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Allergan Reports Acceptance of NDA from FDA for its Ubrogepant for Migraine

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Allergan Reports Acceptance of NDA from FDA for its Ubrogepant for Migraine

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  • The NDA filing is based on P-III ACHIEVE I (50 mg/100 mg) & ACHIEVE II (25mg/50mg) + two additional safety studies (UBR-MD-04 & 3110-105-002) assessing Ubrogepant vs PBO in patients with acute migraine
  • The ACHIEVE I & ACHIEVE II studies resulted in meeting its 1EPs and 2EPs i.e- reduces the pain with no bothersome symptoms and was well tolerated
  • Ubrogepant is a novel- oral gene-related peptide (CGRP) receptor antagonist and is used for broad spectrum treatment of migraine from episodic to chronic

Ref: Allergan | Image: Axios

Click here to­ read the full press release 

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