACHIEVE II (UBR-MD-02), Aerjian It is planned tothe FDA(NDA) to the U
.S FDA in the first quarter of 2019, (the company is expected to be the first oral CGRP receptor antagonist to be submitted in the U.S market for acute treatment of migraines (with or without precursors)
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